Molecular Assessment and Profiling of Liver Transplant Recipients

NCT04793360 · tracked via the Priya Life Science USA tracker

Sponsor

CareDx

Phase

Observational

Started

2021-05-26

Last updated

2026-09-03

Condition(s) studied

Liver TransplantationBiomarkers

Investigational drug(s) / intervention(s)

LiverCare

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.

Study 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.

Eligibility

Sex

ALL

Min age

12 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Primary outcome measure(s)

To correlate the results of LiverCare with clinically significant events impacting post-transplant clinical outcomes, histological findings, and the development of de novo Donor Specific Antibody (DSA) — 2 years of accrual and 3 years follow up
LiverCare will be measured 7 times in year 1 and quarterly each year. A total of 15 surveillance points per subject in addition to for-cause testing based on clinical changes. Liver care will be collected at the time of all histologic analyses whether 'for cause' or 'surveillance'

Trial sites (26)

Facility	City	Region
Keck Medical Center of USC	Los Angeles	California
MedStar Georgetown University Hospital	Washington D.C.	District of Columbia
Tampa General Hospital	Tampa	Florida
Piedmont Healthcare	Atlanta	Georgia
University of Kansas Medical Center	Kansas City	Kansas
Tulane University	New Orleans	Louisiana
University of Maryland Medical Center	Baltimore	Maryland
Massachusetts General Hospital	Boston	Massachusetts
Beth Israel Deaconess Medical Center (BIDMC)	Boston	Massachusetts
University of Michigan	Ann Arbor	Michigan
Henry Ford Health System	Detroit	Michigan
Washington Unversity in St. Louis	St Louis	Missouri
University of Nebraska Medical Center/ Nebraska Medicine	Omaha	Nebraska
Icahn School of Medicine at Mount Sinai	New York	New York
Westchester Medical Center	Valhalla	New York
Atrium Health	Charlotte	North Carolina
Duke University	Durham	North Carolina
University of Cincinnati	Cincinnati	Ohio
INTEGRIS Baptist Medical Center	Oklahoma City	Oklahoma
Medical Unversity of South Carolina	Charleston	South Carolina
University of Tennessee_Methodist Healthcare	Memphis	Tennessee
Methodist Health System	Dallas	Texas
Baylor College of Medicine	Houston	Texas
Intermountain Medical Center	Murray	Utah
Virginia Commonwealth University	Richmond	Virginia
University of Washington	Seattle	Washington

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04793360 on ClinicalTrials.gov ↗ ← All trials in the USA