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ACTIVE NOT RECRUITING
NCT04793360

Molecular Assessment and Profiling of Liver Transplant Recipients

Sponsor: CareDx

View on ClinicalTrials.gov

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

Interventions

DEVICE

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