Molecular Assessment and Profiling of Liver Transplant Recipients

Running, not enrolling

Conditions studied: Liver Transplantation, Biomarkers

In brief

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 facts

Study ID

NCT04793360

Run by

CareDx

People needed

1500

Starts

2021-05-26

Expected to finish

2028-03-31

Last updated by the study team

2026-02-23

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Liver transplant recipients <60 days post-transplant (de-novo or re-transplant).
• Participant is willing and able to give informed consent for participation in the trial.
• Male or Female, aged 12 years or above (Gillick Competent).
• In the Investigator's opinion, is able and willing to comply with all trial requirements.

You may not qualify if…

• Female participant who is pregnant, lactating or planning pregnancy during the course of the trial.
• Has evidence of significant post-transplant impairment of hepatic function which is unlikely to improve (determined by the PI).
• Scheduled elective surgery or other procedures requiring general anaesthesia during the trial.
• Participant with life expectancy of less than 6 months or is inappropriate for diagnostic monitoring through regular blood sampling.
• Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.
• Participants who have participated in another research trial involving an investigational product in the past 12 weeks*.
• Multi-organ transplant recipients or dual organ transplant recipients.
• Patients with significant needle phobia.

Where it is running

• 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

Full record on ClinicalTrials.gov

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