Analysis of Donor-derived Cell Free DNA in Liver Transplant Patients
Retrospective Exploratory Analysis of Donor-derived Cell Free DNA in Liver Transplant Patients
1 other identifier
observational
300
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2021
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2021
CompletedFirst Submitted
Initial submission to the registry
November 13, 2023
CompletedFirst Posted
Study publicly available on registry
January 25, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedMarch 28, 2024
January 1, 2024
3.5 years
November 13, 2023
March 26, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Demographics: age (years), gender (male/female), race (Caucasian, Black, Hispanic, Asian, Other)
1 year
Days post-transplant at first dd-cfDNA
1 year
LFTs: Alanine transaminase(ALT), Aspartate transaminase(AST),Alkaline phosphatase( ALP), total bilirubin (Tbili)
1 year
Serum Creatinine
1 year
Interventions
Determine the difference in age, gender, LFTs, IS regimen (tacrolimus/sirolimus/cyclosporin with mycophenolate mofetil (MMF) and /or prednisone) between patients who underwent liver transplant \<1 year PTX and \>1 year PTX
Eligibility Criteria
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.
You may qualify if:
- Age: ≥18 years
- The patient underwent a liver transplant.
- The patient at least has one level of dd-cfDNA documented
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Methodist Dallas Medical Center
Dallas, Texas, 75203, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Parvez Mantry, MD
Methodist Midlothian Medical Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 13, 2023
First Posted
January 25, 2024
Study Start
July 1, 2021
Primary Completion
December 31, 2024
Study Completion
December 31, 2024
Last Updated
March 28, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- 2 years
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