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Molecular Assessment and Profiling of Liver Transplant Recipients
Sponsor: CareDx
Summary
The objective of this protocol is to conduct longitudinal and prospective studies of liver transplant recipients, using a multimodality approach, akin to that used in kidney transplantation. The primary aim will compare the clinical outcomes of LiverCare post-transplant surveillance in liver transplant with standard of care consisting of liver function tests, DSA measurements, drug level monitoring, and 'for cause' biopsy. The protocol will assess the correlation between clinical events (e.g. rejection, recurrent disease, biliary obstruction), dd-cfDNA levels, gene expression profiling, ability to assess microchimerism, develop predictive analytics, infectious disease diagnoses and finally examine graft histology.
Key Details
Gender
All
Age Range
12 Years - Any
Study Type
OBSERVATIONAL
Enrollment
1500
Start Date
2021-05-26
Completion Date
2028-03-31
Last Updated
2026-02-23
Healthy Volunteers
No
Conditions
Interventions
LiverCare
The LiverCare kits contains Streck tubes and PAX gene tubes, which will be collected at the surveillance schedule outlined above, but also prior to any liver biopsy or DSA measurement. For patients who have a histological diagnosis of allograft rejection who are undergoing treatment, serial monitoring of LiverCare will be performed following the schedule above. All research blood tests will be timed with standard clinical testing to avoid any additional needle sticks.
Locations (26)
Keck Medical Center of USC
Los Angeles, California, United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States
Tampa General Hospital
Tampa, Florida, United States
Piedmont Healthcare
Atlanta, Georgia, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Tulane University
New Orleans, Louisiana, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center (BIDMC)
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Henry Ford Health System
Detroit, Michigan, United States
Washington Unversity in St. Louis
St Louis, Missouri, United States
University of Nebraska Medical Center/ Nebraska Medicine
Omaha, Nebraska, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Westchester Medical Center
Valhalla, New York, United States
Atrium Health
Charlotte, North Carolina, United States
Duke University
Durham, North Carolina, United States
University of Cincinnati
Cincinnati, Ohio, United States
INTEGRIS Baptist Medical Center
Oklahoma City, Oklahoma, United States
Medical Unversity of South Carolina
Charleston, South Carolina, United States
University of Tennessee_Methodist Healthcare
Memphis, Tennessee, United States
Methodist Health System
Dallas, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Intermountain Medical Center
Murray, Utah, United States
Virginia Commonwealth University
Richmond, Virginia, United States
University of Washington
Seattle, Washington, United States