NCT04793360

Molecular Assessment and Profiling of Liver Transplant Recipients

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,500 (estimated)
• Sponsor: CareDx · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Liver Transplantation
• Biomarkers

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-05-26
• Primary completion: 2027-12-31
• Completion: 2028-03-31
• First posted: 2021-03-11
• Last updated: 2026-02-23

Locations

26 sites across 1 country: United States