Molecular Assessment and Profiling of Liver Transplant Recipients
MAPLE
1 other identifier
observational
1,500
1 country
26
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2021
Longer than P75 for all trials
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 8, 2021
CompletedFirst Posted
Study publicly available on registry
March 11, 2021
CompletedStudy Start
First participant enrolled
May 26, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 31, 2028
February 23, 2026
February 1, 2026
6.6 years
March 8, 2021
February 20, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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)
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'
2 years of accrual and 3 years follow up
Study Arms (1)
LiverCare Surveillance
Participants undergoing orthotopic liver transplant (de-novo or re-transplant) will be considered for this study
Interventions
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.
Eligibility Criteria
All liver transplant patients without exclusion criteria will be eligible to enter the study. Patients will be approached by the study team at the time of transplant or within 60 days post-transplant to discuss the trial, consent and enrollment.
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CareDxlead
Study Sites (26)
Keck Medical Center of USC
Los Angeles, California, 90033, United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007, United States
Tampa General Hospital
Tampa, Florida, 33606, United States
Piedmont Healthcare
Atlanta, Georgia, 30309, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Tulane University
New Orleans, Louisiana, 70112, United States
University of Maryland Medical Center
Baltimore, Maryland, 21201, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Beth Israel Deaconess Medical Center (BIDMC)
Boston, Massachusetts, 02215, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Washington Unversity in St. Louis
St Louis, Missouri, 63110, United States
University of Nebraska Medical Center/ Nebraska Medicine
Omaha, Nebraska, 68198, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
Westchester Medical Center
Valhalla, New York, 10595, United States
Atrium Health
Charlotte, North Carolina, 28204, United States
Duke University
Durham, North Carolina, 27710, United States
University of Cincinnati
Cincinnati, Ohio, 45267, United States
INTEGRIS Baptist Medical Center
Oklahoma City, Oklahoma, 73112, United States
Medical Unversity of South Carolina
Charleston, South Carolina, 29425, United States
University of Tennessee_Methodist Healthcare
Memphis, Tennessee, 38104, United States
Methodist Health System
Dallas, Texas, 75203, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Intermountain Medical Center
Murray, Utah, 84107, United States
Virginia Commonwealth University
Richmond, Virginia, 23219, United States
University of Washington
Seattle, Washington, 98195, United States
Study Officials
- STUDY DIRECTOR
Kanish Mohib, PhD
CareDx
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 8, 2021
First Posted
March 11, 2021
Study Start
May 26, 2021
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
March 31, 2028
Last Updated
February 23, 2026
Record last verified: 2026-02