Analysis of Donor-derived Cell Free DNA in Liver Transplant Patients

Recruiting

• Conditions: Liver Transplant Failure

• Registration Number: NCT06225206
• Lead Sponsor: Methodist Health System

Brief Summary

Determine the levels of Donor-derived (dd)cell-free DNA(cfDNA )in liver transplant recipients with normal liver function tests (LFTs) indicating stable immunosuppression status (IS). Based on this range use the dd-cfDNA levels to determine over or under IS in liver transplant patients to make changes to their IS medication regimen.

Detailed Description

dd-cfDNA is a non-invasive method to measure graft function stability in liver transplant patients. Liver biopsy is the standard to determine liver rejection and graft function, but no tests exist currently to be able to help guide the IS regimen in these patients. LFTs are not as specific to determine graft function hence testing dd-cfDNA levels can help guide the Immunosuppression (IS )medications dosing and help identify rejection early.

Study Timeline

• Study Start: 2021-07-01
• Study First Submitted: 2023-11-13
• Status Verified: 2024-01
• Study First Submitted QC: 2024-01-16
• Study First Posted: 2024-01-25
• Last Update Submitted: 2024-03-26
• Last Update Posted: 2024-03-28
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1. Age: ≥18 years
2. The patient underwent a liver transplant.
3. The patient at least has one level of dd-cfDNA documented

Exclusion Criteria

• Patient not meeting the inclusion criteria will be excluded.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
dd-cfDNA range in liver transplant patients	1 year	Determine the dd-cfDNA in liver transplant patients with stable IS collected from July 2021 to July 2024 and compare the range between patients with \<1-year post-transplant (PTX) and \>1-year PTX by chart review using Methodist hospital data system.

Secondary Outcome Measures

Name	Time	Method
LFTs: Alanine transaminase(ALT), Aspartate transaminase(AST),Alkaline phosphatase( ALP), total bilirubin (Tbili)	1 year	looking at the liver function tests in patients who underwent liver transplant less than 1 year of PTX and more than 1 year PTX
Days post-transplant at first dd-cfDNA	1 year	Number of days post transplant at first dd-cfDNA
Serum Creatinine	1 year	Measuring the serum creatinine levels
Demographics: age (years), gender (male/female), race (Caucasian, Black, Hispanic, Asian, Other)	1 year	Demographics differences in patients who underwent liver transplant less than 1 year of PTX and more than 1 year PTX

Trial Locations

Locations (1)

Methodist Dallas Medical Center; 🇺🇸 Dallas, Texas, United States