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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Liver Transplant Failure
• Intervention / Treatment: Behavioral: donor-derived cell free DNA in liver

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 Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Bethany Brauer, MPH; Phone Number: 214-947-4681; Email: mhsirb@mhd.com
• Study Contact Backup: Name: Kavya Vinod Mankulangara, PharmD; Phone Number: 214-947-4681; Email: MHSIRB@mhd.com

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75203
      • Recruiting
      • Methodist Dallas Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients included in the study should be at least 18 years of age, who have underwent a liver transplant and at least have one level of dd-cfDNA documented.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
dd-cfDNA range in liver transplant patients	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.	1 year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Methodist Health System
• Investigators: Principal Investigator: Parvez Mantry, MD, Methodist Midlothian Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: November 13, 2023
• First Submitted That Met QC Criteria: January 16, 2024
• First Posted (Actual): January 25, 2024

Study Record Updates

• Last Update Posted (Actual): March 28, 2024
• Last Update Submitted That Met QC Criteria: March 26, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 023.HEP.2023.D

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Study data or any protected health information will not be shared with anyone that is not delegated to the study. The PI is committed to disseminate research results in a timely fashion. Sharing of results generated by the data analysis during the course of the project will be through presentation at national scientific meetings and/or publication in open access journals
• IPD Sharing Time Frame: 2 years

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No