University of Texas Southwestern

Risk Indicators of Sarcoidosis Evolution-Unified Protocol (RISE-UP)

Status: Recruiting

Location: University of Maryland, University of Texas Southwestern

Conditions: University of Maryland, University of Texas Southwestern

City/State:

Baltimore, Maryland

Dallas, Texas

Contact Information:

Laura Koth
4155144369
[email protected]

Jessica Cardenas
[email protected]

Brief Summary:
The purpose of this study is to develop prediction models that can prognosticate patients with sarcoidosis using clinical data and blood markers that can be obtained during a clinic visit.
Detailed Description:

The purpose of this study is to develop prediction models that can prognosticate patients with sarcoidosis using clinical data and biological markers that can be obtained during a clinic visit.

Primary Aim/Objective The primary objective of this study is to determine which clinical features measured during a routine clinic visit are risk factors for progression of pulmonary sarcoidosis over the follow-up period in adults with pulmonary sarcoidosis.

Secondary Aim/Objectives The secondary objective is to determine if blood biomarkers measured during a routine clinic visit can improve the risk assessment for progression of pulmonary sarcoidosis over the follow-up period.

The investigators will measure two types of blood markers to achieve this goal:

  • Clinically available blood markers that are available in most clinical labs
  • Blood proteins and gene expression that reflect interferon inflammation and are not currently available as tests in clinical labs

 

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Abatacept in Immune Checkpoint Inhibitor Myocarditis

Status: Recruiting

Location: "Beth Israel Deaconess Medical Center ", Allegheny-Singer Research Institution, Aurora St. Luke's Medical Center, Boston Medical Center, Brigham and Women's Hospital, Cedars-Sinai Medical Center, Cleveland Clinic, Columbia University Medical Center, Franciscan Health, Johns Hopkins University, Lehigh Valley Health Network, MD Anderson Cancer Center, Maine Health, Massachusetts General Hospital, Mayo Clinic, MedStar Health Research Institute - Georgetown University, Memorial Sloan Kettering Cancer Center, Moffitt Cancer Center, Robert Wood Johnson University Hospital, University of California Los Angeles, University of Chicago, University of Kansas Medical Center, University of Kentucky, University of Michigan, University of North Carolina Chapel Hill, University of Pennsylvania, University of Texas Southwestern, University of Utah, University of West Virginia

Conditions: "Beth Israel Deaconess Medical Center ", Allegheny-Singer Research Institution, Aurora St. Luke's Medical Center, Boston Medical Center, Brigham and Women's Hospital, Cedars-Sinai Medical Center, Cleveland Clinic, Columbia University Medical Center, Franciscan Health, Johns Hopkins University, Lehigh Valley Health Network, MD Anderson Cancer Center, Maine Health, Massachusetts General Hospital, Mayo Clinic, MedStar Health Research Institute - Georgetown University, Memorial Sloan Kettering Cancer Center, Moffitt Cancer Center, Robert Wood Johnson University Hospital, University of California Los Angeles, University of Chicago, University of Kansas Medical Center, University of Kentucky, University of Michigan, University of North Carolina Chapel Hill, University of Pennsylvania, University of Texas Southwestern, University of Utah, University of West Virginia

City/State:

Los Angeles, California

Kansas City, Kansas

Lexington, Kentucky

Boston, Massachusetts

Ann Arbor, Michigan

New York, New York

Chapel Hill, North Carolina

Bethlehem, Pennsylvania

Dallas, Texas

Houston, Texas

Salt Lake City, Utah

Washington D.C.

Tampa, Florida

Chicago, Illinois

Indianapolis, Indiana

Portland, Maine

Baltimore, Maryland

Rochester, Minnesota

New Brunswick, New Jersey

Cleveland, Ohio

Philadelphia, Pennsylvania

Pittsburgh, Pennsylvania

Morgantown, West Virginia

Milwaukee, Wisconsin

Contact Information:

Hannah K Gilman, MS
6177261019
[email protected]

Brief Summary:
The primary aim is to test whether abatacept, as compared to placebo, is associated with a reduction in major adverse cardiac events (MACE) among participants hospitalized with myocarditis secondary to an immune checkpoint inhibitor (ICI). The primary outcome, MACE, is a composite of first occurrence of cardiovascular death, non-fatal sudden cardiac arrest, cardiogenic shock, significant ventricular arrythmias, significant bradyarrythmias, or incident heart failure.
Detailed Description:

This investigator-initiated randomized trial is being conducted to test whether abatacept, as compared to placebo, is associated with a reduction in MACE among participants who develop myocarditis after treatment with an ICI. Immune checkpoint inhibitors leverage the immune system to treat a wide variety of cancers. Myocarditis is an uncommon immune related adverse event (irAE) secondary to treatment with an ICI. The guideline recommended treatment for ICI myocarditis is cessation of the ICI and administration of corticosteroids. However, despite administration of corticosteroids, the rate of MACE with ICI myocarditis is high. Data from multiple independent international cohorts have shown that the rate of MACE with ICI myocarditis despite administration of corticosteroids ranges from 25-50%.For comparison, the rate of MACE with myocarditis unrelated to an ICI is <5%.

Abatacept is a selective co-stimulation modulator that inhibits T cell (T lymphocyte) activation by binding to CD80 and CD86, thereby blocking its interaction with CD28. This interaction provides a costimulatory signal necessary for full activation of T lymphocytes. In animal studies of ICI myocarditis, the administration of abatacept led to a reduction in cardiac immune activation and an increase in survival. In retrospective unpublished clinical data, the administration of abatacept to participants with ICI myocarditis on corticosteroids was associated with a reduction in risk of MACE. There are no prospective studies testing whether abatacept is effective among participants with ICI myocarditis. Therefore, the primary aim of this trial is to test in a randomized double-blind placebo-controlled study whether abatacept, administered concurrently with corticosteroids, is associated with a reduction in MACE among participants with recently diagnosed ICI myocarditis

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