Clinical Trial

Molecular Assessment and Profiling of Liver Transplant Recipients

Study acronym: MAPLE
Active, Not Recruiting
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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.
Protocol Amendment History 15 amendments
This ClinicalTrials.gov record has been amended 15 times since 2021-03-09; most recent amendment 2026-02-20.
Status change: Recruiting → Active, Not Recruiting 2024-04-30
Status change: Not Yet Recruiting → Recruiting 2021-06-03
Trial Details
NCT Number NCT04793360
Lead Sponsor CareDx
Conditions Liver Transplantation, Biomarkers
Enrollment 1,500 participants
Start Date 2021-05-26
Primary Completion 2027-12-31 (estimated)
Study Completion 2028-03-31 (estimated)
Updated on ClinicalTrials.gov 2026-02-23