Donor-Derived Cell-Free DNA: A Breakthrough Biomarker for Early Rejection Detection and Immunosuppression Management in Liver Transplant Patients

DONOR-DERIVED CIRCULATING CELL-FREE DNA AS A REJECTION BIOMARKER AND IMMUNOSUPPRESSION MODULATION TOOL IN LIVER TRANSPLANTATION - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/02/080893

Enrollment

136

Registered

2025-02-19

Start date

Unknown

Completion date

Unknown

Last updated

2025-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: donor-derived cell-free DNA and liver function tests: Blood samples (9 ml) were collected on postoperative days 3, 7, 14, 30, and 90, and dd-cfDNA was quantified. If dd-cfDNA levels wer

Eligibility

Inclusion criteria

Inclusion criteria: All adults admitted to undergo liver transplantation

Exclusion criteria

Exclusion criteria: Multi-organ transplantation, identical twin donor and recipient, ABO-incompatible transplantation

Design outcomes

Primary

Measure	Time frame
Primary Outcome: Efficacy of dd-cfDNA in indicating adequate immunosuppression levels Timepoint: Post-operative day 3, 7, 14,30 and 90	—

Secondary

Measure	Time frame
a) Early detection of allograft rejection compared to liver function tests.Timepoint: Post-operative day3,7,14,30 and 90;b) Correlation of Granzyme-B levels and antibody mediated rejectionTimepoint: Post-operative day 3,7,14,30 and 90;c)Comparison of graft morphology 1-year post-transplant in both groupsTimepoint: 1-year post-transplantation	—

Countries

India

Contacts

Public ContactDr. Lakshmi.V.U

Amrita Institute of Medical Sciences and Research Centre: Amrita Institute of Medical Sciences

sudhisalini@icloud.com7306716242

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026