Molecular Assessment and Profiling of Liver Transplant Recipients

Active, not recruiting

• Conditions: Liver Transplantation; Biomarkers

• Registration Number: NCT04793360
• Lead Sponsor: CareDx

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-08
• Study First Submitted QC: 2021-03-09
• Study First Posted: 2021-03-11
• Study Start: 2021-05-26
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-10
• Last Update Posted: 2025-04-11
• Primary Completion: 2027-12-31
• Study Completion: 2028-03-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1500

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Locations

Locations (26)

Baylor College of Medicine; 🇺🇸 Houston, Texas, United States

Keck Medical Center of USC; 🇺🇸 Los Angeles, California, United States

MedStar Georgetown University Hospital; 🇺🇸 Washington, 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

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