Molecular Assessment and Profiling of Liver Transplant Recipients (MAPLE)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Liver Transplantation; Biomarkers
• Intervention / Treatment: Device: LiverCare

• Study Type: Observational
• Enrollment (Estimated): 1500

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90033
      • Keck Medical Center of USC
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20007
      • MedStar Georgetown University Hospital
  • Florida
    • Tampa, Florida, United States, 33606
      • Tampa General Hospital
  • Georgia
    • Atlanta, Georgia, United States, 30309
      • Piedmont Healthcare
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Tulane University
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center (BIDMC)
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health System
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Washington Unversity in St. Louis
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • University of Nebraska Medical Center/ Nebraska Medicine
  • New York
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai
    • Valhalla, New York, United States, 10595
      • Westchester Medical Center
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Atrium Health
    • Durham, North Carolina, United States, 27710
      • Duke University
  • Ohio
    • Cincinnati, Ohio, United States, 45267
      • University of Cincinnati
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Integris Baptist Medical Center
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical Unversity of South Carolina
  • Tennessee
    • Memphis, Tennessee, United States, 38104
      • University of Tennessee_Methodist Healthcare
  • Texas
    • Dallas, Texas, United States, 75203
      • Methodist Health System
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine
  • Utah
    • Murray, Utah, United States, 84107
      • Intermountain Medical Center
  • Virginia
    • Richmond, Virginia, United States, 23219
      • Virginia Commonwealth University
  • Washington
    • Seattle, Washington, United States, 98195
      • University of Washington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

LiverCare Surveillance; Participants undergoing orthotopic liver transplant (de-novo or re-transplant) will be considered for this study

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: CareDx
• Investigators: Study Director: Kanish Mohib, PhD, CareDx

Study record dates

Study Major Dates

• Study Start (Actual): May 26, 2021
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): March 31, 2028

Study Registration Dates

• First Submitted: March 8, 2021
• First Submitted That Met QC Criteria: March 9, 2021
• First Posted (Actual): March 11, 2021

Study Record Updates

• Last Update Posted (Actual): February 23, 2026
• Last Update Submitted That Met QC Criteria: February 20, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: SN-C-00015

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No