Utility of Donor-Derived Cell Free DNA in Association With Gene Expression Profiling

Completed

Conditions studied: Cardiac Transplant Failure, Cardiac Transplant Rejection, Heart Diseases

In brief

Plasma donor-derived cell-free DNA (dd-cfDNA) is measured as a % of the total plasma cfDNA in association with the measurement of AlloMap, a non-invasive gene expression test to aid in heart transplant management.

Key facts

Study ID

NCT02178943

Run by

CareDx

People needed

100

Starts

2014-06-01

Expected to finish

2020-02-01

Last updated by the study team

2024-10-29

Who can join

Age: 15 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Any heart transplant recipient eligible for initiation and participation in the Outcomes AlloMap Registry (OAR) Study of regular AlloMap testing.
• Patients can be enrolled any time as long as they have not had more than 1 prior AlloMap.
• Written informed consent must be obtained prior to study enrollment. Exclusion Criteria
• Pregnant Women.

Where it is running

• Cedars-Sinai Medical Center — Beverly Hills, California, United States
• University of California, Los Angeles — Los Angeles, California, United States
• Stanford University — Stanford, California, United States
• Memorial Regional Hospital — Hollywood, Florida, United States
• Tampa General Hospital — Tampa, Florida, United States
• Emory University — Atlanta, Georgia, United States
• University of Chicago — Chicago, Illinois, United States
• St. Vincent Medical Group — Indianapolis, Indiana, United States
• University of Kentucky — Lexington, Kentucky, United States
• Ochsner Clinic Foundation — New Orleans, Louisiana, United States
• University of Michigan — Ann Arbor, Michigan, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• Mid America Heart Institute - St. Luke's Hospital — Kansas City, Missouri, United States
• Washington University — St Louis, Missouri, United States
• Mount Sinai Hospital — New York, New York, United States
• Columbia University Medical Center — New York, New York, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Ohio State University — Columbus, Ohio, United States
• Integris Baptist Medical Center — Oklahoma City, Oklahoma, United States
• Drexel University — Philadelphia, Pennsylvania, United States
• Allegheny General Hospital — Pittsburgh, Pennsylvania, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• Baylor Research Institute — Dallas, Texas, United States
• UT Southwestern Medical Center — Dallas, Texas, United States
• Baylor St. Lukes — Houston, Texas, United States

Full record on ClinicalTrials.gov

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