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Clinical Trials

As part of an academic medical center, the Department of Medicine at Northwestern University Feinberg School of Medicine aims to improve the human health through scientific research.

About Clinical Trials

Clinical trials test or study drugs, surgical procedures, medical devices or interventions with human subjects. They look to determine their safety and effectiveness in relation to treating specific diseases. Clinical trials are part of clinical research and are at the heart of all medical advances.

Department of Medicine Clinical Trials

The following searchable list includes all Department of Medicine clinical trials currently looking for participants.

Contact Us

Please feel free to contact us with inquiries about any of our ongoing research.

Trials

A Registry of Interstitial Lung Disease Patients

The purpose of this registry is to collect clinical information about people with interstitial lung disease (ILD) to help us better understand the causes of ILD and determine if particular types of treatment work better for some causes of ILD than others. The Registry will also be used to determine …
The purpose of this registry is to collect clinical information about people with interstitial lung disease (ILD) to help us better understand the causes of ILD and determine if particular types of treatment work better for some causes of ILD than others. The Registry will also be used to determine who might be eligible for and interested in participating in future studies related to ILD.

Participants agree to allow the collection of information from the medical record for research purposes and agree to allow us to contact them about future studies. Participants may also complete questionnaires during their standard of care visits, participate in an optional frailty study by taking a brief physical ability test at the time of standard of care visits, give optional blood for research, and optionally allow us to contact them about their health on an annual basis.

  • At least 18 years old
  • Diagnosis of interstitial lung disease (ILD)
  • Receives care at Northwestern's Pulmonary Clinic
Dematte DDematte D'Amico, Jane E
  • Map it 675 N. Saint Clair St. Eighteenth Floor, Suite 250
    Chicago, IL
STU00060593
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INtervention Study In OverweiGHT Patients with COPD (INSIGHT COPD)

We are conducting the INSIGHT COPD study because symptoms of chronic obstructive pulmonary disease (COPD) and high body mass index (BMI) overlap. There are many medications for patients with COPD, but there is little mention of weight loss as a possible treatment in current research. We are trying to find …
We are conducting the INSIGHT COPD study because symptoms of chronic obstructive pulmonary disease (COPD) and high body mass index (BMI) overlap. There are many medications for patients with COPD, but there is little mention of weight loss as a possible treatment in current research. We are trying to find out if a lifestyle program that promotes modest weight loss and increased physical activity will improve COPD symptoms for those with a high BMI. We hope that the program will lead to weight loss and better exercise tolerance. We are also looking at the effects on shortness of breath, quality-of-life, and cardiovascular disease risk factors.

1 year, 2 visits.

40 years of age or older with COPD, wants to participate in a healthy lifestyle intervention, body mass index of 25 -44.9
Kalhan, RaviKalhan, Ravi
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02634268 STU00204332
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Losartan Effects on Emphysema Progression (LEEP)

This research is being done to look at how a medicine called Losartan helps people with Chronic Obstructive Pulmonary Disease (COPD) with emphysema – a disease of the lungs. COPD is often caused by cigarette smoking. It includes the symptoms of emphysema and chronic bronchitis. Although some medications for COPD reduce symptoms and prevent exacerbations, few medications have been shown to reduce the damage to the lungs in people with COPD. Losartan is a medicine used for treatment of high blood pressure. Losartan has been shown to slow the damage to lungs caused by COPD in animals. We would like to find out if taking Losartan can slow the damage to lungs caused by COPD. We will use images of participants’ lungs taken with high resolution computed tomography (HRCT) to measure changes in the lung. We also want to find out if Losartan has effects on blood and breathing tests.
40 years of age or older with COPD, controlled blood pressure, no flare of COPD in the last 6 weeks or the use of antibiotics or prednisone
Kalhan, RaviKalhan, Ravi
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02696564 STU00204797
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Pathogenic Wnt-beta catenin target genes in macrophages and fibrosis

The purpose of this study is to better understand the development of scleroderma-related lung fibrosis (ILD). We would like to investigate the role of macrophages and other important cells in the development of ILD. Macrophages are types of white blood cells important in the immune system. In healthy people, …
The purpose of this study is to better understand the development of scleroderma-related lung fibrosis (ILD). We would like to investigate the role of macrophages and other important cells in the development of ILD. Macrophages are types of white blood cells important in the immune system. In healthy people, macrophages produce proteins that activate the immune system to assist in tissue repair. However, there is evidence that in people with scleroderma, the macrophages behave abnormally and contribute to scarring in the lungs.

Patients who participate in this study will:

  • donate fluid collected from their lungs during a bronchoscopy (taken at the time they are already scheduled to have a bronchoscopy or during their scheduled endoscopy)
  • give a blood sample
  • give esophageal biopsies (taken during their scheduled endoscopy)
  • as an option, give skin biopsies

  • At least 18 years old
  • Meet criteria for systemic sclerosis
  • Receive care at Northwestern Medicine in Rheumatology, Pulmonary & Critical Care, and/or Gastroenterology scleroderma clinics
  • Plan to undergo a standard of care bronchoscopy or endoscopy at Northwestern or a research bronchoscopy through a separate Northwestern study
Perlman, Harris RPerlman, Harris R
  • Map it 633 N. St. Clair St.
    Chicago, IL
STU00207083
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A pilot study of use of oscillation and lung expansion (OLE) therapy in patients admitted for COVID-19 (Protocol # CR-RR-2020-002)

This study is being done to evaluate the use of the MetaNeb System as an airway clearance and lung expansion therapy for patients with COVID-19 who require high-flow oxygen therapy. The MetaNeb System can be used for therapy when patients are on high-flow oxygen and may make …
This study is being done to evaluate the use of the MetaNeb System as an airway clearance and lung expansion therapy for patients with COVID-19 who require high-flow oxygen therapy. The MetaNeb System can be used for therapy when patients are on high-flow oxygen and may make it easier to clear sputum out of the lungs. This study will evaluate the effect of the therapy on how quickly patients recover and can leave the hospital.

Participants in this study will be:

  • Randomized to receive either the MetaNeb therapy in addition to their standard of care or standard of care treatment without the MetaNeb therapy
  • If randomized to MetaNeb, patients will receive treatment with the MetaNeb therapy for a maximum of 7 days (28 treatments) while receiving high-flow oxygen therapy.

  • At least 18 years old
  • Tested positive or person under investigation for COVID-19 infection
  • Treated with high-flow oxygen therapy
  • High-flow oxygen therapy initiated within the past 72 hours
  • Other exclusion criteria apply
Wolfe, Lisa FWolfe, Lisa F
  • Map it 675 N. Saint Clair St. Eighteenth Floor, Suite 250
    Chicago, IL
  • Map it 201 E. Huron St.
    Chicago, IL
NCT04582214 STU00212652
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A Multicenter, Adaptive, Randomized Controlled Platform Trial of the Safety and Efficacy of Antithrombotic and Additional Strategies in Hospitalized Adults with COVID-19

Patients with COVID-19 disease are at risk of blood clots, which may affect many parts of the body. It is recommended that patients hospitalized with COVID-19 disease be placed on a blood thinner called heparin to prevent clots. The purpose of this study is to determine if adding …
Patients with COVID-19 disease are at risk of blood clots, which may affect many parts of the body. It is recommended that patients hospitalized with COVID-19 disease be placed on a blood thinner called heparin to prevent clots. The purpose of this study is to determine if adding a platelet inhibitor, a different type of blood thinner, will be even better at reducing the risk of blood clots. All of these blood thinner medications are already approved by the United States Food and Drug Administration (FDA) for preventing clots in different situations. We do not currently know the best combination of these drugs in people hospitalized with COVID-19.

Participants in this study will receive an assigned study treatment that will last up to 14 days or until discharge from the hospital, whichever comes first. The study team will also contact participants about 90 days after hospital discharge and about 1 year after hospital discharge to check on the participant's health.

Currently, participants will be randomly assigned to either blood thinner alone or blood thinner with platelet inhibitor.

Participants may also optionally give blood samples at four different times during their hospital stay. The blood will be stored for future genetic research.

  • At least 18 years old
  • Hospitalized for COVID-19
  • Enrolled within 72 hours of hospital admission or 72 hours of positive COVID test
  • Expected to require hospitalization for more than 72 hours
  • Additional inclusion/exclusion criteria apply
Martin, Karlyn AMartin, Karlyn A
  • Map it 675 N. Saint Clair St. Eighteenth Floor, Suite 250
    Chicago, IL
  • Map it 201 E. Huron St.
    Chicago, IL
NCT04505774 STU00213958
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Macitentan in inoperAble or persistent/reCurrent chronIc ThromboEmbolic Pulmonary Hypertension (MACiTEPH) - A prospective, randomized, double-blind, multicenter, placebo-controlled, parallel group, adaptive Phase 3 study with open-label extension to evaluate efficacy and safety of macitentan 75 mg in inoperable or persistent/recurrent chronic thromboembolic pulmonary hypertension

The purpose of this trial is to see if macitentan 75 mg versus placebo is useful and safe for treating patients with chronic thromboembolic pulmonary hypertension (CTEPH). Macitentan 10 mg once-daily is approved in many countries around the world for the treatment of pulmonary arterial hypertension (PAH). Macitentan at …
The purpose of this trial is to see if macitentan 75 mg versus placebo is useful and safe for treating patients with chronic thromboembolic pulmonary hypertension (CTEPH). Macitentan 10 mg once-daily is approved in many countries around the world for the treatment of pulmonary arterial hypertension (PAH). Macitentan at a dose of 75 mg is not approved for use by any Regulatory Authority in any country. This means that macitentan is an investigational drug, since it is not approved for use in patients with CTEPH, and can only be used in a research study such as this one.

Participants will be in this study for up to 3.5 years. Participants who choose to join the open label part of the study will be in the study between 2.5 and 6 years.

Participants will:

  • Randomly assigned to macitentan 75 mg or placebo
  • Return for study visits at least 10 times for the first 7 months and then every 12 weeks until the end of the double-blind period.
  • Receive a phone call at week 5 and week 9.
  • If continuing in the open-label study, return for 7 visits for the first 6 months and then every 6 months until the end of the open-label period.
  • Study visits may include health questionnaires, physical exam, blood draw, EKG, 6 minute walk test, urine pregnancy test.
  • Monitor body weight at least once per week at home until week 12.
  • Wear a device to monitor sleep and activity until week 28.
  • Complete questionnaires at home on a mobile device provide to you during the double-blind period.
  • Optionally undergo a right heart catheterization at week 28.

Participants will be paid a stipend after completion of each study visit.

  • Age 18 to 80 years old
  • Diagnosis of CTEPH with one of the following:
  • Inoperable due to the localization of the obstruction being surgically inaccessible
  • Persistent/recurrent CTEPH after BPA and deemed inoperable
  • Persistent/recurrent CTEPH after PEA (including PEA followed by BPA)
    • 6 minute walk test distance between 100 and 450 meters
    • Receiving riociguat for standard of care, unless it is contraindicated
    • If a female of childbearing potential, must use a highly effective method of contraception until at least 30 days after the last dose of study drug
    • Additional exclusion criteria apply
    Cuttica, Michael JCuttica, Michael J
    • Map it 675 N. Saint Clair St. Eighteenth Floor, Suite 250
      Chicago, IL
    NCT04271475 STU00212942
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    Immune response to SARS-CoV-2 vaccination in sarcoidosis

    The purpose of this study is to investigate the antibody and immune responses to the COVID-19 vaccine in patients with sarcoidosis, both treated and not treated with immunosuppressive medications, compared to healthy controls. This study will address a critical gap in our understanding of vaccine responses in people with …
    The purpose of this study is to investigate the antibody and immune responses to the COVID-19 vaccine in patients with sarcoidosis, both treated and not treated with immunosuppressive medications, compared to healthy controls. This study will address a critical gap in our understanding of vaccine responses in people with sarcoidosis.

    Participants will:

    • Complete a brief screening/health history questionnaire
    • Give 5-7 tubes of blood

    Sarcoidosis Patients

    • At least 18 years old
    • Diagnosis of sarcoidosis and receiving care at Northwestern
    • Completed vaccination with the Pfizer (2 dose), Moderna (2 dose), or Johnson & Johnson (1 ose) vaccine for SARS-CoV-2 (COVID-19) at least 2 weeks prior to enrollment
    • If a vaccine booster was received, must have been received at least 2 weeks prior to enrollment

    Controls

    • At least 18 years old
    • Completed vaccination with the Pfizer (2 dose), Moderna (2 dose), or Johnson & Johnson (1 ose) vaccine for SARS-CoV-2 (COVID-19) at least 2 weeks prior to enrollment
    • If a vaccine booster was received, must have been received at least 2 weeks prior to enrollment
    • Not diagnosed with an autoimmune disease, chronic lung disease, heart disease, or cancer
    • Not taking any immunosuppressive medications

    Sporn, Peter HSporn, Peter H
    • Map it 675 N. Saint Clair St. Eighteenth Floor, Suite 250
      Chicago, IL
    STU00215567
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    A Prospective, Single-Arm, Multicenter Study to Investigate the Safety and Effectiveness of SAPIEN 3/SAPIEN 3 Ultra Transcatheter Heart Valve Implantation in Patients With a Failing Aortic Bioprosthetic Valve

    This study will evaluate the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve (THV) Model 9600TFX and associated delivery systems for the aortic valve in valve procedure. Participants in this study will have the investigational (experimental) Edwards SAPIEN 3 transcatheter aortic heart valve (study device) to replace …
    This study will evaluate the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve (THV) Model 9600TFX and associated delivery systems for the aortic valve in valve procedure. Participants in this study will have the investigational (experimental) Edwards SAPIEN 3 transcatheter aortic heart valve (study device) to replace the failing bioprosthetic aortic valve access through the heart through a small incision is in the chest. The study device and its delivery system are investigational, which means they are not approved for commercial use by the U.S. Food and Drug Administration (FDA) for the valve in bioprosthetic valve procedure. The previous generation of SAPIEN valves, SAPIEN XT, was approved for commercial use by the FDA for a failed surgical bioprosthetic aortic valve in October 2015. The study device is a bioprosthetic heart valve made out of man-made materials and animal tissue. It is an artificial device made to replace the diseased aortic heart valve. Each valve consists of a stent (mesh tube made of metal) to hold the study device in its intended position and valve leaflets (made of biological material derived from cows) to direct the flow of blood in the heart. Study participation will last approximately 10 years. Participants will be asked to come to clinic for study visits at 30 days, 6 months, and 12 months after the study procedure and then annually until 10 years after the procedure. We expect up to 19 people will be enrolled at Northwestern. The study expects to enroll up to 125 people internationally.
    Malaisrie, S ChrisMalaisrie, S Chris
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03003299 STU00204739
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    Clinical Study of the Edwards Cardioband™ Tricuspid Valve Reconstruction System

    This study is recruiting patients with tricuspid regurgitation (a condition in which blood flow through the tricuspid valve of the heart flows in the wrong direction) that may benefit from a new tricuspid valve reconstruction system. This is an early feasibility clinical research study that will evaluate the safety and …
    This study is recruiting patients with tricuspid regurgitation (a condition in which blood flow through the tricuspid valve of the heart flows in the wrong direction) that may benefit from a new tricuspid valve reconstruction system. This is an early feasibility clinical research study that will evaluate the safety and performance of the Edwards Cardioband Tricuspid Valve Reconstruction System, (the “Study Device” ). The Study Device includes an adjustable implant that is delivered and anchored to the tricuspid valve by a transfemoral delivery system, meaning it is inserted in a minimally invasive procedure through a puncture into a vein in the leg. The Cardioband Implant will be positioned around the tricuspid valve and will be adjusted to reduce the size of the valve, thus improving the tricuspid regurgitation. Up to 15 patients will be enrolled in this study at up to 15 sites. All enrolled study patients will be assessed at the following intervals: screening/baseline, procedure, discharge, 1 month, 6 months, 1 year and annually for 5 years post implant procedure.
    Davidson, Charles JDavidson, Charles J
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03382457 STU00207338
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    AF STOP: AF Substrate as an Outcome and Predictor of successful AF ablation

    To improve the understanding of factors associated with the atrial myopathy in people with AF or people at risk for developing AF
    Primary Inclusion Criteria:
    • Patients ≥ 18 years old
    • Patients with paroxysmal or early persistent AF undergoing routine pulmonary vein isolation (PVI)
    • Subjects who are scheduled to undergo clinically ordered cardiac MRI for planning of AF ablation

    Primary Exclusion Criteria:

    • Longstanding persistent AF (continuous AF > 1 year) or AF from a reversible cause
    • Previous catheter or surgical ablation for AF
    • Contraindication to MRI
    • Advanced chronic renal insufficiency (GFR < 30 mL/min/1.73 m2), anemia (hemoglobin < 10 g/dL) or thrombocytopenia (platelet count < 100K/UL)
    • History of pulmonary emboli, CVA or TIA (within the past 6 months), atrial clot/thrombus on imaging, or blood clotting/bleeding abnormalities
    Passman, Rod SPassman, Rod S
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00207885
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    Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical Trial (CLASP IID/IIF): A prospective, multicenter, randomized, controlled pivotal trial to evaluate the safety and effectiveness of transcatheter valve repair with the Edwards PASCAL Transcatheter Valve Repair System compared to Abbott MitraClip in patients with mitral regurgitation

    The objectives of this pivotal clinical trial are to evaluate the safety and effectiveness of the PASCAL System for transcatheter mitral valve repair compared to the MitraClip system in the treatment of patients with symptomatic degenerative mitral regurgitation (DMR) and who have been determined to be at prohibitive risk for …
    The objectives of this pivotal clinical trial are to evaluate the safety and effectiveness of the PASCAL System for transcatheter mitral valve repair compared to the MitraClip system in the treatment of patients with symptomatic degenerative mitral regurgitation (DMR) and who have been determined to be at prohibitive risk for mitral valve surgery by the Heart Team.

    Primary Inclusion Criteria:

  • Patient is determined to be at prohibitive risk for mitral valve surgery by a heart team
  • Mitral regurgitation (3+ to 4+) by echo (TTE or TEE) as measured by the core lab
  • Left ventricular ejection fraction (LVEF) ≥ 20%
  • Davidson, Charles JDavidson, Charles J
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03706833 STU00208635
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    Transcatheter Aortic Valve Replacement to UNload the Left ventricle in patients with ADvanced heart failure: a randomized trial (TAVR UNLOAD)

    The purpose of this study is to evaluate the use of a device to treat patients with Heart Failure (HF - inability of the heart to pump enough blood to meet the body's needs) who have moderate aortic stenosis (AS - narrowing of the aortic valve resulting in obstructed blood flow). …

    The purpose of this study is to evaluate the use of a device to treat patients with Heart Failure (HF - inability of the heart to pump enough blood to meet the body's needs) who have moderate aortic stenosis (AS - narrowing of the aortic valve resulting in obstructed blood flow). This clinical trial is comparing the safety and effectiveness of TAVR (Transcatheter Aortic Valve Replacement) with the Edwards SAPIEN 3 Transcatheter Heart Valve (the Study Valve) and OHFT (optimal heart failure therapy) versus OHFT alone in HF patients with moderate AS. The study valve has not been approved by the U.S. Food and Drug Administration (FDA) for use in this patient population, and therefore it's use in this study is considered investigational.
    This study is looking for patients with Heart Failure and moderate Aortic Stenosis. Aortic Stenosis is a narrowing of the aortic valve opening,which blocks blood flow from the heart and causes symptoms such as chest pain,fainting and shortness of breath.
    Davidson, Charles JDavidson, Charles J
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02661451 STU00208415
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    The “RADIANCE II” Pivotal Study A Study of the ReCor Medical Paradise System in Stage II Hypertension

    This study is enrolling patients who have high blood pressure ("hypertension") and are taking two medications or fewer for it. It is believed that in some patients with high blood pressure, the nerves surrounding the blood vessels leading to the kidneys (renal arteries) are too active and that this may …
    This study is enrolling patients who have high blood pressure ("hypertension") and are taking two medications or fewer for it. It is believed that in some patients with high blood pressure, the nerves surrounding the blood vessels leading to the kidneys (renal arteries) are too active and that this may be causing high blood pressure. Renal denervation is a procedure where a catheter is placed inside these blood vessels and creates heat to disable the nerves and potentially lower blood pressure. The purpose of this clinical study is to see whether a medical device called the Paradise Renal Denervation System (also called The Paradise System) can lower high blood pressure in patients who are known to have hypertension.
    Benzuly, Keith HBenzuly, Keith H
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03614260 STU00209790
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    Hypertension HTN
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    Right Ventricular Ischemia and Fibrosis in Chronic Thromboembolic Pulmonary Hypertension (CTEPH)

    This study is enrolling patients who have been diagnosed with chronic thromboembolic pulmonary hypertension (CTEPH) and who are scheduled for a pulmonary endareterectomy (PEA) or balloon pulmonary angioplasty (BPA) procedure for treatment. CTEPH is high blood pressure in the arteries in the pulmonary system (lungs) caused by clots. Over time …
    This study is enrolling patients who have been diagnosed with chronic thromboembolic pulmonary hypertension (CTEPH) and who are scheduled for a pulmonary endareterectomy (PEA) or balloon pulmonary angioplasty (BPA) procedure for treatment. CTEPH is high blood pressure in the arteries in the pulmonary system (lungs) caused by clots. Over time the clots typically leave scar tissue (fibrosis) in the arteries and lead to poor blood supply to the heart. In patients with CTEPH symptoms of heart failure commonly result from dysfunction (not working correctly) in the right ventricle (RV), or the chamber of the heart that pumps blood to the lungs. However, little is currently known about why or how that chamber of the heart becomes dysfunctional in patients with this condition. In another chamber of the heart, the left ventricle, it is known that elevated blood pressure in that chamber causes the development of diffuse fibrosis, or scarring between the muscle fibers, and a similar process may take place in the right ventricle of patients with CTEPH.

    For this study a cardiac magnetic resonance imaging (MRI) stress test (also known as stress CMR) will be done to look at the RV in patients with CTEPH before and 6 months after treatment. A stress CMR is a specialized scan of the heart that examines fibrosis (scarring) and blood flow (perfusion) both at rest and under stress. A gadolinium contrast agent (MRI dye) is given to highlight the heart muscle in areas receiving a good blood supply. Areas receiving less blood do not highlight as well as the good areas, which can be an indicator of ischemic heart disease (undersupply of blood and oxygen to the heart).

    Freed, Benjamin HowardFreed, Benjamin Howard
    • Map it 201 East Huron Street Suite 12-160​
      Chicago, IL
    STU00210998
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    pHysiological signals, Activity and Posture for surface mounted Insertable Cardiac Monitor in Heart Failure (HAPI-HF) Study

    This study is enrolling patients to use a wearable insertable cardiac monitor to better understand the various sounds that the heart makes during cardiac tests. You are being asked to participate in this study because Boston Scientific Corporation (BSC) is making a device called the insertable cardiac monitor (ICM) that …
    This study is enrolling patients to use a wearable insertable cardiac monitor to better understand the various sounds that the heart makes during cardiac tests. You are being asked to participate in this study because Boston Scientific Corporation (BSC) is making a device called the insertable cardiac monitor (ICM) that measures certain heart functions. The device also works when it is placed on top of the chest. BSC made a more comfortable, wearable version of the device to use in this study. The wearable device is called the wearable cardiac monitor (WCM). As part of the study, the WCM will collect data during tests while taped to the skin. The tests include leg raise exercises, lying down, sitting and/or standing, and an optional submaximal exercise test for participants the study doctor determines appropriate. There may also be an echocardiogram during these tests. An echocardiogram takes pictures of the heart using sounds waves created by the heart. The purpose of this study is to collect data during a series of tests to see if the WCM can detect signals related to heart failure. This data will be compared to the data obtained by the echocardiogram.
    Shah, Sanjiv JShah, Sanjiv J
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04112576 STU00210829
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    Percutaneous MitraClipTM Device or Surgical Mitral Valve REpair in PAtients with PrImaRy Mitral Regurgitation who are Candidates for Surgery (REPAIR MR)

    The purpose of this research study is to compare health outcomes of patients diagnosed with Primary MR who have their MV repaired with open heart surgery, which is the current standard treatment, to patients who have their Mitral Valve repaired with the MitraClip System. The MitraClip System uses a less …
    The purpose of this research study is to compare health outcomes of patients diagnosed with Primary MR who have their MV repaired with open heart surgery, which is the current standard treatment, to patients who have their Mitral Valve repaired with the MitraClip System. The MitraClip System uses a less invasive procedure to repair the mitral valve.

    Subjects are asked to participate in this Study because they have moderate-to-severe or severe MR and it has been determined to have symptoms due to heart failure despite being treated with currently available therapies. MR occurs when the leaflets of the mitral valve do not close properly causing blood to leak backward with each heartbeat. Since some of the blood leaks backward, the heart needs to pump more blood with each beat to push the same amount of blood forward.

    The Study will enroll approximately 500 subjects at up to 60 sites in Europe, United States, and Canada. The Study consists of two arms: Device Arm and Control Arm.

    • Subject has severe (Grade III or greater per the ASE criteria, which includes severitygrades of 3+ and 4+) primary MR (mixed etiology is acceptable provided theprincipal mechanism of action is a degenerative mitral valve) as assessed bythe ECL.
    • Subject is at least 75 years of age

    Davidson, Charles JDavidson, Charles J
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04198870 STU00211557
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    Clinical Trial to Evaluate Cardiovascular Outcomes in Patients Treated with the Tricuspid Valve Repair System Pivotal (TRILUMINATE Pivotal)

    The purpose of this research study is to compare the safety and effectiveness of an investigational tricuspid valve repair system, called TriClip TM Device, which is inserted into the heart, along with using optimal drug therapy for your heart condition versus optimal drug therapy alone. The Study will enroll approximately …
    The purpose of this research study is to compare the safety and effectiveness of an investigational tricuspid valve repair system, called TriClip TM Device, which is inserted into the heart, along with using optimal drug therapy for your heart condition versus optimal drug therapy alone. The Study will enroll approximately 700 subjects at up to 80 sites in Europe, United States and Canada. Up to 50 participants will be enrolled at Northwestern. The Study is made up of three different groups: Randomized (up to 450), Roll-In (up to 150, and Single-Arm Registry (up to 100).
    • Age ≥18 years at time of consent.
    • Subject has been diagnosed with moderate or greater tricuspid regurgitation determined to have symptoms due to heart failure despite being treated with currently available therapies
    Davidson, Charles JDavidson, Charles J
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03904147 STU00210487
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    A Multi-Center, Randomized, Double-blind, Placebo-controlled, Dose-finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CK­3773274 in Adults with Symptomatic Hypertrophic Cardiomyopathy

    This study is enrolling patients who have obstructive hypertrophic cardiomyopathy (oHCM). Obstructive HCM is a condition in which the heart muscle in the left ventricle (LV) becomes abnormally thickened, which can block blood flow out of the heart to the body. This obstruction causes the LV heart muscle to work …
    This study is enrolling patients who have obstructive hypertrophic cardiomyopathy (oHCM). Obstructive HCM is a condition in which the heart muscle in the left ventricle (LV) becomes abnormally thickened, which can block blood flow out of the heart to the body. This obstruction causes the LV heart muscle to work harder to pump blood to the body and can cause symptoms of chest pain, dizziness, shortness of breath and fainting. This is the first time the investigational drug called CK-3773274 is being studied in participants who have oHCM, but it has already been studied in healthy volunteers. The purpose of this study is to learn how well CK-3773274 is tolerated at different, increasing dose levels in patients with oHCM and if it causes any side effects. The study will also measure the amount of CK-3773274 in your blood at various times, and the effect the study drug may have on your oHCM. CK-3773274 is an investigational (experimental) study drug. This means that CK-3773274 has not been approved by the U.S. Food and Drug Administration (FDA) for use outside of a research study.
    Choudhury, LubnaChoudhury, Lubna
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04219826 STU00211491
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    A Phase 3 Global, Double-Blind, Randomized, Placebo‑Controlled Study to Evaluate the Efficacy and Safety of ION-682884 in Patients with Transthyretin‑Mediated Amyloid Cardiomyopathy (ATTR CM)

    This study is enrolling patients who have transthyretin-mediated amyloid cardiomyopathy (ATTR-CM) which is a disease caused by change in a protein called transthyretin (TTR). This change can either be sporadic which is known as wild-type (wtATTR-CM) or due to a mutation of the TTR gene which …
    This study is enrolling patients who have transthyretin-mediated amyloid cardiomyopathy (ATTR-CM) which is a disease caused by change in a protein called transthyretin (TTR). This change can either be sporadic which is known as wild-type (wtATTR-CM) or due to a mutation of the TTR gene which is hereditary (hATTR-CM). In both cases, these changes can cause the TTR to clump and build up in certain parts of the body such as the nervous system, stomach, intestines, and heart. This build up is called an amyloid deposit. Amyloid deposits can sometimes cause heart disease or neuropathy (nerve damage). When amyloid is deposited into the heart, it can result in a condition referred to as cardiomyopathy. ION-682884 is an investigational drug. “Investigational” means that ION-682884 is not yet approved for use in any settings outside of clinical research studies like this one and is considered experimental. ION-682884 reduces the level of TTR in the blood of animals and healthy volunteers tested to date. Reducing the amount of TTR in the blood may reduce the amount of amyloid deposits in the body and may keep cardiomyopathy from getting worse over time. However, it is not known if ION-682884 will help cardiomyopathy. The purpose of this study is to evaluate the safety of ION-682884 and determine if it can help people with this type of cardiomyopathy.
    Shah, Sanjiv JShah, Sanjiv J
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04136171 STU00211443
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    Targeting Inflammation and Alloimmunity in Heart Transplant Recipients with Tocilizumab

    This study is enrolling patients who are about to have a heart transplant. After transplantation, or any other major surgery, there will be inflammation in the body. This inflammation can contribute to rejection of the transplanted heart. In addition, the immune system (your body’s defenses to protect against disease) …

    This study is enrolling patients who are about to have a heart transplant. After transplantation, or any other major surgery, there will be inflammation in the body. This inflammation can contribute to rejection of the transplanted heart. In addition, the immune system (your body’s defenses to protect against disease) will be activated by the presence of the new heart. Investigators believe that a drug called tocilizumab (ACTEMRA®) might reduce or prevent inflammation and reduce the immune system’s response to the new heart, and that this would improve the long-term health of your new heart. The purpose of this research study is to see if a study drug called Actemra® (tocilizumab) will, when given with standard anti-rejection medicines, lead to better heart transplantation outcomes at 1 year after the transplant. Tocilizumab is a prescription medicine approved by the US Food and Drug Administration (FDA) to treat rheumatoid arthritis (RA) and other inflammatory diseases. Tocilizumab has not been used before to treat people who receive a heart transplant. We don’t know if it will be good for people who have a heart transplant. Tocilizumab is not approved by the FDA to treat heart transplant patients, and therefore using it in this study is considered investigational.

    Ghafourian, KambizGhafourian, Kambiz
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03644667 STU00212222
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    Edwards EVOQUE Transcatheter Tricuspid Valve Replacement: Pivotal Clinical Investigation of Safety and Clinical Efficacy using a Novel Device

    This study is recruiting patients with Tricuspid Regurgitation (TR), a condition in which the heart’s tricuspid valve does not close tightly which causes the blood to flow in the wrong direction during part of the cardiac cycle (heart beat). This condition increases the workload on the heart and if …
    This study is recruiting patients with Tricuspid Regurgitation (TR), a condition in which the heart’s tricuspid valve does not close tightly which causes the blood to flow in the wrong direction during part of the cardiac cycle (heart beat). This condition increases the workload on the heart and if left untreated, it can increase the risk of worsening heart failure. The goal of this trial is to evaluate the safety and effectiveness of the Study Device with Optimal Medical Therapy (OMT) compared to OMT alone in the study of subjects with severe or greater tricuspid regurgitation.
    Davidson, Charles JDavidson, Charles J
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04482062 STU00213338
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    (xIRB) DEFINE AFib

    This study is recruiting patients who have a Medtronic Reveal LINQ or LINQ II (or other market-released model) Insertable Cardiac Monitor (ICM) device to monitor their Atrial Fibrillation (Afib).  The study will be collecting data entered from the Medtronic Discovery App, data from the LINQ ICM device, and, …
    This study is recruiting patients who have a Medtronic Reveal LINQ or LINQ II (or other market-released model) Insertable Cardiac Monitor (ICM) device to monitor their Atrial Fibrillation (Afib).  The study will be collecting data entered from the Medtronic Discovery App, data from the LINQ ICM device, and, if allowed, data from the Apple Health app on your iPhone.  The purpose of this study is to both better understand how certain factors affect patterns of Afib; and how each patient's Afib impacts their daily life, quality of life, Afib symptoms, and healthcare usage.  
    Patil, Kaustubha DilipPatil, Kaustubha Dilip
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00214493
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    AN EXPLORATORY, OPEN-LABEL, PROOF-OF-CONCEPT, PHASE 2A STUDY OF MAVACAMTEN (MYK-461) IN PARTICIPANTS WITH HEART FAILURE WITH PRESERVED EJECTION FRACTION (HFpEF) AND CHRONIC ELEVATION OF CARDIAC BIOMARKERS

    This study is recruiting patients who have been diagnosed with Heart Failure with Preserved Ejection Fraction. The study will test whether a drug called mavacamten can lower blood levels of cardiac troponin (a marker of heart muscle injury) and/or NT-proBNP (a marker of heart wall stress). These “biomarkers” …
    This study is recruiting patients who have been diagnosed with Heart Failure with Preserved Ejection Fraction. The study will test whether a drug called mavacamten can lower blood levels of cardiac troponin (a marker of heart muscle injury) and/or NT-proBNP (a marker of heart wall stress). These “biomarkers” are increased in the blood of some people with HFpEF. Additionally, the main research study will provide preliminary information regarding tolerability and safety of mavacamten treatment in HFpEF. Mavacamten is an investigational drug. This means that it has not been approved by the Food and Drug Administration (FDA) or any regulatory agency for routine clinical use, including the treatment of HFpEF.
    Patel, Ravi BPatel, Ravi B
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04766892 STU00213899
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    An Open-Label, Exploratory Study of the Safety and Preliminary Efficacy of Danicamtiv in Stable Ambulatory Patients with Primary Dilated Cardiomyopathy due to either MYH7 or TTN Variants

    This study is recruiting patients aged 18-80 years and who have been diagnosed with dilated cardiomyopathy due to a mutation in either MYH7 or TTN, both of which are genes involved in the function of heart muscle. The purpose of Part A of this study is to evaluate the …
    This study is recruiting patients aged 18-80 years and who have been diagnosed with dilated cardiomyopathy due to a mutation in either MYH7 or TTN, both of which are genes involved in the function of heart muscle. The purpose of Part A of this study is to evaluate the safety, tolerability, and cardiac pharmacodynamics (the effect of the drug on your heart) of the study drug, danicamtiv, when administered by mouth twice a day for approximately one to two weeks. Once you complete Part A of the study, you will have the option to continue onto Part B of the study and receive study drug for approximately another 96 weeks.

    Danicamtiv is being developed to improve the pumping function of the heart muscle for subjects with large hearts that do not pump blood as well as normal hearts, known as dilated cardiomyopathy, and heart failure with reduced ejection fraction (the heart cannot pump enough blood to meet the body's needs).

    Wilcox, Jane EWilcox, Jane E
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04572893 STU00214902
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    A Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of IMB-1018972 in Patients with Non-obstructive Hypertrophic Cardiomyopathy

    This study is recruiting patients with a diagnosis of hypertrophic cardiomyopathy (HCM) who are able to perform a treadmill cardiopulmonary exercise test.  The safety and tolerability of investigative study drug IMB-1018972 is being studied in patients with non-obstructive hypertrophic cardiomyopathy. This study will also exmaine the effect …
    This study is recruiting patients with a diagnosis of hypertrophic cardiomyopathy (HCM) who are able to perform a treadmill cardiopulmonary exercise test.  The safety and tolerability of investigative study drug IMB-1018972 is being studied in patients with non-obstructive hypertrophic cardiomyopathy. This study will also exmaine the effect of IMB-1018972 on exercise capacity and how the heart uses energy.
    Choudhury, LubnaChoudhury, Lubna
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04826185 STU00215049
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    Impella®-Supported PCI in High-Risk Patients with Complex Coronary Artery Disease and Reduced Left Ventricular Function: The PROTECT IV Trial

    This study is recruiting patients who are scheduled to have a heart procedure called a Percutaneous Coronary Intervention (PCI) and may be at risk of potential problems during the procedure because they have complex heart disease and reduced left heart function.  The purpose of this study is to assess …
    This study is recruiting patients who are scheduled to have a heart procedure called a Percutaneous Coronary Intervention (PCI) and may be at risk of potential problems during the procedure because they have complex heart disease and reduced left heart function.  The purpose of this study is to assess if using an Impella device during high-risk PCI in patients with reduced left-sided heart function will result in an improvement in symptoms, heart function, and health after the heart procedure compared to the current standard of care.  
    Benzuly, Keith HBenzuly, Keith H
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04763200 STU00214880
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    Randomized Clinical Evaluation of the AccuCinch® Ventricular Restoration System in Patients who Present with Symptomatic Heart Failure with Reduced Ejection Fraction (HFrEF)

    The purpose of this study is to assess the safety and effectiveness of the AccuCinch Ventricular Restoration System and compare it to standardized heart failure medications.  The AccuCinch Ventricular Restoration System is an investigational (experimental) device intended to treat patients who are experiencing symptoms of heart failure due to …
    The purpose of this study is to assess the safety and effectiveness of the AccuCinch Ventricular Restoration System and compare it to standardized heart failure medications.  The AccuCinch Ventricular Restoration System is an investigational (experimental) device intended to treat patients who are experiencing symptoms of heart failure due to a dilated (enlarged) left ventricle (heart chamber which pumps blood).   
    Flaherty, James DFlaherty, James D
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04331769 STU00214441
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    LUX-Dx Heart Failure Sensors in an Insertable Cardiac Monitor System Clinical Study

    This study is recruiting patients whose medical tests show they have heart failure, and whose doctors have determined that they would benefit from an insertable cardiac monitor (ICM).  Heart Failure is a condition that makes the heart muscle weak and the heart cannot pump as much blood as the …
    This study is recruiting patients whose medical tests show they have heart failure, and whose doctors have determined that they would benefit from an insertable cardiac monitor (ICM).  Heart Failure is a condition that makes the heart muscle weak and the heart cannot pump as much blood as the body needs.  Sensors have been added to the ICM to determine whether they can provide doctors who treat patients with similar conditions with additional information to help analyze their heart failure condition.  The study will gather information about the sensors.  
    Okwuosa, Ike StanleyOkwuosa, Ike Stanley
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04790344 STU00214908
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    A Randomised, Double-blind, Placebo-controlled, Multi-center Sequential Phase 2b and Phase 3 Study to Evaluate the Efficacy and Safety of AZD4831 Administered for up to 48 Weeks in Participants with Heart Failure With Left Ventricular Ejection Fraction > 40%

    Study to evaluate the efficacy and safety of AZD4831 in patients with heart failure with preserved ejection fraction…
    Study to evaluate the efficacy and safety of AZD4831 in patients with heart failure with preserved ejection fraction
    • Heart Failure with Preserved Ejection Fraction
    • Participant Age ≥40 to ≤85
    Patel, Ravi BPatel, Ravi B
    • Map it 675 N. Saint Clair St. Nineteenth Floor, Suite 100
      Chicago, IL
    NCT04986202 STU00215147
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    HFpEF AZD4831
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    Mediators of Atherosclerosis in South Asians Living in America

    South Asian (Indian, Pakistani, Bangladeshi, Nepali, and Sri Lankan) individuals have high rates of cardiovascular disease that is not explained by traditional cardiovascular risk factors. Though South Asians represent over one-quarter of the world's population, there are no longitudinal studies in this high-risk ethnic group. The investigators aim to establish a longitudinal study of South Asians at two United States centers to identify risk factors linked to subclinical atherosclerosis and incident cardiovascular disease. The purpose of this study is to understand the causes of heart disease and stroke in South Asians and compare these causes to those in other United States ethnic groups.
    Kandula, Namratha RKandula, Namratha R
    NCT01207167 STU00019837
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    Low InTensity Exercise intervention in PAD: The LITE Trial.

    This study is being done to determine whether an exercise intervention that avoids continuous supervision and exercise-related pain in the legs can improve walking ability in people with lower extremity peripheral artery disease (PAD).
    Peripheral artery disease
    McDermott, Mary McGraeMcDermott, Mary McGrae
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02538900 STU00105855
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    Telmisartan Plus Exercise to Improve Functioning in PAD

    The purpose of this study is to establish whether the angiotensin receptor blocker (ARB) telmisartan improves walking performance in people with PAD. We will also determine whether telmisartan plus supervised exercise improves walking performance more than telmisartan alone and more than supervised treadmill exercise alone. …
    The purpose of this study is to establish whether the angiotensin receptor blocker (ARB) telmisartan improves walking performance in people with PAD. We will also determine whether telmisartan plus supervised exercise improves walking performance more than telmisartan alone and more than supervised treadmill exercise alone.
    We are asking you to take part in this research study because you have or may have peripheral artery disease (PAD). PAD is a condition in which cholesterol blockages in the leg arteries prevent blood from getting down to the legs and feet during exercise.
    McDermott, Mary McGraeMcDermott, Mary McGrae
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02593110 STU00200954
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    Improving Outpatient Safety of Older Adults through Electronic Patient Portals

    The objective of this study is to assess whether providing caregivers of older adults proxy access to an electronic patient portal (MyChart) improves the outpatient medication safety and communication between caregivers and health care providers. …
    The objective of this study is to assess whether providing caregivers of older adults proxy access to an electronic patient portal (MyChart) improves the outpatient medication safety and communication between caregivers and health care providers.
    Adults age 65 and older, a patient in the General Internal Medicine and Geriatrics (NMFF GIM-GER) clinics, not currently enrolled in MyChart Electronic Patient Portal, English speaking, can identify a caregiver who assists with their care (can be informal e.g. adult child, spouse, caregiver agency). Additional eligibility criteria are focused on the caregiver identified: English speaking, assist the older adult with medications and communication with the health care team, and have internet access (either phone, tablet, or laptop/computer).
    Lindquist, Lee ALindquist, Lee A
    • Map it 675 N. St. Clair St.
      Chicago, IL
    STU00201242
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    The ENabling Reduction of low-Grade Inflammation in SEniors) Pilot Study

    The purpose of the ENRGISE Pilot Study is to look at the effect of anti-inflammatory drugs on physical functioning in older adults. This study will see if two study drugs (fish oil and losartan, a commonly used blood pressure medicine) have an effect on walking ability.…
    The purpose of the ENRGISE Pilot Study is to look at the effect of anti-inflammatory drugs on physical functioning in older adults. This study will see if two study drugs (fish oil and losartan, a commonly used blood pressure medicine) have an effect on walking ability.
    Age 70 or older, slow walking speed, and high levels of markers of inflammation in your blood.
    McDermott, Mary McGraeMcDermott, Mary McGrae
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02676466 STU00201974
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    Cocoa to Improve Walking Performance in Peripheral Artery Disease: The COCOA-PAD Study

    The purpose of this study is to determine whether drinking daily cocoa-enriched beverages improves walking performance in people with PAD. Previous studies have shown that cocoa may improve blood flow, improve cardiovascular health, and improve muscle function and strength. Some evidence suggests that cocoa may also improve walking ability …
    The purpose of this study is to determine whether drinking daily cocoa-enriched beverages improves walking performance in people with PAD. Previous studies have shown that cocoa may improve blood flow, improve cardiovascular health, and improve muscle function and strength. Some evidence suggests that cocoa may also improve walking ability in people with PAD.
    We are asking you to take part in this research study because you are age 65 or older and you have or may have peripheral artery disease (PAD). PAD is a condition in which cholesterol blockages in the leg arteries prevent adequate blood flow to the legs and feet.
    McDermott, Mary McGraeMcDermott, Mary McGrae
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02876887 STU00202741
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    Reducing Assessment Barriers for Patients with Low Literacy

    This study aims to learn whether routine health questionnaires are valid across groups of people who have different levels of understanding of basic health information.
    You may be eligible for this study if you are the age of 18 or older, are fluent in English and/or Spanish, have no plans to move outside of the Chicagoland area in the next 6 months, and are willing to complete questionnaires on an electronic tablet or in paper & pencil format. You will be asked to complete 3 face-to-face interviews at Northwestern in downtown Chicago and will be compensated for your time and transportation.
    Griffith, James WGriffith, James W
    NCT03584490 STU00204308
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    NU 05H6: Acute Leukemias and Map Kinase

    Normally, white blood cells are produced in a controlled way by the bone marrow. In someone with AML or ALL, this production process is abnormal and immature cells are produced and sent into the blood stream. In this immature state, the cells affect the production of other normal cells and …

    Normally, white blood cells are produced in a controlled way by the bone marrow. In someone with AML or ALL, this production process is abnormal and immature cells are produced and sent into the blood stream. In this immature state, the cells affect the production of other normal cells and these cannot perform their usual functions. Therefore patients with AML or ALL are vulnerable to infection, anemia, and bleeding.

    The purpose of this study is to understand what causes the white blood cells to grow abnormally, and to determine if there are novel agents that can be used to stop this abnormal growth. In this research project, a sample of blood and bone marrow will be studied in the laboratory to learn more about the nature of the disease, and to understand what causes the defect in the growth of these cells.

    You may be eligible for this research study if you have been diagnosed with acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL), which are cancers of the blood that affect white blood cells.

    Platanias, Leonidas CPlatanias, Leonidas C
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00004841
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    NCI 02X3: SPORE in Pancreatic Cancer Tissue Core

    The purpose of this research study is to examine many aspects of gastrointestinal disease including pancreatic and colon cancer, including its genetics, its early stages, and the effects of cancer on other tissues such as muscle and adipose (fat) tissue. Tissues from patients (with cancer as well as from those …

    The purpose of this research study is to examine many aspects of gastrointestinal disease including pancreatic and colon cancer, including its genetics, its early stages, and the effects of cancer on other tissues such as muscle and adipose (fat) tissue. Tissues from patients (with cancer as well as from those without), who are undergoing pancreatic surgery, will be used in this research.

    You may be eligible for this research study if you are visiting the high risk clinic and/or are undergoing surgery to remove a portion of your pancreas.

    Yang, Guang-YuYang, Guang-Yu
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00007180
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    NU 04H7: Molecular Mechanisms of Disease Progression in Myeloid Malignancy

    In this research project, samples of blood and bone marrow will be studied in the laboratory to learn more about the nature of chronic myelogenous leukemia (CML) cells and how various medications and chemical agents affect them.The purpose of this study is to learn about how CML leukemia cells …

    In this research project, samples of blood and bone marrow will be studied in the laboratory to learn more about the nature of chronic myelogenous leukemia (CML) cells and how various medications and chemical agents affect them.

    The purpose of this study is to learn about how CML leukemia cells become resistant to medications or progress to acute leukemia (blast crisis). This may prove to be helpful in the design of new more effective drugs for the treatment of CML in the future.

    You may be eligible to take part in this research study if you have been diagnosed with chronic myelogenous leukemia (CML), a chronic form of leukemia, OR if you are a normal individual without any blood disorders.

    Eklund, Elizabeth AEklund, Elizabeth A
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00039629
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    NCI 12H13: Molecular Mechanisms of Relapse After Therapy Discontinuation in Chronic Myeloid Leukemia

    In this research study, samples of bone marrow or peripheral blood will be collected from patients with chronic myeloid leukemia (CML) to learn more about the effect of some new drugs on CML cells in the laboratory. The purpose of this study is to understand how these new drugs stop …

    In this research study, samples of bone marrow or peripheral blood will be collected from patients with chronic myeloid leukemia (CML) to learn more about the effect of some new drugs on CML cells in the laboratory. The purpose of this study is to understand how these new drugs stop leukemia cells from growing. This research may prove to be helpful in the design of new and more effective treatments for leukemia in the future.

    You may be eligible for this research study if you have been diagnosed with chronic myeloid leukemia, a cancer of the blood and are scheduled to have a bone marrow biopsy.

    Eklund, Elizabeth AEklund, Elizabeth A
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00074258
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    NUDB 13C03: Northwestern Brain Tumor Institute Research Database

    The Northwestern Brain Tumor Institute (NBTI) currently uses an electronic database to collect and store information about patients who come to the NBTI for evaluations, including diagnosis, treatment, follow-up, and/or to obtain additional opinions. This database is called the Northwestern Brain Tumor Institute Database or NBTIDB, and it …

    The Northwestern Brain Tumor Institute (NBTI) currently uses an electronic database to collect and store information about patients who come to the NBTI for evaluations, including diagnosis, treatment, follow-up, and/or to obtain additional opinions. This database is called the Northwestern Brain Tumor Institute Database or NBTIDB, and it was developed to replace older paper methods for collecting and storing information.

    The purpose of this study is to allow researchers involved with the NBTIDB to use data stored in it for future research studies and projects. The NBTIDB also allows researchers to track whether or not patients have agreed to allow their information to be linked to their leftover tissue samples, which are kept in the hospital’s pathology department, for future research studies.

    You may be eligible to take part in the research component of the NBTIDB if you are either a new or returning patient, over the age of 18, who is being seen by one of the clinicians at the NBTI and are or will be entered into the NBTIDB, or a patient who is not coming to the NBTI for evaluation, but would still like to participate in the NBTIDB.

    Kumthekar, Priya UKumthekar, Priya U
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00087359
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    NCI 15H01: Triad1 Regulates Myelopoiesis and Functions as a Leukemia Suppressor

    Researchers have found that about 60% of patients with acute myeloid leukemia (AML) will obtain a remission following treatment with combinations of chemotherapy drugs. However, relapse after treatment remains a problem, and can be as high as 80% in some types of AML patients. Therefore, it would be beneficial to …

    Researchers have found that about 60% of patients with acute myeloid leukemia (AML) will obtain a remission following treatment with combinations of chemotherapy drugs. However, relapse after treatment remains a problem, and can be as high as 80% in some types of AML patients. Therefore, it would be beneficial to identify specific treatment approaches for patients at a high risk for relapse. One characteristic associated with high relapse rates is an increase in proteins that are referred to as Hox proteins in the leukemia cells. Increase in Hox proteins prevents production of some other proteins, including a protein referred to as Triad1. An increase in Triad1 protein in bone marrow cells may be important to control the growth of such cells. Decreased Triad1 in leukemia cells may therefore promote their growth, but this has not been previously studied.

    The purpose of this study is to investigate if the lack of Triad1 in leukemia cells contributes to resistance of some leukemias to chemotherapy drugs. This research may prove to be helpful in the design of new and more effective treatments for leukemia in the future.

    At a time when you are having a bone marrow biopsy and aspirate performed as part of your standard medical care, about an additional 2.5 teaspoons (12.5 mL) of bone marrow will be collected for this research study.

    You may be eligible for this research study if you have been diagnosed with acute myeloid leukemia (AML), a cancer of the blood.

    Eklund, Elizabeth AEklund, Elizabeth A
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00200435
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    NU 15N01: Head and Neck Tissue Bank

    Researchers would like to create a bio-specimen bank of tissue, blood, urine and saliva, which would then be used to study cancer and find better ways to detect, prevent, diagnose, treat and provide better care for future patients. Some of these studies may be about how genes affect the …

    Researchers would like to create a bio-specimen bank of tissue, blood, urine and saliva, which would then be used to study cancer and find better ways to detect, prevent, diagnose, treat and provide better care for future patients. Some of these studies may be about how genes affect the development of cancer, response or resistance to treatment as well as prognosis (course of disease and overall outcome including survival). Other studies may aim to identify measurable substances in the blood and/or urine (known as biomarkers) that can indicate early development of cancer, worsening or relapse of disease and response to treatment. Some studies may lead to new products, such as drugs or tests for detection of cancer.

    You may be eligible to take part in our head and neck specimen banking study if you have one of the following conditions:

    a) You have a tumor or an abnormal area in the head and neck area, suspicious for cancer, or pre-cancerous condition or other pathology of interest, and you’re scheduled to have biopsy and/or surgery at Northwestern Memorial Hospital.

    b) You will receive treatment and/or regular follow up for further management for your head and neck cancer or precancerous condition, or other pathology at Northwestern Memorial Hospital and/or Northwestern Medicine Developmental Therapeutics Institute (NMDTI).

    Samant, SandeepSamant, Sandeep
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00202177
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    NU 15N02: Northwestern Head and Neck Cancer Registry

    The purpose of this registry is to collect clinical information on all consenting head and neck cancer patients seen at the Northwestern Medical Group (NMG) or Northwestern Memorial Hospital (NMH). With this information, researchers will conduct studies to learn more about the subtypes of head and neck cancers and determine …

    The purpose of this registry is to collect clinical information on all consenting head and neck cancer patients seen at the Northwestern Medical Group (NMG) or Northwestern Memorial Hospital (NMH). With this information, researchers will conduct studies to learn more about the subtypes of head and neck cancers and determine the most effective treatments. The registry will also allow us to identify possible subjects for future studies.

    You may be eligible to take part in this research study if you are being treated or have been treated for a tumor or cancer of the head and neck.

    Samant, SandeepSamant, Sandeep
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00202162
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    NU 16B06: Investigation of Blood-Based Prognostic Biomarkers in Patients with Advanced Breast Cancer for Molecular Mechanisms Underlying Circulating Tumor Cell Clusters

    This study is being done to help improve the knowledge on the biology of breast cancer in the future. Blood specimens from patients with breast cancer will be collected and utilized for future research projects known as biomarker studies. These blood based laboratory tests will ultimately evaluate molecules present in …

    This study is being done to help improve the knowledge on the biology of breast cancer in the future. Blood specimens from patients with breast cancer will be collected and utilized for future research projects known as biomarker studies. These blood based laboratory tests will ultimately evaluate molecules present in the blood of patients with breast cancer. These molecules could be, for example, a protein, tumor DNA, or tumor cells circulating in the blood. As research technology advances, blood samples from patients with breast cancer may help in understanding the course of disease and to check as to how effective a treatment is.

    You may be eligible for this research study if you have advanced stage (III/IV)breast cancer.

    Shah, Ami NShah, Ami N
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00203283
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    NUDB 16Z01: The OncoSET Program Database and Biobank - Combining Clinical Outcomes with Next Generation Sequencing and other Advanced Molecular Testing for Genetic Aberrations in Patients with Advanced Solid Malignancies

    The purpose of the study is to gather information about your cancer and the treatment you receive as a part of your routine clinical care. In this study, we are developing a research registry, which is a bank of information about many patients.We are interested in learning about the …

    The purpose of the study is to gather information about your cancer and the treatment you receive as a part of your routine clinical care. In this study, we are developing a research registry, which is a bank of information about many patients.

    We are interested in learning about the relationship between your cancer and the different types of tests available to identify the best treatment option for you. That is, we are interested in the tests that identify possible ‘mutations’ (e.g., changes) or ‘drivers’ within your tumor, what treatments you receive after getting these tests, and how your cancer responds to the treatments.

    The tests known as next generation sequencing or “NGS” are usually done on your cancer tissue or blood samples as a part of your routine clinical care. Your doctor can use the information to identify the best treatment option for you after discussing it with other doctors. These routine tests will be performed whether you participate in this study or not, but we want to collect the information about this process for this study.

    If you participate in this study, extra samples of your blood will be collected and stored, and your health information from your medical record and NGS lab results will be collected and stored.

    You may be eligible for this research study if you have a diagnosis of cancer and are being treated at the Robert H. Lurie Comprehensive Cancer Center of Northwestern University.

    VanderWeele, David JamesVanderWeele, David James
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00203944
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    Melanoma and Skin Cancer Tissue Repository

    The purpose of this study is to allow researchers studying and treating melanoma and other cancers to have access to tissue for research purposes only. Northwestern University may use your medical record information, as well as tumor, blood, saliva, urine, and fecal samples (collectively called “tissue”) for research studies to …

    The purpose of this study is to allow researchers studying and treating melanoma and other cancers to have access to tissue for research purposes only. Northwestern University may use your medical record information, as well as tumor, blood, saliva, urine, and fecal samples (collectively called “tissue”) for research studies to help us understand melanoma and other skin cancers. Biopsies and surgery of your cancer will not be a part of this study but will be performed as part of your standard care.

    You may be eligible to take part in the research component of the Northwestern Melanoma and Skin Cancer Tissue Repository if you are either a new or returning patient and have a skin cancer or pre-cancer lesion.

    Sosman, Jeffrey AlanSosman, Jeffrey Alan
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00204151
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    PET/MRI using [18F]-DCFPyL for the Staging of Newly Diagnosed Prostate Cancer

    This research study involves the use of a scanner that is capable of taking PET and MR images at the same time. A PET scan is a test that uses radioactive glucose (sugar) and a computer to create images of how organs and tissues in the body are functioning. Abnormal …
    This research study involves the use of a scanner that is capable of taking PET and MR images at the same time. A PET scan is a test that uses radioactive glucose (sugar) and a computer to create images of how organs and tissues in the body are functioning. Abnormal cells in the body use glucose at a different rate than normal cells and this allows the scanner to create a detailed picture of how your body is working. A MR scan uses strong magnets and computers to created detailed images of the soft tissue in your body. The purpose of this study is to gain understanding how PET-MR (positron emission tomography-magnetic resonance imaging) using the substance 18F-DCFPyL (PyL) may help in diagnosing prostate cancer and in determining the stage of prostate cancer before surgery.
    Men with biopsy-proven prostate cancer and a diagnosis of high risk, very high risk or locally advanced prostate cancer per NCCN guidelines.
    Schaeffer, Edward MatthewSchaeffer, Edward Matthew
    NCT03392181 STU00205957
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    (xIRB NCI CIRB) CCTG MA.39: TAILOR RT: A Randomized Trial Of Regional Radiotherapy In Biomarker Low Risk Node Positive Breast Cancer

    In addition to endocrine therapy and possibly chemotherapy, many women with node positive breast cancer will also receive radiotherapy to the whole breast/chest area and the surrounding lymph glands (called regional radiotherapy). Because no one really knows whether patients with low risk breast cancer need to receive regional radiotherapy, …
    In addition to endocrine therapy and possibly chemotherapy, many women with node positive breast cancer will also receive radiotherapy to the whole breast/chest area and the surrounding lymph glands (called regional radiotherapy). Because no one really knows whether patients with low risk breast cancer need to receive regional radiotherapy, it is possible that some women who get it may not actually need it. These women may be exposed to the side effects of their treatment without benefit. The purpose of this study is to learn if not giving regional radiotherapy is just as good as using regional radiotherapy by comparing any good and bad effects of both approaches. The study has two randomly assigned study groups; Group 1 will receive regional radiotherapy and Group 2 will not. 
    Patients who are of 40 years of age or older may be able to take part in this study if they have newly diagnosed breast cancer that has been treated with breast-conserving surgery or mastectomy and has not spread to other parts of the body.
    Donnelly, Eric DonaldDonnelly, Eric Donald
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03488693 STU00208897
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    (xIRB NCI CIRB) NRG GY012: A Randomized Phase II Study Comparing Single-Agent Olaparib, Single Agent Cediranib, and the Combinations of Cediranib/Olaparib, Olaparib/Durvalumab (MEDI4736), Cediranib/Durvalumab (MEDI4736), Olaparib/AZD5363 (Capivasertib) in Women with Recurrent, Persistent or Metastatic Endometrial Cancer. A Multi-Arm Trial for Women with Recurrent or Persistent Endometrial Cancer.

    This is a study to look at a different approach to treating endometrial cancer. It is being done to answer the following question: Can we lower the chance of your endometrial cancer growing or spreading by giving a combination of two experimental drugs or one experimental drug rather than the …

    This is a study to look at a different approach to treating endometrial cancer. It is being done to answer the following question: Can we lower the chance of your endometrial cancer growing or spreading by giving a combination of two experimental drugs or one experimental drug rather than the usual approach?

    The purpose of this study is to compare any good and bad effects of using experimental study drugs cediranib alone, olaparib alone, or a combination of cediranib and olaparib. These drugs could shrink your cancer but they could also cause side effects. This study will allow the researchers to know whether one of these approaches is better, the same, or worse than the usual approach. The usual approach is defined as care most people get for endometrial cancer.

    You may be eligible for this research study if you have endometrial cancer which has grown or has returned after earlier treatment.

    Matei, Daniela ElenaMatei, Daniela Elena
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03660826 STU00208995
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    (xIRB NCI) SWOG 1706: A Phase II Randomized Trial of Olaparib (NSC-747856) Administered Concurrently with Radiotherapy versus Radiotherapy Alone for Inflammatory Breast Cancer

    The purpose of this study is to determine if including thedrug olaparib taken along with radiation treatment decreases the recurrence of cancerin patients who have inflammatory breast cancer and have already hadchemotherapy and surgery to remove the cancer. The drug olaparib is already approved by the Food and DrugAdministration (FDA) …

    The purpose of this study is to determine if including thedrug olaparib taken along with radiation treatment decreases the recurrence of cancerin patients who have inflammatory breast cancer and have already hadchemotherapy and surgery to remove the cancer. The drug olaparib is already approved by the Food and DrugAdministration (FDA) for use in ovarian, fallopian tube, peritoneal cancer, andgBRCA mutated her2-negative metastatic breast cancer, however olaparib is notapproved for inflammatory breast cancer.

    inflammatory breast cancer who have already had chemotherapy and surgery to remove the cancer
    Donnelly, Eric DonaldDonnelly, Eric Donald
    • Map it 201 East Huron Street Suite 12-160​
      Chicago, IL
    NCT03598257 STU00209490
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    BTCRC HN17-111: Phase II trial of androgen deprivation therapy (ADT) and pembrolizumab for advanced stage androgen receptor-positive salivary gland carcinoma

    This study is being done to study two investigational drugs called pembrolizumab and goserelin to see if they shrink your cancer or stop it from growing. …
    This study is being done to study two investigational drugs called pembrolizumab and goserelin to see if they shrink your cancer or stop it from growing. 
    You may be eligible for this research study if you have salivary gland carcinoma that has grown or has come back after treatment.
    Boumber, YanisBoumber, Yanis
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03942653 STU00210435
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    (xIRB Sterling) DRUG 68284528MMY2003: A Phase 2, Multicohort Open-Label Study of JNJ-68284528, a Chimeric Antigen Receptor T cell (CAR-T) Therapy Directed Against BCMA in Subjects with Multiple Myeloma (CARTITUDE-2)

    The purpose of this study is to see if JNJ-68284528 is safe and useful for treating patients with relapsed or refractory multiple myeloma. In this type of treatment, your white blood cells (which are a part of the immune system) will be genetically modified to become JNJ-68284528 and …
    The purpose of this study is to see if JNJ-68284528 is safe and useful for treating patients with relapsed or refractory multiple myeloma. In this type of treatment, your white blood cells (which are a part of the immune system) will be genetically modified to become JNJ-68284528 and used to treat your multiple myeloma.

    Some of the eligibility criteria include:

    • Participants must have a diagnosis of multiple myeloma
    • Participants must be 18 or older.
    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.
    Singhal, SeemaSinghal, Seema
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04133636 STU00210994
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    (xIRB) NCI CIRB Alliance A021703: Randomized Double-blind Phase III Trial of Vitamin D3 Supplementation in Patients with Previously Untreated Metastatic Colorectal Cancer (SOLARIS)

    Participants with colorectal cancer will beinvited to participant in this study. The purpose of this study is to comparethe usual treatment (usual chemotherapy plus bevacizumab) plus high-dosevitamin D3 to using the usual treatment plus regular-dose vitamin D3. Thisstudy will help the study doctors find out if this different …

    Participants with colorectal cancer will beinvited to participant in this study. The purpose of this study is to comparethe usual treatment (usual chemotherapy plus bevacizumab) plus high-dosevitamin D3 to using the usual treatment plus regular-dose vitamin D3. Thisstudy will help the study doctors find out if this different approach isbetter, the same, or worse than the usual approach. To decide if it is better,the study doctors will be looking to see if the addition of high-dose vitaminD3 to usual approach can shrink or stabilize tumors for a longer period of timethan regular-dose vitamin D3 and usual approach.

    This study has two groups:

    Group 1: Participants in this group will getthe usual drug regimen used to treat this type of cancer, either FOLFOX plusbevacizumab or FOLFIRI plus bevacizumab, plus a study drug called high-dosevitamin D3.

    Group 2: Participants in this group you willget the usual drug regimen used to treat this type of cancer, either FOLFOXplus bevacizumab or FOLFIRI plus bevacizumab, plus a study drug calledregular-dose vitamin D3.

    Participants who are at least 18 years of age or older who have advanced colorectal cancer. 
    Kircher, Sheetal MehtaKircher, Sheetal Mehta
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04094688 STU00211478
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    (xIRB) NCI CIRB ECOG-ACRIN 2185: Comparing the Clinical Impact of Pancreatic Cyst Surveillance Programs

    The purpose of this study is tocompare the two approaches for monitoring pancreatic cysts. The doctors want tosee if less frequent monitoring is better or worse than more frequentmonitoring for patients with pancreatic cysts. This study has 2 study groups: Group 1Participants in this group willget less frequent monitoring. Participants …

    The purpose of this study is tocompare the two approaches for monitoring pancreatic cysts. The doctors want tosee if less frequent monitoring is better or worse than more frequentmonitoring for patients with pancreatic cysts.

    This study has 2 study groups:

    Group 1

    Participants in this group willget less frequent monitoring. Participants will receive an MRI or CT imagingscan at the beginning of the study and repeat the scan 1 year after joining thestudy. If the scans show normal results, scans will be repeated every 2 years.If the scans show abnormal results, participants will receive an endoscopicultrasound.

    Group 2

    Participants in this group willget more frequent monitoring. Participants will receive an MRI or CT imagingscan at the beginning of the study. . The frequency of repeat imaging couldrange from every 6 months to every 2 years, based on the size of theparticipant's pancreatic cyst.

    Participants will be enrolled forup to five years.

    Participants between the ages of 50and 75 who have pancreatic cysts will be enrolled into this study.

    Chawla, AkhilChawla, Akhil
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04239573 STU00213102
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    (xirb) DRUG 7465-CL-202 : An Open-label, Multicenter, Multicohort, Phase 2 Study to Evaluate Enfortumab Vedotin in Subjects with Previously Treated Locally Advanced or Metastatic Malignant Solid Tumors (EV-202)

    The goal of this study is to find out if enfortumab vedotin is effective and safe as a treatment for people with breast, lung, head and neck, gastric, gastroesophageal junction, or esophageal cancer. The study will look at how enfortumab vedotin acts in the body. Enfortumab vedotin is expected to …

    The goal of this study is to find out if enfortumab vedotin is effective and safe as a treatment for people with breast, lung, head and neck, gastric, gastroesophageal junction, or esophageal cancer. The study will look at how enfortumab vedotin acts in the body. Enfortumab vedotin is expected to work by attacking cells that have a protein called Nectin-4. Some, but not all, of the risks and benefits of the drug are known.

    You may be eligible to participate in this study if you have breast, lung, head and neck, gastric, gastroesophageal junction, or esophageal cancer; your cancer has spread to nearby tissues (locally advanced) or other areas of the body (metastatic); and you have also received previous anticancer therapy.

    Participants may withdraw at any time.

    Mulcahy, Mary FrancesMulcahy, Mary Frances
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04225117 STU00213246
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    Prospective Molecular Profiling To Guide Therapeutic Decision-making in Patients with Advanced Hepatocellular Cancer (HCC): An Insight to Next Generation Sequencing-Matched Systemic Therapy in Liver Cancer (PROTOLIGHT STUDY)

    Hepatocellular carcinoma (HCC) is the most common form of liver cancer, making up approximately 90% of all liver cancers. It is the fourth largest contributor to cancer-related deaths worldwide. HCC is considered to be a complex tumor. Despite recent drug approvals for HCC, it has become clear that only …

    Hepatocellular carcinoma (HCC) is the most common form of liver cancer, making up approximately 90% of all liver cancers. It is the fourth largest contributor to cancer-related deaths worldwide. HCC is considered to be a complex tumor. Despite recent drug approvals for HCC, it has become clear that only some populations of patients benefit from certain drugs. This leads researchers to suspect that treatment for HCC would be more effective if we could match specific characteristics of a patient’s tumor with a drug that targets them best. Genomic analysis using an FDA-approved method called Next Generation Sequencing (NGS) could be used to potentially help physicians make such treatment decisions. The purpose of this study is to see how long patients will benefit if genomic analysis of their tumors is used to recommend more targeted treatments for HCC from a number of FDA-approved drugs.

    Eligible participants are at least 18 years of age and have advanced hepatocellular cancer (HCC) or recurrent HCC for which they have not yet received systemic therapy for, and are are not candidates for resection, transplant or liver-directed therapies.
    Mahalingam, DevalingamMahalingam, Devalingam
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00212975
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    (xIRB) NCI CIRB ETCTN 10300: BLockade of PD-1 Added to Standard Therapy to Target Measurable Residual Disease in Acute Myeloid Leukemia 1 (BLAST MRD AML-1): A Randomized Phase 2 Study of the Anti-PD-1 Antibody Pembrolizumab in Combination with Conventional Intensive Chemotherapy as Frontline Therapy in Patients with Acute Myeloid Leukemia

    The purpose of this study is to compare theusual treatment alone to adding immune system activating therapy, Pembrolizumab(MK-3475), to the usual treatment. This study will help the study doctors findout if this different approach is better than the usual approach. To decide if it is better, the study …

    The purpose of this study is to compare theusual treatment alone to adding immune system activating therapy, Pembrolizumab(MK-3475), to the usual treatment. This study will help the study doctors findout if this different approach is better than the usual approach. To decide if it is better, the study doctorswill be looking to see if the addition of pembrolizumab results in fewerdetectable leukemia using new methods.

    Pembrolizumab (MK-3475), is already approvedby the FDA for use in several cancers, including advanced or metastaticsmall-cell and non-small cell lung cancer, melanoma, head and neck cancer,urothelial cancer, hepatocellular carcinoma, gastric cancer, among others. However, Pembrolizumab (MK-3475) is notapproved by the FDA or known to be safe for use in AML either alone or incombination with standard chemotherapy.

    This study has 2 study groups. You will be putinto a group by chance. You will have anequal chance of being in Group 1 or Group 2

    Group 1

    Participants in group 1 will get the usualstudy drugs, cytarabine on Days 1-7 and either daunorubicin or idarubicin onDays 1-3. If you have evidence ofresidual leukemia in the bone marrow at Day 14, you will receive a second roundof the first part of therapy (5+2 chemotherapy), which means cytarabine on Days1-5 and either daunorubicin or idarubicin on Days 1-2. If you have a complete remission after thefirst part of therapy, you will continue with the second part of therapy thatconsists of up to four cycles of high dose cytarabine. If you remain in complete remission aftersecond part of therapy, you will be monitored without further therapy for up to3 years. If you proceed with atransplant, you will forgo any remaining protocol-defined therapy.

    Group 2

    Participants in group 2 will get the usualstudy drugs, cytarabine on Days 1-7 and either daunorubicin or idarubicin onDays 1-3. If you have evidence ofresidual leukemia in the bone marrow at Day 14, you will receive second dose ofthe first part of therapy (5+2 chemotherapy), which means cytarabine on Days1-5 and either daunorubicin or idarubicin on Days 1-2. Regardless of your bone marrow findings onDay 14, you will receive Pembrolizumab (MK-3475) IV on Day 8. If you have a complete remission after thefirst part of therapy, you will continue with the second part of therapy thatconsists of up to four cycles of high dose cytarabine with Pembrolizumab(MK-3475). If you remain in completeremission after the second part of therapy, you will be monitored withoutPembrolizumab (MK-3475) therapy on Day 1 of each 21-day cycle for up to 2years. If you proceed with a transplant,you will forgo any remaining protocol-defined therapy.

    Participants between the ages of 18 and 75 who have newly diagnosed AML willbe enrolled into this study.

    Dinner, Shira NaomiDinner, Shira Naomi
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04214249 STU00213544
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    (xIRB) NCI CIRB ETCTN 10334: BLockade of PD-1 Added to Standard Therapy to Target Measurable Residual Disease in Acute Myeloid Leukemia 2 (BLAST MRD AML-2): A Randomized Phase 2 Study of the Venetoclax, Azacitadine, and Pembrolizumab (VAP) Versus Venetoclax and Azacitadine as First Line Therapy in Older Patients with Acute Myeloid Leukemia (AML) Who Are Ineligible or Who Refuse Intensive Chemotherapy

    The purpose of this study is to compare the usual treatment alone to adding MK-3475 (pembrolizumab) to the usual treatment. This study will help the study doctors find out if this different approach is better than the usual approach. To decide if it is better, the study doctors will …

    The purpose of this study is to compare the usual treatment alone to adding MK-3475 (pembrolizumab)

    to the usual treatment. This study will help the study doctors find out if this different approach is better than the usual approach. To decide if it is better, the study doctors will be looking to see if the addition of pembrolizumab results in fewer detectable leukemia using new methods.

    MK-3475 (pembrolizumab), is already approved by the FDA for use in several cancers.

    However, MK-3475 (pembrolizumab) is not approved by the FDA or known to be safe for use in AML either alone or in combination with standard chemotherapy.

    This study has 2 study groups. You will be told which group you are in.

    Group 1

    Participants in this group will get the usual study drugs, azacitidine on Days 1-7 and

    venetoclax on Days 1-28 of the first cycle and on Days 1-21 or Days 1-28 of each cycle thereafter

    depending on the results of your blood count. If you are unable to receive azacitidine over

    the weekend, your doctor may give it to you for 5 days in week 1 and 2 days in week 2.

    If you derive a clinical benefit within the first 6 cycles of therapy, you will continue

    with the second part of therapy that consists of the same combination for up to 3 years

    provided you do not stop responding at any time during the second part of therapy.

    Group 2

    Participants in this group will get the usual study drugs, azacitidine on Days 1-7 and

    venetoclax on Days 1-28 of the first cycle and on Days 1-21 or Days 1-28 of each cycle thereafter

    depending on the results of your blood count. If you are unable to receive azacitidine over

    the weekend, your doctor may give it to you for 5 days in week 1 and 2 days in week 2.

    You will receive MK-3475 (pembrolizumab) on Day 8 of the first cycle and every 3 weeks thereafter.

    If you derive a clinical benefit within the first 6 cycles of therapy,

    you will continue with the second part of therapy that consists of the same combination

    for up to 3 years provided you do not stop responding.

    Participants ages 60 years or older who have newly diagnosed AML will be enrolled in this study. 
    Dinner, Shira NaomiDinner, Shira Naomi
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04284787 STU00213545
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    (xIRB) NCI CIRB SWOG 1823: A Prospective Observational Cohort Study to Assess mRNA 371 for Outcome Prediction in Patients with Newly Diagnosed Germ Cell Tumors

    The purpose of this study is for the study doctors to learn if miRNA 371 is useful for predicting relapse in patients with germ cell cancer. A germ cell tumor is a type of cancer that occurs in the ovaries (for females) or the testes (for males). This tumor may …

    The purpose of this study is for the study doctors to learn if miRNA 371 is useful for predicting relapse

    in patients with germ cell cancer. A germ cell tumor is a type of cancer that occurs in the ovaries (for females) or the testes (for males). This tumor may also be found in the pelvis along the tailbone, the chest, the abdomen and in other structures of the body, generally along the midline of the body.

    A sample of your blood will be collected during regular clinic visits to look for the presence of a tumor marker called miRNA 371. The study doctors do not know if the test is as good as the usual care (tumor scans and bloodwork) in predicting when cancer will return (relapse) in patients with germ cell cancer. If better, this blood test could change the way patients are monitored for relapse in the future.

    If you decide to take part in this study, an extra tube of blood will be collected during your regular clinic visits for miRNA 371

    analysis for up to 3 years from enrollment into the study.

    Participants 18 years of age or older who have germ cell cancer will be enrolled.

    Kundu, Shilajit DKundu, Shilajit D
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00213585
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    DRUG AT148002: A Phase 1/2 Study of ALX148 in Combination with Azacitidine in Patients with Higher Risk Myelodysplastic Syndrome (MDS) (ASPEN-02)

    The purpose of this research study is to learn about the effects of the study drug, ALX148, in combination with azacitidine (AZA), a standard treatment for MDS. The study is being done to assess the safety and tolerability of ALX148, to document the levels of ALX148 in the blood, and …
    The purpose of this research study is to learn about the effects of the study drug, ALX148, in combination with azacitidine (AZA), a standard treatment for MDS. The study is being done to assess the safety and tolerability of ALX148, to document the levels of ALX148 in the blood, and to document the effects of ALX148 on your cancer when given together with AZA.

    This Phase 1/2 study includes two parts. In the Phase 1 part of this study, increasing doses of ALX148 will be given together with AZA. In the Phase 2 part of the study, ALX148 will be given at a dose selected from the Phase 1 part in combination with AZA. Depending on the timing, you will participate in either the Phase 1 or Phase 2.

    You will continue to receive treatment in the study as long as: you benefit from study treatment; you do not experience severe side effects; and you are willing to continue to undergo study-specific assessments. There is a 14-day screening period that will begin when you sign the consent form (up to 14 days before your first dose of ALX148), and a follow-up period for up to 3 years after your last dose of ALX148.

    This study will consist of a screening visit(s) and multiple cycles of study treatment and evaluation that will involve multiple visits to the clinic, an end of study visit, and a follow-up visit(s). ALX148 is administered by an intravenous (through a vein) infusion lasting approximately 60-90 minutes in the clinic. AZA will be given once daily either by vein or by injection under the skin for 7 days, every 4 weeks.

    The ALX148 study drug will be administered either every 2 or 4 weeks. AZA will be administered once daily for 7 days, every 4 weeks. A treatment cycle is 28 days both for ALX148 dosing every 2 or 4 weeks. It is possible that your treatment schedule may be changed. For example, your study doctor may start you on an every 4 week schedule and then change the schedule to every 2 weeks based on how well you tolerate the drug.

    Note: This is only a partial description of treatment. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

    Some of the eligibility criteria include:

    •Age of at least 18 years

    •Diagnosis of higher risk myelodysplastic syndrome (MDS) that is either no longer responsive to standard therapies of proven effectiveness and/or for which new safe and effective therapies need to be developed to improve outcomes.

    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

    Altman, Jessica KAltman, Jessica K
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04417517 STU00213414
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    DRUG ELVCAP-001-01: A Phase 2 Study of Seribantumab in Adult Patients with Neuregulin-1 (NRG1) Fusion Positive Locally Advanced or Metastatic Solid Tumors

    The purpose of this study is to test an experimental drug called seribantumab. This means that seribantumab is still being studied to better understand the potential efficacy and safety of the drug. It also means that the U.S. Food and Drug Administration (FDA) or regulatory authorities from other countries …

    The purpose of this study is to test an experimental drug called seribantumab. This means that seribantumab is still being studied to better understand the potential efficacy and safety of the drug. It also means that the U.S. Food and Drug Administration (FDA) or regulatory authorities from other countries do not allow it to be sold for treating patients. Seribantumab can only be used in research and on a clinical research trial. This study is being done:

    •To determine how well your NRG1 gene fusion positive cancer responds to treatment with seribantumab;

    •To determine how long any benefits from treatment with seribantumab last;

    •To determine the highest and safe dose of seribantumab for NRG1 fusion patients

    •To evaluate how the body absorbs and processes different doses of seribantumab (this is called pharmacokinetic (PK) testing);

    •To see if certain biomarkers from tumor tissue or blood samples are linked with positive or negative response outcomes

    This is an open-label study. This means that you, the study doctor, study staff, and the Sponsor will know the study drug and the doses that you are given.

    The length of the study will vary for each person and will be determined by the number of treatment cycles. Overall, you should expect to be on treatment for at least six months or longer. The number of study-visits you will have will be based on the following schedule:

    •Screening period: One or more visits for up to 28 days

    •Induction Treatment period: Weekly visits for 4 weeks.

    •Consolidation Treatment period: Every other week visits for 12 weeks and a total of 6 visits.

    •Maintenance Treatment period: Visits every three weeks until you end your treatment.

    If you are eligible, after the screening period, you will receive treatment with study drug once every 7-days for a total of four weeks. When you start treatment, you will be given an initial amount of seribantumab during your first visit. For your second, third and fourth visits during treatment, the dose of seribantumab will be adjusted based upon how well you and other patients tolerate the planned induction dose. Your study doctor and study team will let you know what dose you will receive for the second, third and fourth induction treatment visits.

    You will receive an infusion of the study drug directly into your vein. This is done by inserting a small hollow tube into a vein in your arm. The tube is placed into the vein with a needle. When the tube is in place, the needle is withdrawn, and the tube is secured with tape. The infusion will take about 60 minutes. Following the study drug infusion, your study doctor may require you to stay in the study clinic for up to an hour or longer, so that he/she can monitor you.

    Note: This is only a partial description of treatment. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

    Some of the eligibility criteria include:

    •Age of at least 18 years

    •Diagnosis of advanced or metastatic tumor that is believed to be caused by a change in the NRG1 gene called a fusion

    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

    Chae, Young KwangChae, Young Kwang
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04383210 STU00213426
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    Serial Monitoring of Circulating Tumor Cells During Radiotherapy for Women with Non-Metastatic Breast Cancer: A Prospective Observational Cohort Study

    The purpose of this research is to determine whether radiotherapy after surgery to remove a breast cancer can help decrease the number of circulating tumor cells (CTCs) in the blood. Circulating tumor cells are cancer cells that are shed from the tumor into the blood stream and are believed to …

    The purpose of this research is to determine whether radiotherapy after surgery to remove a breast cancer can help decrease the number of circulating tumor cells (CTCs) in the blood. Circulating tumor cells are cancer cells that are shed from the tumor into the blood stream and are believed to be one of the first indicators that breast cancer cells may remain after surgery. Approximately 20% of women with early-stage breast cancer can be found to have CTCs in a small sample of blood taken several weeks after surgery. Radiotherapy is used after surgery to remove a breast cancer in order to sterilize any cancer cells that may be remaining in the breast. It is not known if radiotherapy can help decrease or eliminate CTCs that are found in the blood. This study aims to find out if testing for CTCs can be clinically useful for guiding radiotherapy treatment decisions. Another aim of this study is to evaluate whether CTCs can be used to measure the effectiveness of radiotherapy in an individual patient.

    Eligible participants are post-menopausal women that have been diagnosed with non-metastatic, ER-positive and Her2-nonamplifed breast cancer and are planning on receiving radiation and hormone therapy.

    Strauss, Jonathan BStrauss, Jonathan B
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00212971
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    ECOG-ACRIN 9181: A Phase III Randomized Trial of Steroids + Tyrosine Kinase Inhibitor Induction with Chemotherapy or Blinatumomab for Newly Diagnosed BCR-ABL-Positive Acute Lymphoblastic Leukemia in Adults

    This study is being done to answer the following question: This study is being done to determine what effects (good or bad) using the combination of potent TKI, steroids and blinatumomab versus treatment with steroids, TKI and chemotherapy. This investigational therapy will be added to what has traditionally been used …
    This study is being done to answer the following question: This study is being done to determine what effects (good or bad) using the combination of potent TKI, steroids and blinatumomab versus treatment with steroids, TKI and chemotherapy. This investigational therapy will be added to what has traditionally been used to treat your specific sub-type of ALL. Studies are being done in ALL and other blood cancers with blinatumomab. We are doing this study because we want to find out if this approach is better or worse than the usual approach for you. The usual approach is defined as care most people get for ALL.
    • Participants must be 18 years or older
    • Participants must have a confirmed diagnosis of newly diagnosed BCR-ABL-positive Acute Lymphoblastic Leukemia (ALL).
    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.
    Dinner, Shira NaomiDinner, Shira Naomi
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04530565 STU00213941
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    (xIRB) NCI CIRB ECOG-ACRIN 8191: Phase III Study of PET-Directed Local or Systemic Therapy Intensification in Prostate Cancer Patients with Post-Prostatectomy Biochemical Recurrence

    The purpose of this study is to compare the usual treatment alone to using PET/CT imaging to look for cancer that has spread to the pelvis plus the usual treatment. We want to see if we can provide a more targeted treatment to this type of cancer by treating …

    The purpose of this study is to compare the usual treatment alone

    to using PET/CT imaging to look for cancer that has spread to the pelvis plus the usual treatment.

    We want to see if we can provide a more targeted treatment to this type of cancer by treating up to 5

    specific lesions that are seen on the PET/CT scan. Part of the purpose of this study is also to see

    whether adding apalutamide and directed radiation works better than the usual approach to help treat

    prostate cancer that has returned after surgery.

    This study will help the study doctors find out if this different approach is better than the usual

    approach. To decide if it is better, the study doctors will be looking to see if the study approach

    increases the time before cancer growth or if the cancer causes major additional symptoms.

    This study has 4 study groups. Participants will be assigned to 1 of 4 possible treatment groups

    depending on the results of your PET/CT scan. After you finish your study treatment, your doctor will

    continue to follow your condition for up to 10 years and watch you for side effects and monitor the

    progression of your cancer.

    Group 1 (Negative for Extra Pelvic-Metastases)

    If you are in this group, it means your PET/CT scan did not show evidence that your cancer has spread

    to outside of the pelvis. You will get the usual appropriate care that is used to treat this type of

    cancer, the planned standard of care treatment with radiation therapy (SOC RT) and STAD for 6 months.

    Group 2 (Negative for Extra Pelvic-Metastases)

    If you are in this group, it means your PET/CT scan did not show evidence that your cancer has spread

    to areas outside of the pelvis. You will get a study treatment, planned SOC RT + STAD + apalutamide

    for 6 months.

    Group 3 (Positive for Extra Pelvic-Metastases)

    If you are in this group, it means that your cancer has spread to areas outside of your pelvis.

    You will get planned SOC RT + STAD + apalutamide for 6 months.

    Group 4 (Positive for Extra Pelvic-Metastases)

    If you are in this group, your cancer has spread to areas outside of your pelvis.

    You will get a planned SOC RT + STAD + apalutamide for 6 months + directed radiation therapy to

    where the cancer has spread. Each patient will undergo another (or additional) PET/CT scan,

    which will take place about one year after starting treatment or if clinically necessary at an

    earlier time point.

    Male participants 18 years of age or older who have prostate cancer that has come back after surgery

    will be enrolled into this study.

    Sachdev, SeanSachdev, Sean
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04423211 STU00214021
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    NU 20H07: Social Correlates of Variation in Intestinal and Oral Microbiome Among Hematopoietic Stem Cell Transplant Patients: A Geographic Exploration in the City of Chicago

    This study is being done to learn how the microbiome evolves through stem cell transplantation, how it can be shaped by socioeconomic status, the neighborhoods that people reside in, and their diet, as well as certain clinical factors (such as antibiotic usage). Study participants will be asked to provide a …

    This study is being done to learn how the microbiome evolves through stem cell transplantation, how it can be shaped by socioeconomic status, the neighborhoods that people reside in, and their diet, as well as certain clinical factors (such as antibiotic usage). Study participants will be asked to provide a saliva sample and complete a questionnaire.

    You may be eligible for this study if you have been diagnosed with a hematologic malignancy (also known as a blood cancer) and are being considered for an allogeneic hematopoietic stem cell transplantation (sometimes also referred to as a bone marrow transplant).

    Moreira, JonathanMoreira, Jonathan
    STU00213358
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    DRUG Q702-ONC-P1-US001 A Phase 1 Multicenter, Open-label, Dose-Escalation, Safety, Pharmacodynamic, Pharmacokinetic Study of Q702 with a Cohort Expansion at the RP2D in Patients with Advanced Solid Tumors

    The major purpose of this study is to determine the highest dose of Q702 that does not result in severe side effects, the dose that is tolerated, and once this dose is found, if it has any effect against the cancer in patients with solid cancer tumors. This study is …
    The major purpose of this study is to determine the highest dose of Q702 that does not result in severe side effects, the dose that is tolerated, and once this dose is found, if it has any effect against the cancer in patients with solid cancer tumors. This study is being done:

    • To test the safety of Q702 and see what effects (good and bad) it has on you and your cancer.
    • To find the highest dose of Q702 that can be given without causing serious side effects when treatment is given every day for 7 days, followed by 7 days of no treatment, repeated two times during a 28-day cycle.
    • To find the dose of Q702 that should be used in future studies.
    • To evaluate what the human body does and how the body reacts to Q702.

    This research is being performed because improvements are needed in the treatment of patients with cancer.

    We are asking you to take part in this research study because you have cancer that has continued to grow despite the treatments you have already received. Either the standard drugs and therapies used to treat your disease are no longer working or there are no known treatments which work because your tumor cells may be resistant to available treatments or you are not a candidate for or intolerant of available treatment. Your cancer had been confirmed by a pathologist (a person who studies the causes and effects of diseases).

    This clinical trial tests a study drug, Q702. The study drug, Q702, targets certain molecules present in cancer cells that may help activate your body's immune system to fight the cancer. The study drug, Q702, is not approved for sale by the FDA.

    Mahalingam, DevalingamMahalingam, Devalingam
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04648254 STU00213510
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    (xIRB) NCI CIRB NRG BN009: Phase III Trial of Salvage Stereotactic Radiosurgery (SRS) or SRS + Hippocampal-Avoidant Whole Brain Radiotherapy (HA-WBRT) for First or Second Distant Brain Relapse After Upfront SRS With Brain Metastasis Velocity >/= 4 Brain Metastases/Year

    The purpose of this study is to compare the usual treatment of SRS alone to SRS plus HA-WBRT (whole brain radiation therapy with hippocampus avoidance) and memantine for patients with cancer that has spread to the brain and come back in other areas of the brain after earlier treatment …

    The purpose of this study is to compare the usual treatment of SRS alone to SRS plus HA-WBRT

    (whole brain radiation therapy with hippocampus avoidance) and memantine for patients with cancer

    that has spread to the brain and come back in other areas of the brain after earlier treatment with SRS.

    The addition of HA-WBRT and memantine to the usual treatment could better control your brain cancer.

    This study will help the study doctors find out if this different approach is better, the same,

    or worse than the usual approach.

    Memantine is FDA approved for treating dementia and is commonly used off-label

    (that is, for a purpose for which it is not FDA approved) for patients receiving whole-brain

    radiation therapy for cancer that has spread to the brain.

    This study has 2 study groups. You will be told which group you are in.

    Group 1

    If you are in this group, you will get the usual treatment, SRS. In addition to the usual

    SRS treatment, you will also receive HA-WBRT. You will also be given the drug memantine,

    which has also been shown to preserve memory function. Memantine will be taken for up to 6 months.

    Group 2

    If you are in this group, you will get the usual treatment of SRS.

    After you finish your treatment, your doctor and study team will watch you for side effects and

    follow your condition. They will check you every 2 to 3 months for at least 1 year after you finish

    SRS. If you are receiving memantine, your doctor will continue to see you in the clinic as needed.

    Participants age 18 years or older who have receivedstereotactic radiosurgery to treat cancer that spread to the brain, and now thecancer has returned in other areas of the brain will be enrolled into thisstudy.

    Lukas, Rimas VincasLukas, Rimas Vincas
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04588246 STU00214371
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    (xIRB) NCI CIRB ECOG-ACRIN 2197: Optimal Perioperative Therapy for Incidental Gallbladder Cancer (OPT-IN): A Randomized Phase II/III Trial

    The purpose of this study is to compare the usual treatment(surgery plus chemotherapy after) to using chemotherapy both before and aftersurgery. This study will help the study doctors find out if thisdifferent approach is better than the usual approach. To decide if it isbetter, the study doctors will look …

    The purpose of this study is to compare the usual treatment(surgery plus chemotherapy after) to using chemotherapy both before and aftersurgery.

    This study will help the study doctors find out if thisdifferent approach is better than the usual approach. To decide if it isbetter, the study doctors will look to see if the chemotherapy increases thetime to disease recurrence and if it increases a patient’s overall survivalcompared to the usual approach given both before and after surgery.

    There are two groups in this study.

    Group 1 (Control Arm-Arm A) receives surgery and then 6 monthsof chemotherapy (gemcitabine/ cisplatin) after surgery.

    Group 2 (Treatment Arm-Arm B). In Group 2, participants willreceive 3 months of chemotherapy) prior to undergoing surgery, followed by 3months of chemotherapy after undergoing surgery.

    Participants will be randomly assigned to one group or theother. In Group 2, there will be a waiting period of approximately 4-8 weeksafter completion of chemotherapy before undergoing surgery. Only patients whohave not progressed with disease outside the area of the surgery will proceedto surgery.

    After all the treatment is done, participants will havefollow-up procedures with imaging studies (CT and/or MRI) every 3 months for 2years and every 6 months for year 3 after treatment or until diseaserecurrence, whichever comes first.

    Participants ages 18 years or older who have recently been diagnosedwith gallbladder cancer that was found after their gallbladder was removedduring surgery.
    Chawla, AkhilChawla, Akhil
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00214491
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    (xIRB) NCI CIRB Alliance A091902: A Multicenter Phase II Trial of Paclitaxel with and Without Nivolumab in Taxane Naïve, and Nivolumab and Cabozantinib in Taxane Pretreated Subjects with Angiosarcoma

    The purpose of thisstudy is to compare treatment with chemotherapy (paclitaxel) alone to using acombination of nivolumab plus chemotherapy (paclitaxel) treatment inparticipants with angiosarcoma who have not been treated with paclitaxel chemotherapyalone. Another purpose is to evaluate the effect of nivolumab in combinationwith cabozantinib on angiosarcoma (cancer) in participants who …

    The purpose of thisstudy is to compare treatment with chemotherapy (paclitaxel) alone to using acombination of nivolumab plus chemotherapy (paclitaxel) treatment inparticipants with angiosarcoma who have not been treated with paclitaxel chemotherapyalone. Another purpose is to evaluate the effect of nivolumab in combinationwith cabozantinib on angiosarcoma (cancer) in participants who have eitherreceived paclitaxel or similar chemotherapy previously, or whose cancer hasgrown previously while getting paclitaxel chemotherapy on this study.

    This study has 2 study groups.

    Participants enrolledinto group 1 are those who have not received prior chemotherapy treatment withpaclitaxel or similar “taxane” chemotherapy. In this group, participants willbe assigned to one of two arms. In Arm 1, participants will receive combinationof paclitaxel and nivolumab. Participants assigned to Arm 2, will only receivepaclitaxel.

    You will be put into astudy arm by chance. You will have a 50:50 chance of being in Arm 1 or Arm 2.If you are assigned to Arm 2 and your cancer gets worse you will have thechoice to receive cabozantinib and nivolumab if your doctor feels it wouldbenefit you.

    Participantsenrolled into group 2 are those that have received prior chemotherapy treatmentwith paclitaxel or a similar “taxane” chemotherapy or participants who progresswhile in Group 1. In this group, participants will receive a combination ofcabozantinib and nivolumab.

    After treatment is finished, participants will be followed every3 months for 3 years to be watched for side effects.

    Participants ages 18 years or older who have a type of cancer called angiosarcoma.
    Pollack, Seth MichaelsPollack, Seth Michaels
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04339738 STU00214492
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    (xIRB) NCI CIRB ECOG-ACRIN 8185: Phase 2 Study of Bladder-SparIng ChemoradiatioN with MEDI4736 (Durvalumab) in Clinical Stage 3, Node PosItive BladdeR CancEr (INSPIRE)

    The purpose of this study is to compare the usual treatment of chemotherapy and radiation to adding MEDI4736 (durvalumab) immunotherapy to the usual treatment. This study will help determine if this different approach is better than the usual approach. To decide if it is better, the study doctors will be …

    The purpose of this study is to compare the usual treatment of chemotherapy and radiation to adding MEDI4736 (durvalumab) immunotherapy to the usual treatment. This study will help determine if this different approach is better than the usual approach. To decide if it is better, the study doctors will be looking to see if the study approach increases the life of patients compared to the usual approach.

    This immunotherapy drug,MEDI4736 (durvalumab), is already approved by the FDA for use in metastatic bladder cancer.

    Participants who decide to take part in this study will either get chemotherapy and radiation for 6-8weeks, or will get MEDI4736 (durvalumab) immunotherapy in addition to chemotherapy and radiation for 6.5-8 weeks. Participants in the MEDI4736(durvalumab) Group 1 whose bladder cancer has responded (shrunk, gone away or remained stable) to treatment with chemotherapy, radiation and MEDI4736(durvalumab) will be offered more treatments with MEDI4736 (durvalumab) alone for up to 9 months.

    Participants who are in the arm with chemotherapy and radiation, and whose cancer has responded, will be watched closely without any additional chemotherapy and radiation treatments. Participants whose cancer has not responded, may be offered surgery or some other treatment.

    After study treatment is finished, participants will be followed by the study doctor for up to 3 years.

    Participants ages 18 years or older who have bladder cancer that has spread from the bladder to the lymph nodes will be enrolled into this study.

    VanderWeele, David JamesVanderWeele, David James
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04216290 STU00214716
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    (xIRB) NCI CIRB ETCTN 10285: Phase 1/2 Study of an EZH2 Inhibitor (Tazemetostat) in Combination with Dual BRAF/MEK Inhibition in Patients with BRAF- Mutated Metastatic Melanoma Who Progressed on Prior BRAF/MEK Inhibitor Therapy

    Participants 18 years or older who have metastatic melanoma, and the cancer has a change in the gene called the BRAF, and is not responsive to treatment with MEK and BRAF inhibitors will be enrolled. This study has two phases. Phase 1 and Phase 2. The purpose of Phase 1 …

    Participants 18 years or older who have metastatic melanoma, and the cancer has a change in the gene called the BRAF, and is not responsive to treatment with MEK and BRAF inhibitors will be enrolled.

    This study has two phases. Phase 1 and Phase 2.

    The purpose of Phase 1 is to test the safety of the study drug, tazemetostat, in combination with the usual treatment, dabrafenib and trametinib. This study tests different doses of tazemetostat with the usual dose of dabrafenib and trametinib to see which dose of tazemetostat is safest for people. Tazmetostatis not approved by the FDA for treatment of this type of cancer.

    All people taking part in this study will get the same dose of the usual intervention, dabrafenib and trametinib. However, people in this study will get different doses of the study drug, tazemetostat. Once the highest safe dose is found, phase 1 of the study is stopped.

    The purpose of Phase II is to compare the combination of tazemetostat, dabrafenib, and trametinib to tazemetostat alone. This study will help the study doctors find out if this different approach is better, the same, or worse than the usual approach. Another purpose of this study is for the study doctors to learn if a genetic test is helpful to decide if tazemetostat is more effective in patients whose cancer has an abnormal EZH2 gene. The combination of tazemetostat, trametinib, and dabrafenib, has not been administered together in patients and the combination of these agents are not FDA approved for the treatment of this type of cancer.

    Participants who take part in this study will either get a combination of usual approach of dabrafenib and trametinib, and the study drug, tazemetostat or will get the study drug, tazemetostat alone, until their disease gets worse or the side effects become too severe.

    Patient must be ≥18 years.

    Patient must have a diagnosis of BRAFV600E/K-mutated metastatic melanoma.

    Sosman, Jeffrey AlanSosman, Jeffrey Alan
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04557956 STU00214795
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    (xIRB) NCI CIRB SWOG 1925: Randomized, Phase III Study of Early Intervention with Venetoclax and Obinutuzumab Versus Delayed Therapy with Venetoclax and Obinutuzumab in Newly Diagnosed Asymptomatic High-Risk Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL): EVOLVE CLL/SLL Study

    The purpose of this study is to compare the early treatment(before you have symptoms) of venetoclax and obinutuzumab (V-O) to the usual treatment of V-O after you have symptoms. This study will help the study doctors find out if this different approach is better, the same, or …

    The purpose of this study is to compare the early treatment(before you have symptoms) of venetoclax and obinutuzumab (V-O) to the usual treatment of V-O after you have symptoms. This study will help the study doctors find out if this different approach is better, the same, or worse than the usual approach. Another purpose of this study is to find out how early V-O treatment affects patients’ physical, social, and emotional well-being, compared to patients receiving the standard delayed V-O treatment.

    The antibody, obinutuzumab, and the drug, venetoclax are already approved by the FDA for use in patients with previously untreated CLL or SLL. Most of the time these drugs are not used until a patient has symptoms that make treatment necessary.

    Participants who decide to take part in this study will either get treatment with venetoclax and obinutuzumab (V-O) that starts before symptoms start (now), or participants will get treatment with venetoclax and obinutuzumab (V-O) that will start after symptoms start (later). For all patients, the treatment with V-O will continue for 12 months or until the cancer gets worse, or the side effects are too great.

    After treatment is finished, participants will be followed for up to 10 years after enrollment.

    Participants ages 18 years or older who have chronic lymphocytic leukemia or small lymphocytic lymphoma and who do not have symptoms and do not need to start treatment now will be enrolled into this study.

    Ma, ShuoMa, Shuo
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04269902 STU00214799
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    (xIRB) NCI CIRB Alliance A011801: The COMPASSHER2 Trials (COMprehensive Use of Pathologic Response ASSessment to Optimize Therapy in HER2-Positive Breast Cancer): COMPASSHER2 Residual Disease (RD), A Double-Blinded, Phase III Randomized Trial of T-DM1 and Placebo Compared with T-DM1 and Tucatinib

    The purpose of this study is to compare the usual treatment with T-DM1 alone toT-DM1 plus tucatinib. This study will help the study doctors find out if this different approach is better than the usual approach. T-DM1 is already approved by the FDA for use in patients …

    The purpose of this study is to compare the usual treatment with T-DM1 alone toT-DM1 plus tucatinib. This study will help the study doctors find out if this different approach is better than the usual approach. T-DM1 is already approved by the FDA for use in patients with HER2-positive cancer. Tucatinib has not been FDA-approved to treat breast cancer.

    Participants who decide to participate will either get treatment with T-DM1 and placebo (a pill that looks like the study drug but contains no medication) or T-DM1 and tucatinib, for up to 14 cycles, unless the breast cancer returns or the side effects become too severe.

    After study treatment is finished, the study doctor will follow participants to watch for side effects and for signs of breast cancer returning. This may include a clinic visit every 6 months for 10 years.

    Participants age 18 years or older who have HER2-positive breast cancer, and who have already received treatment with chemotherapy and anti-HER2 targeted therapies followed by surgery. At the time of the surgery, cancer was still present in the breast and/or lymph nodes and was removed by a surgeon, will be enrolled into this study.

    Stein, Regina MStein, Regina M
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04457596 STU00214807
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    NU MSK20C04: PROTECT Study: A Phase II, Open-Label Trial of PROphylactic Skin Toxicity ThErapy with Clindamycin and Triamcinolone in Glioblastoma Patients Treated with Tumor Treating Fields

    Studyparticipants are being treated with Tumor Treating Fields (TTFields) formalignant glioma. The TTFields device uses low-intensity electrical fields totreat cancer, and this type of therapy can cause skin side effects, such asitching, sores, or infections. Researchers want to know if using clindamycingel and triamcinolone topical (on the skin) lotion …

    Studyparticipants are being treated with Tumor Treating Fields (TTFields) formalignant glioma. The TTFields device uses low-intensity electrical fields totreat cancer, and this type of therapy can cause skin side effects, such asitching, sores, or infections. Researchers want to know if using clindamycingel and triamcinolone topical (on the skin) lotion before these side effectsoccur may be able to prevent their appearance, so that TTFields can be usedwith less need for interruptions

    Key eligibility criteria include:

    • Diagnosis of newly diagnosed GBM or any malignant glioma with plan to initiate treatment with TTFields with or without systemic therapy, confirmed by the enrolling institution
    • Able to self-administer topical interventions or has available another person who can apply the topical agents
    • Treatment with TTF should be initiated within 7 days of planned initiation in this trial
    • Age of at least 18 years old

    All prospective patients will undergo screening tests to determine if they are eligible to take part in the study.

    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

    Kumthekar, Priya UKumthekar, Priya U
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04469075 STU00213944
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    (xIRB) NCI CIRB SWOG 2007: A Phase II Trial of Sacituzumab Govitecan (IMMU-132) (NSC #820016) for Patients with HER2-Negative Breast Cancer and Brain Metastases

    The purpose of this study is to examine the good and bad effects of taking the study drug sacituzumab govitecan. This study will help the study doctors to find out if taking the study drug, sacituzumab govitecan will help to decrease cancer in the brain more than usual treatment. The …

    The purpose of this study is to examine the good and bad effects of taking the study drug sacituzumab govitecan. This study will help the study doctors to find out if taking the study drug, sacituzumab govitecan will help to decrease cancer in the brain more than usual treatment. The study will also help the study doctors understand if taking the study drug extends the time until the cancer gets worse.

    Sacituzumab govitecan is not approved by the FDA for use in patients with HER2-negative breast cancer that has spread to the brain. It is approved for use in patients with metastatic triple negative breast cancer that was previously treated.

    Participants who are enrolled into this study will get the usual drugs selected by their study doctor that can help to prevent the side-effects that might be caused by the study drug. Participants will also get the study drug, sacituzumab govitecan, during each cycle. Each cycle lasts 21 days. This study has up to 35 cycles (or approximately 2 years).

    As long as the cancer does not get worse and participants do not experience severe side effects, and their study doctor determines that it is beneficial for them to remain on study, they will continue to get the study drug until completion of the study.

    Participants ages 18 years or older who have HER2-negative breast cancer with brain metastases that have spread after initial treatment will be enrolled into this study.
    Shah, Ami NShah, Ami N
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04647916 STU00214939
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    DRUG BB2121-MM-007: An Exploratory Phase 1/2 Trial to Determine Recommended Phase 2 Dose (RP2D), Safety and Preliminary Efficacy of bb2121 (Ide-cel) Combinations in Subjects with Relapsed/Refractory Multiple Myeloma (KarMMa-7)

    The purpose of this research study is to testthe safety and effectiveness of an investigational drug (bb2121) in combinationwith other treatments for patients diagnosed with multiple myeloma, a cancer ofthe plasma cells (a type of immune cell that produces antibodies), which hasreturned after a recent treatment regimen (relapsed), or has …

    The purpose of this research study is to testthe safety and effectiveness of an investigational drug (bb2121) in combinationwith other treatments for patients diagnosed with multiple myeloma, a cancer ofthe plasma cells (a type of immune cell that produces antibodies), which hasreturned after a recent treatment regimen (relapsed), or has not responded to arecent treatment regimen (refractory).

    Screening: the study doctor will perform tests foreligibility purposes. This may take up 28 days.

    Treatment: If eligible,participants will be assigned to one of the following Treatment Arms.

    Treatment Arm

    Treatment

    A

    bb2121 + CC-220 (± dexamethasone)

    B

    bb2121 + BMS-986405 (JSMD194)

    C Cohort 1

    bb2121 + Daratumumab, Pomalidomide and Dexamethasone

    C Cohort 2

    bb2121 + Pomalidomide, Bortezomib, and Dexamethasone

    The maximum time spent in the research study will depend on theparticipant’s response to treatment. Participants will be required to returnfor a visit at the time of study treatment discontinuation (End of TreatmentVisit) (except for Treatment Arm B). Participants may be followed up for up to15 years.

    In this research study, T cells will be collected from theparticipant’s blood in a procedure called leukapheresis. The collected cellswill then be modified in a laboratory. In the laboratory, a new gene will beinserted into your T cells using a genetically modified virus. Afterapproximately 4 to 6 weeks the modified T cells, now called bb2121 T cells,will be infused back into the participant’s blood.

    Note: This is only a partial description of treatment. Pleasecontact the Robert H. Lurie Comprehensive Cancer Center of NorthwesternUniversity if you are interested in the trial.

    · · Diagnosis of multiplemyeloma, a cancer of the plasma cells (a type of immune cell that producesantibodies), which has returned after your most recent treatment regimen(relapsed), or has not responded to your most recent treatment regimen(refractory).

    Note: This is only a partial list of eligibilitycriteria. Please contact the Robert H. Lurie Comprehensive Cancer Center ofNorthwestern University for complete screening information if you areinterested in this clinical trial.

    Singhal, SeemaSinghal, Seema
    NCT04855136 STU00214619
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    DRUG ALLO-605-201: A Single-Arm, Open-Label, Phase 1/2 Study Evaluating the Safety, Efficacy, and Cellular Kinetics/Pharmacodynamics of ALLO-647 and ALLO-605, an Anti-BCMA Allogeneic CAR T Cell Therapy in Patients with Relapsed/Refractory Multiple Myeloma

    The purpose of this research study is to test the safety of ALLO-605 and ALLO-647, and how effective ALLO-605 is in treating multiple myeloma, along with ALLO-647. Treatment with ALLO-647 and ALLO-605 is experimental and is not approved in the United States by the …

    The purpose of this research study is to test the safety of ALLO-605 and ALLO-647, and how effective ALLO-605 is in treating multiple myeloma, along with ALLO-647. Treatment with ALLO-647 and ALLO-605 is experimental and is not approved in the United States by the Food and Drug Administration (FDA) for use in the general public, although both treatments have been cleared for testing in clinical trials.

    Pre-screening: Participants will have a blood test to determine eligibility for the main study.

    Main study: Participants who qualify and agree to participate are expected to be in the study for approximately 36 months.

    The screening period will last up to 28 days. Once screening is complete and participants are determined to be eligible, they will enter the treatment phase of the study.

    While in the trial, participants will be asked to come to the clinic for approximately 27 study visits. At six of these visits participants will receive study treatment (i.e., lymphodepletion with fludarabine, cyclophosphamide, and ALLO-647, or treatment with ALLO-605). The remaining visits will involve procedures to monitor safety, and to evaluate any effect on the participant’s multiple myeloma.

    The study is made up of two parts. The first part is called dose escalation (Phase 1) and the second part is called dose expansion (Phase 2). In the dose escalation phase, the study will test different doses of ALLO-605, following lymphodepletion with a combination of medicines that includes different doses of ALLO-647, to determine safety and which is most effective. In the dose expansion phase of the study, one ALLO-605 dose level and a lymphodepleting regimen will be chosen for further evaluation, and additional patients treated with those doses.

    Some of the eligibility criteria include:

    •Age of at least 18 years

    •Diagnosis of multiple myeloma

    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

    Singhal, SeemaSinghal, Seema
    NCT05000450 STU00215605
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    NU 22H01: Serial Monitoring of Circulating Plasma Cells and Plasma Cell Components in Adults with Plasma Cell Disorders

    This study is being done to collect, process, and store blood samples of plasma cell disorder patients. The collected blood samples will be used for research projects to study the abnormal plasma cells and compare the results to current tests being done. This will provide an opportunity to better understand …

    This study is being done to collect, process, and store blood samples of plasma cell disorder patients. The collected blood samples will be used for research projects to study the abnormal plasma cells and compare the results to current tests being done. This will provide an opportunity to better understand how a patient is responding to treatment and to assess the stage of the patient’s disease.

    This study will use different tests that are not FDA approved. This test is being studied as a less invasive way to monitor amount of disease in a patient (versus invasive bone marrow biopsy). Current blood tests show the levels of the product of the cancer cell - not the levels of the cells themselves. Sometimes the cancer cells do not make this product and can therefore go undetected in standard tests. This study will show the number of cells. These tests will help identify, and analyze circulating plasma cells (CPCs), which are cells that have escaped into the bloodstream (a characteristic of plasma cell disorders). We will also look at any plasma cell components, such as genes in the DNA and RNA. Part of your samples will be used for Next Generation Sequencing (NGS) to evaluate any changes in your genes. NGS is a useful tool that determines the sequence of your DNA.

    You may be eligible for this research study if you have a plasma cell disorder.

    Singhal, SeemaSinghal, Seema
    STU00216869
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    (xIRB NCI CIRB) NRG GI008: Colon Adjuvant Chemotherapy Based on Evaluation of Residual Disease (CIRCULATE-US)

    This Phase II/III trial will evaluate what kind of chemotherapy to recommend to patients based on the presence or absences of circulating tumor DNA (ctDNA) after surgery for colon cancer. Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center …

    This Phase II/III trial will evaluate what kind of chemotherapy to recommend to patients based on the presence or absences of circulating tumor DNA (ctDNA) after surgery for colon cancer.

    Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

    Some of the eligibility criteria include:

    · Participants must have a diagnosis of histologically/pathologically confirmed Stage IIIA or Stage IIIB colon adenocarcinoma

    · Participants must be 18 or older

    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

    Mulcahy, Mary FrancesMulcahy, Mary Frances
    NCT05174169 STU00217884
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    A Multicenter, Adaptive, Randomized Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for the Treatment of COVID-19 in Hospitalized Adults

    ACTT-4 will evaluate the combination of baricitinib and remdesivir compared to dexamethasone and remdesivir in adult patients hospitalized with COVID-19 and requiring supplemental oxygen administered by low flow, high flow, or non-invasive mechanical ventilation.  …
    ACTT-4 will evaluate the combination of baricitinib and remdesivir compared to dexamethasone and remdesivir in adult patients hospitalized with COVID-19 and requiring supplemental oxygen administered by low flow, high flow, or non-invasive mechanical ventilation. 

    Hospitalized adults (>18 years) with symptoms suggestive of COVID-19

    Illness of any duration and laboratory-confirmed SARS-CoV-2 infection within 14 days

    Requires low or high flow oxygen devices or non-invasive mechanical ventilation

    Has not received 5 or more doses of remdesivir as treatment for COVID-19

    Has not receive 6mg or more of dexamethasone in one day, on more than one day in the past 7 days

    Taiwo, Babafemi OTaiwo, Babafemi O
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04280705 STU00212207
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    A Long-Term Non-Interventional Registry to Assess Safety and Effectiveness of HUMIRA® (Adalimumab) in Patients with Moderately to Severely Active Ulcerative Colitis (LEGACY)

    A Long-Term Non-Interventional Registry to Assess Safety and Effectiveness of HUMIRA® (Adalimumab) in Patients with Moderately to Severely Active Ulcerative Colitis (LEGACY)…
    A Long-Term Non-Interventional Registry to Assess Safety and Effectiveness of HUMIRA® (Adalimumab) in Patients with Moderately to Severely Active Ulcerative Colitis (LEGACY)
    Hanauer, Stephen BHanauer, Stephen B
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT01848561 STU00094204
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    Healthy Control Esophageal Registry and Biorepository

    This study is being done to compare how the esophagus and upper stomach work in people who have Scleroderma with symptoms of reflux disease or difficulty swallowing (dysphagia) to healthy controls. We will collect skin, esophageal and stomach biopsies (small pieces of tissue) to be used for several studies.…
    This study is being done to compare how the esophagus and upper stomach work in people who have Scleroderma with symptoms of reflux disease or difficulty swallowing (dysphagia) to healthy controls. We will collect skin, esophageal and stomach biopsies (small pieces of tissue) to be used for several studies.
    Must not be:
    - Obese (i.e. BMI ≥30)
    - Known medical illnesses that could affect esophageal function, gene expression or histology
    - Have a diagnosis of an eating disorder
    - Have a diagnosis of an autoimmune disease
    - A current or previous smoker (smoked >100 cigarettes in lifetime)
    - Have a history of alcohol abuse or addiction or score of 2 or higher on the CAGE questionnaire
    - Taking antacids and/or proton pump inhibitors for heartburn
    - Allergies to Fentanyl or Midolazam (sedatives used during endoscopy)
    - Allergies to Lidocaine (Lidocaine anesthetic jelly used during manometry).
    - Pregnant or nursing (hormones associated with pregnancy and lactation are known to affect esophageal function)
    Carlson, Dustin AllanCarlson, Dustin Allan
    • Map it 633 N. St. Clair St.
      Chicago, IL
    STU00096856
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    An Open-Label Extension and Safety Monitoring Study of Patients With Moderately to Severely Active Crohn’s Disease Previously Enrolled In The Etrolizumab Phase III Protocol GA29144 (Protocol GA29145)

    An Open-Label Extension and Safety Monitoring Study of Patients With Moderately to Severely Active Crohn’s Disease Previously Enrolled In The Etrolizumab Phase III Protocol GA29144 (Protocol GA29145)…
    An Open-Label Extension and Safety Monitoring Study of Patients With Moderately to Severely Active Crohn’s Disease Previously Enrolled In The Etrolizumab Phase III Protocol GA29144 (Protocol GA29145)
    Hanauer, Stephen BHanauer, Stephen B
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02403323 STU00201259
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    Semen quality in males with inflammatory bowel disease: Influence of medication for IBD

    Semen quality in males with inflammatory bowel disease: Influence of methotrexate, ustekinumab and tofacitinib treatment.
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00201469
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    Combined Phase 3, Double-blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Crohn’s Disease

    Combined Phase 3, Double-blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Crohn’s Disease…
    Combined Phase 3, Double-blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Crohn’s Disease
    Hanauer, Stephen BHanauer, Stephen B
    NCT02914561 STU00205056
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    A PHASE 3 SINGLE CENTER STUDY OF ISLET TRANSPLANTATION IN NON-UREMIC DIABETIC PATIENTS

    Type 1 diabetes is an autoimmune disease in which the insulin-producing pancreatic beta cells are destroyed, resulting in poor blood sugar control. The purpose of this study is to determine the safety and effectiveness of islet transplantation, combined with immunosuppressive medications, specifically using Campath as induction, for treating type 1 diabetes in individuals experiencing hypoglycemia unawareness and severe hypoglycemic episodes.
    Borja-Cacho, DanielBorja-Cacho, Daniel
    NCT01897688 STU00059469
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    Chronic Kidney Disease Research Biorepository

    The objective of this study is to create a biorepository of stored blood and urine specimens and demographic and clinical data collected from patients with chronic kidney disease and healthy volunteers for use in chronic kidney disease research
    Isakova, TamaraIsakova, Tamara
    • Map it 633 N. St. Clair St.
      Chicago , IL
    STU00201546
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    Transformative Research In Diabetic Nephropathy (TRIDENT) (SP0043185)

    This is a prospective, observational, cohort study of patients with a clinical diagnosis of diabetes who are undergoing clinically indicated kidney biopsy. The intent is to collect, process, and study kidney tissue and to harvest blood, urine and genetic materials to elucidate molecular pathways and link them to biomarkers that …
    This is a prospective, observational, cohort study of patients with a clinical diagnosis of diabetes who are undergoing clinically indicated kidney biopsy. The intent is to collect, process, and study kidney tissue and to harvest blood, urine and genetic materials to elucidate molecular pathways and link them to biomarkers that characterize those patients have a rapid decline in kidney function (> 5 mL/min/1.73m2/year) from those with lesser degrees of kidney function change over the period of observation. High through-put genomic analysis associated with genetic and biomarker testing will serve to identify key potential therapeutic targets for DKD by comparing patients with rapid and slow progression patterns. Each participating clinical site will search for, consent, harvest the biopsy sample, and enroll the participants as required for the TRIDENT protocol.
    Inclusion Criteria
    • Type 1 and 2 Diabetes by ADA criteria (see appendix )
    • Willingness to comply with study requirements, including intention to fully participate in protocol-specified follow-up at a clinical study site
    • Able to provide informed consent
    • Adult participants (no age restriction)
    • Planned medically indicated kidney biopsy, prescribed by a practicing nephrologist
    Exclusion Criteria
    • ESRD, defined as chronic dialysis or kidney transplant
    • History of receiving dialysis for more than 30 days
    • Institutionalized
    • Solid organ or bone marrow transplant recipient at time of first kidney biopsy
    • Less than 3-year life expectancy
    • Known alcohol or substance abuse
    • Unable to provide informed consent
    • No evidence of active cancer other than non-melanoma skin cancer
    Isakova, TamaraIsakova, Tamara
    • Map it 633 N. St. Clair St.
      Chicago , IL
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02986984 STU00204808
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    Evaluation of Renal Microvascular Perfusion by Contrast Enhanced Ultrasound

    Contrast Enhanced Ultrasound Study:The study’s purpose is to measure blood flow to and from the kidney via contrast-enhanced ultrasound (contrast agent, Lumason®, is given via IV administration)Participation consists of 5 study visits that are spread out over the course of 24 months (Healthy and ESRD participants …

    Contrast Enhanced Ultrasound Study:

    • The study’s purpose is to measure blood flow to and from the kidney via contrast-enhanced ultrasound (contrast agent, Lumason®, is given via IV administration)
    • Participation consists of 5 study visits that are spread out over the course of 24 months (Healthy and ESRD participants only complete the first 2 study visits)
    • Study procedures consist of measuring height, weight, and vital signs, answering questions about demographics and medical history, a blood draw and urine collection at every visit, and undergoing the contrast-enhanced ultrasound (only at visit 2)
    INCLUSION CRITERIA:
    • ≥ 18 years of age
    • Patient is able to provide written informed consent
    • Meet criteria for one of following patient populations:
    • CKD
    • eGFR ≥30 and <90 ml/min/1.73m2 by CKD Epidemiology Collaboration (CKD EPI) equation17 (with or without history of hypertension)
    AND
    • Urine albumin to creatinine ratio (UACR) ≥ 30mg/g creatinine
    OR
    • eGFR <30 ml/min/1.73m2 by CKD Epidemiology Collaboration (CKD EPI) equation (with or without history of hypertension AND with no UACR requirement)
    • ESRD
    • Currently receiving dialysis (hemodialysis or peritoneal dialysis)
    • No eGFR or UACR requirement
    • Healthy volunteer
    • No prior history of kidney disease (as defined by eGFR >60 ml/min/1.73m2 by CKD Epidemiology Collaboration (CKD EPI) equation and UACR <30 mg/g creatinine, based on Screening Visit lab results or average between local lab results (collected within 3 months from the date of the Screening Visit) and lab results from Screening Visit.
    • No self-reported history of hypertension, diabetes mellitus, liver disease, or cardiovascular disease

    • CKD-Biopsy
    • eGFR <90 ml/min/1.73m2 by CKD EPI equation
    OR
    • Urine albumin to creatinine ratio (UACR) ≥30 mg/g creatinine
    AND
    • Undergoing a clinically indicated renal biopsy
    • Transplant Kidney Biopsy
    • Kidney transplant recipient undergoing a protocol surveillance transplant kidney biopsy

    EXCLUSION CRITERIA:

    • Known hypersensitivity to sulfur hexafluoride lipid or to any component of Lumason®
    • Known severe pulmonary hypertension (pulmonary artery pressure > 75mmHg)
    • Active cardiac disease including any of the following:
    • Unstable angina
    • Myocardial infarction within 48 hours prior to date of proposed Lumason® administration
    • Severe arrhythmia (ventricular tachycardia, uncontrolled atrial fibrillation with rapid ventricular response, torsades de pointes)
    • Escalating vasopressor requirements in prior 24 hours
    • Recent neurological compromise (i.e. cerebrovascular accident including transient ischemic attacks within 3 months of Lumason® administration)
    • Emergency cardiac surgery
    • BMI ≥ 35 kg/m2
    • Clinical signs of acute rejection as the indication for transplant kidney biopsy
    • Inability for patient or patient’s surrogate to provide informed consent
    • Pregnancy
    • Incarcerated individuals

    Srivastava, AnandSrivastava, Anand
    • Map it 633 N. St. Clair St.
      Chicago , IL
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00206894
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    A Randomized, Multicenter, Double-Blind, Parallel, Active-Control Study of the Effects of Sparsentan, A Dual Endothelin Receptor and Angiotensin Receptor Blocker, on Renal Outcomes in Patients with Primary Focal Segmental Glomerulosclerosis

    (ACTIVE, NOT RECRUITING) This is a randomized, multicenter, double-blind, parallel, active-control study. The investigational drug (sparsentan) is a dual acting angiotensin receptor blocker and endothelin receptor agonist. The active control is irbesartan. Patients who meet eligibility criteria will require wash out from renin-angiotensin-aldosterone system (RAAS) blockers, if applicable prior to their first dose of study drug. Patients will be randomly assigned in a 1:1 ratio to receive either sparsentan or active control (irbesartan). 
    Inclusion Criteria:
    1. Primary FSGS
    2. Male or Female aged 18-75 years
    3. Urine protein/creatinine ratio ≥ 1.5 g/g
    4. Estimated glomerular filtration rate (eGFR) ≥ 30
    5. Blood pressure criteria: ≥100/60 mmHg and ≤160/100 mmHg
    6. Women of child bearing potential must agree to the simulataneous use of 2 medically accepted methods of contraception from randomization until 90 days after the last dose of study medication. Males, unless surgically sterile, must agree to use highly reliable methods of contraception from randomization until 90 days after the last dose of study medication.
    Exclusion Criteria:
    1. Secondary FSGS
    2. History of type 1 diabetes, uncontrolled type 2 diabetes, organ transplantation, heart failure (Class II-IV), malignancy, significant valvular disease, or alcohol/substance abuse.
    3. History of significant cerebrovascular disease and/or coronary artery disease within 6 months
    4. Body Mass Index (BMI) > 40
    3. Females who are pregnant, plan to become pregnant through the course of the study, or are breastfeeding. Males who plan to father a child during the course of the study.
    Ghossein, CybeleGhossein, Cybele
    NCT03493685 STU00206193
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    Immune checkpoint inhibitor-associated acute kidney injury

    Since 2011, six immune checkpoint inhibitors (ICIs), a type of immunotherapy, have been approved by the Federal Drug Administration for use in patients with cancer.  These medications have been demonstrated to have great promise for treating a variety of cancers.  However, there are toxicities associated with these agents, …
    Since 2011, six immune checkpoint inhibitors (ICIs), a type of immunotherapy, have been approved by the Federal Drug Administration for use in patients with cancer.  These medications have been demonstrated to have great promise for treating a variety of cancers.  However, there are toxicities associated with these agents, known as immune-related adverse events (AKI), some of which can be fatal.  Affected organs include the skin (rash), gastrointestinal tract(diarrhea), and the kidneys (acute kidney injury [AKI]). This study, led by Drs. Shruti Gupta and David Leaf at Brigham and Women’s Hospital, has the goal of collecting data on over 300 ICI-associated acute kidney injury cases from more than 30 academic medical centers worldwide.  We will characterize the clinical features of ICI-associated AKI in the hope that this will help us to determine predictors  of toxicity and best practices for management. 
    Aggarwal, VikramAggarwal, Vikram
    STU00212602
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    Chicago Lupus Database

    Establishing in 1991 and maintained by Northwestern University, the Chicago Lupus Database (CLD) is a registry of individuals with lupus who are willing to be contacted about future lupus research studies for which they might be eligible. Participants can enroll in any number of research studies designed to help us …
    Establishing in 1991 and maintained by Northwestern University, the Chicago Lupus Database (CLD) is a registry of individuals with lupus who are willing to be contacted about future lupus research studies for which they might be eligible. Participants can enroll in any number of research studies designed to help us learn more about lupus.
    Men and women 18 years or older with either a probable or definite lupus diagnosis can sign up for the Chicago Lupus Database.
    Ramsey-Goldman, RosalindRamsey-Goldman, Rosalind
    • Map it 633 N. St. Clair St.
      Chicago, IL
    STU00009193
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    Synovial Macrophage Transcriptional Signatures for Predicting Therapeutic Efficacy

    We know that in rheumatoid arthritis (RA), considerable thickening of the lining layer (synovium) in the joints occurs. This represents the accumulation of new cells and tissue. We would like to learn more about what contributes to the disease progression of RA and why some people respond to RA therapy, …
    We know that in rheumatoid arthritis (RA), considerable thickening of the lining layer (synovium) in the joints occurs. This represents the accumulation of new cells and tissue. We would like to learn more about what contributes to the disease progression of RA and why some people respond to RA therapy, while others do not. To do this, we will examine the cells, genetic material, proteins and other features in the tissue from the inflamed joints and blood of patients with RA. We hope that by studying this tissue and blood, we may learn information that may help lead to the development of new treatments for this disease.
    • Diagnosis of rheumatoid arthritis (RA).
    • Must have been 18 years of age or older at the time of diagnosis of RA.
    • At least one swollen joint (elbow, writs, knee, ankle, or shoulder) due to active RA.
    Perlman, Harris RPerlman, Harris R
    • Map it 633 N. St. Clair St.
      Chicago, IL
    STU00104822
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    LIFT: Lupus Intervention for Fatigue Trial

    This study is designed to evaluate the effectiveness of one-on-one counseling sessions on reducing symptoms of fatigue in persons with lupus by providing them with individualized coaching on increasing physical activity and improving diet.
    Have lupus and experience fatigue as a result.

    At least 18 years old.

    Can participate in physical activity.

    Live in the Chicago area.

    Be able to speak and read English.

    Be able to consent to being in the study.

    Ramsey-Goldman, RosalindRamsey-Goldman, Rosalind
    • Map it 633 N. St. Clair St.
      Chicago, IL
    NCT02653287 STU00201960
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    Vasculitis Clinical Research Consortium (VCRC) Genetic Repository One Time DNA Protocol

    The study is being done to identify genes that increase the risk of developing vasculitis. The purpose of the study is to: Collect clinical data and genetic information (DNA) on patients with vasculitis; Discover genetic markers that increase the risk of developing vasculitis; Discover genetic markers linked with certain symptoms …
    The study is being done to identify genes that increase the risk of developing vasculitis. The purpose of the study is to: Collect clinical data and genetic information (DNA) on patients with vasculitis; Discover genetic markers that increase the risk of developing vasculitis; Discover genetic markers linked with certain symptoms of vasculitis. The study involves donating one tube of blood for the collection of genetic information (DNA) at one study visit.
    - Giant Cell Arteritis- Takayasu’s Arteritis - Polyarteritis Nodosa - Granulomatosis with Polyangiitis (Wegener’s) - Microscopic Polyangiitis - Eosinophilic granulomatosis with polyangiitis (Churg-Strauss)
    Dua, Anisha BharadwajDua, Anisha Bharadwaj
    • Map it 633 N. St. Clair St.
      Chicago, IL
    STU00206908
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    The Collaborative, National Quality and Efficacy Registry (CONQUER)

    The CONQUER Registry will enable researchers to:Determine whether certain disease features are associated with or predict clinical and patient-reported outcomes (short-term and long-term).Identify which patients require early and aggressive intervention and which patients are better suited for “watchful waitingEvaluate the response in the real world (…

    The CONQUER Registry will enable researchers to:

  • Determine whether certain disease features are associated with or predict clinical and patient-reported outcomes (short-term and long-term).
    • Identify which patients require early and aggressive intervention and which patients are better suited for “watchful waiting
  • Evaluate the response in the real world (as opposed to the controlled and constrained setting of a clinical trial) to therapeutic agents and to combinations of therapeutic agents.
    • Drive more personalized and effective therapy for patients
    • Develop insights into drug toxicities that are unique to scleroderma patients (e.g. underlying heart disease due to pulmonary vascular disease)
    • Understanding patient satisfaction/issues with the current Standard of Care
  • Collect biosamples for future analyses (e.g. genetic factors contributing to disease)
  • Establish and support a collaborative network for U.S. scleroderma investigators
  • Support the critical infrastructure for future scleroderma studies, including trials for novel therapeutics
  • Patients must:

    1. Be 18 years of age and older

    2. Have a confirmed diagnosis of systemic sclerosis (meeting the 2013 SSc ACR/EULAR criteria)

    3. Have had symptoms of SSc for less than 5 years (other than Raynauds - it is okay if this has been going on for greater than 5 years)

    Richardson, CarrieRichardson, Carrie
    • Map it 633 N. St. Clair St.
      Chicago, IL
    • Map it 675 N. Saint Clair St. Fourteenth Floor, Suite 100
      Chicago, IL
    STU00207506
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    Large Vessel Vasculitis Tissue Registry and Repository (LVVRR)

    The purpose of this study is to investigate the roles that specific cells in the immune system and their signals play in large vessel vasculitis (giant cell arteritis, GCA). In large vessel vasculitis, blood vessels such as the temporal arteries that run along the sides of the head can become …
    The purpose of this study is to investigate the roles that specific cells in the immune system and their signals play in large vessel vasculitis (giant cell arteritis, GCA). In large vessel vasculitis, blood vessels such as the temporal arteries that run along the sides of the head can become inflamed, commonly causing headaches, joint pain, facial pain, fever, and difficulties with vision.

    We will study the gene expression (i.e., the genes that are being "read" to make proteins) in these immune cells, with a special focus on macrophages (one type of cell in the immune system). We will compare the gene expression in patients with vasculitis to the gene expression in people without vasculitis to determine what goes wrong in patients with this condition. If we can identify the molecular pathways that are affected in vasculitis, we can begin to develop treatments that will target these pathways. This may help us predict which patients will respond to treatment in the future.

    Patients who participate in this research will:

    • Complete a screening and demographic form
    • Complete questionnaires
    • Give 2 tubes of blood
    • Donate a portion of the left-over biopsy tissue taken during your standard of care temporal artery biopsy procedure

    Participants will be given a stipend after the samples (blood and biopsy) have been collected.

    For Vasculitis Patients:

    • Suspected large vessel vasculitis - meet two of the giant cell arteritis (GCA) criteria, one of which is onset at age 50 or older
    • Planning to undergo a temporal artery biopsy

    For Controls:

    • Undergoing intracranial surgery from temporal approach for reasons unrelated to inflammatory autoimmune disease

    Dua, Anisha BharadwajDua, Anisha Bharadwaj
    • Map it 675 N. Saint Clair St. Fourteenth Floor, Suite 100
      Chicago, IL
    • Map it 633 N. St. Clair St.
      Chicago, IL
    STU00210635
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    CNS Pain Mechanisms in Early Rheumatoid Arthritis: Implications for the Acute to Chronic Pain Transition

    Finding a way to reduce pain is consistently named as one of the top priorities for patients with RA. Previous research has found that this ongoing pain may in part be caused by problems in the way the brain processes pain signals. This is called pain centralization. This study will …

    Finding a way to reduce pain is consistently named as one of the top priorities for patients with RA. Previous research has found that this ongoing pain may in part be caused by problems in the way the brain processes pain signals. This is called pain centralization. This study will identify factors that lead to the development of pain centralization, so that in future studies we can learn more about how to prevent the development of this kind of chronic pain in RA.

    Participants will complete a total of 3 study visits (baseline, 3 months and 12 months). At each study visit, participants will have a physical exam, have blood drawn, answer questionnaires, and undergo quantitative sensory testing to assess responses to pressure and coldness. A subset of patients who are interested and eligible will undergo a brain MRI at baseline and the 12-month study visit. Participants will receive $50 for the completion of each study visit and an additional $100 for completing each MRI.

    Study participants must be 18 years or older with active Rheumatoid Arthritis and symptoms starting no more than one year prior to study participation.  Participants taking pain medications must be on a stable dose for at least 3 months.  Patients with Raynauds requiring treatment are not eligible to participate.  Participants must refrain from taking prednisone (greater than 10 mg) or opioids within 24 hours of their study visit.  
    Lee, Yvonne ClaireLee, Yvonne Claire
    • Map it 710 N. Fairbanks Ct. Olson Paivlion
      Chicago, IL
    • Map it 633 N. St. Clair St.
      Chicago, IL
    STU00211593
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    Sleep Fragmentation, Autonomic Dysfunction, and Centralized Pain in Rheumatoid Arthritis

    This study is looking at the relationship between sleep and pain in patients with RA. The goal of the study is to learn how toprevent the development of chronic pain in RA in the future. The study involves one study visit at thedowntown campus at Northwestern, completing questionnaires, undergoing quantitative …
    This study is looking at the relationship between sleep and pain in patients with RA. The goal of the study is to learn how toprevent the development of chronic pain in RA in the future. The study involves one study visit at thedowntown campus at Northwestern, completing questionnaires, undergoing quantitative sensory testing, wearing a wristmonitor (similar in size and appearance to a digital watch) to collectinformation about participant's sleep patterns, and wearing a patch to measureheart rate for about two weeks. Participantsare paid $50 for their time and effort.
    Participants must be 18 years or older and English-speaking with a confirmed diagnosis of Rheumatoid Arthritis. Participants cannot be taking beta blockers, certain pain medications, sedatives, or more than 10 mg of prednisone daily. Participants cannot have a history of heart conditions or work night shifts.
    Lee, Yvonne ClaireLee, Yvonne Claire
    • Map it 633 N. St. Clair St.
      Chicago, IL
    STU00211633
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    A Phase IIa, Double-Blind, Randomised, Intracohort Placebo-Controlled, Multicentre Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of EHP-101 in Patients with Diffuse Cutaneous Systemic Sclerosis

    This trial is testing an experimental drug called EHP-101, which has already been tested in a small group of healthy participants in a research study conducted in Australia. It is now being tested for the first time in patients with diffuse cutaneous systemic sclerosis (dcSSc). This study drug has …
    This trial is testing an experimental drug called EHP-101, which has already been tested in a small group of healthy participants in a research study conducted in Australia. It is now being tested for the first time in patients with diffuse cutaneous systemic sclerosis (dcSSc). This study drug has not been approved by Regulatory Authorities such as the Food and Drug Administration in the United States or anywhere in the world. The aim of this research is to determine the safety of the study drug when delivered by multiple oral (by mouth) doses to individuals with dcSSc for up to 84 days. the study will also look at how well tolerated the study drug is and what effects it has on the body and how effective the study drug is and how long it is effective.

    Participants will be in the study for about 5 months and complete the following:

    • Assigned to one of four groups:
  • Cohort 1 - 25 mg once per day of either active drug or placebo
  • Cohort 2 - 25 mg twice per day of either active drug or placebo
  • Cohort 3 - 50 mg once per day of either active drug or placebo
  • Cohort 4 - 50 mg twice per day of either active drug or placebo
    • Within each group, the participant will be randomly assigned to receive active study drug or placebo (which looks like the study drug but contains no actual medication). Participants will be twice as likely to receive the active study drug as the placebo.
    • Attend 10 study visits, which may include a physical exam, vitals, test of the heart, blood tests, urine pregnancy test, eye exam, skin biopsies, and questionnaires.
    Participants will receive a stipend after each completed study visit.

    • Between 18 and 74 years old
    • Meet criteria for diffuse cutaneous systemic sclerosis (dcSSc)
    • Disease duration of 6 years or less
    • Skin score of at least 15
    • If taking immunosuppressants (such as mycophenolate, methotrexate, etc.) must be on a stable dose for at least 3 months
    • If taking prednisone, must be on a stable dose for at least 1 month and taking 10 mg or less
    • Females with childbearing potential must use a highly effect method of birth control throughout study and for at least 28 days after the last dose of study treatment
    • Males with female partners of childbearing potential must use an acceptable contraception method throughout the study and for 90 days after the last dose of study treatment and refrain from donating sperm during this period
    • Additional exclusion criteria apply
    Richardson, CarrieRichardson, Carrie
    • Map it 675 N. Saint Clair St. Fourteenth Floor, Suite 100
      Chicago, IL
    • Map it 633 N. St. Clair St.
      Chicago, IL
    NCT04166552 STU00213693
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    KD025-215: A Phase 2, Open-label Multicenter Study to Evaluate the Efficacy and Safety of Belumosudil in Subjects with Diffuse Cutaneous Systemic Sclerosis (dcSSc)

    This trial is testing whether belumosudil (KD025), the study drug, is safe and effective for patients with diffuse cutaneous systemic sclerosis (dcSSc). The study drug is "investigational" because it is not approved by the United States Food and Drug Administration (FDA) to treat any disease. It may be an effective …
    This trial is testing whether belumosudil (KD025), the study drug, is safe and effective for patients with diffuse cutaneous systemic sclerosis (dcSSc). The study drug is "investigational" because it is not approved by the United States Food and Drug Administration (FDA) to treat any disease. It may be an effective therapy for conditions such as skin thickening or lung disease.

    Participants in this study will participate for up to 60 weeks:

    • Receive the study drug 200 mg twice daily by mouth for 52 weeks
    • Complete study visits every two weeks for the first month and then monthly thereafter
    • During study visits, will have physical exam, blood and urine tests, tests of the heart and lungs, and complete questionnaires
    • Complete skin biopsies (two on the forearm) at three study visits

    A stipend will be offered to participants for each completed study visit.

    • At least 18 years old
    • Diagnosis of diffuse cutaneous systemic sclerosis (dcSSc)
    • Disease duration of 6 years or less
    • Active disease per the treating physician
    • Skin score of at least 15 and up to 40
    • Additional exclusion criteria apply

    Richardson, CarrieRichardson, Carrie
    • Map it 675 N. Saint Clair St. Fourteenth Floor, Suite 100
      Chicago, IL
    • Map it 633 N. St. Clair St.
      Chicago, IL
    NCT04680975 STU00213748
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    NAV3-32: A Comparison of Tc 99m Tilmanocept Quantitative Imaging with Immunohistochemical (IHC) Analysis of CD206 Expression in Synovial Tissue from Subjects Clinically Diagnosed with Rheumatoid Arthritis (RA)

    This trial is being done to determine the ability of technetium Tc 99m tilmanocept (study drug) to find inflammatory cells in the joints of patients with rheumatoid arthritis (RA) via imaging. The imaging results will also be compared to the different types of cells present in the joints affected by …
    This trial is being done to determine the ability of technetium Tc 99m tilmanocept (study drug) to find inflammatory cells in the joints of patients with rheumatoid arthritis (RA) via imaging. The imaging results will also be compared to the different types of cells present in the joints affected by RA. The goal is to determine if imaging can be used to better characterize inflammation for rheumatoid arthritis patients, which may be helpful in diagnosing and treating patients.

    Patients who participate will attend 3 clinic visits and 2 phone calls over 45 days and will complete the following:

    • Receive an investigational drug one time through an IV in the arm
    • Have pictures taken of their hands and wrists to look at the inflammatory cells in the joints
    • Have a physical exam
    • Undergo an ultrasound of their hands and wrists
    • Have a synovial (joint) tissue biopsy of the hand or wrist
    • Give blood and urine samples
    • Answer questions about their RA and health

    A stipend will be offered to participants for each completed study visit.

    • Meet criteria for rheumatoid arthritis (RA) and have active disease.
    • At least 18 years of age or older at the time of RA diagnosis.
    • Hand or wrist joint with swelling.
    • Use adequate birth control measures for the duration of the study.
    • If receiving traditional DMARDs, must be on therapy for at least 90 days and at a stable dose for at least 30 days.
    • If receiving biologic DMARDs, must be on a stable dose for at least 60 days.
    • If receiving NSAIDS or steroids, must be on a stable dose for at least 28 days and not be receiving more than 10 mg prednisone per day.
    • Additional exclusion criteria apply.
    Ruderman, Eric MRuderman, Eric M
    • Map it 675 N. Saint Clair St. Fourteenth Floor, Suite 100
      Chicago, IL
    • Map it 633 N. St. Clair St.
      Chicago, IL
    NCT04078191 STU00213603
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