Analyzing donor DNA in liver transplant patients
Retrospective Exploratory Analysis of Donor-derived Cell Free DNA in Liver Transplant Patients
This study is testing if measuring donor DNA in the blood of liver transplant patients can help doctors see if they're getting the right amount of medication to prevent organ rejection.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Methodist Health System Academic / other |
| Locations | 1 site (Dallas, Texas) |
| Trial ID | NCT06225206 on ClinicalTrials.gov |
What this trial studies
This observational study aims to measure donor-derived cell-free DNA (dd-cfDNA) levels in liver transplant recipients who have stable liver function tests. By assessing these levels, the study seeks to determine whether patients are receiving the appropriate amount of immunosuppression medication. This non-invasive method could provide a more accurate way to monitor graft function compared to traditional liver biopsies. The ultimate goal is to optimize immunosuppression regimens and identify potential rejection early.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have undergone a liver transplant and have documented levels of donor-derived cell-free DNA.
Not a fit: Patients who have not undergone a liver transplant or do not have documented levels of dd-cfDNA will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more personalized and effective immunosuppression management for liver transplant patients.
How similar studies have performed: While the use of dd-cfDNA in other transplant settings has shown promise, this specific application in liver transplant patients is relatively novel and untested.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Dallas, Texas
- Methodist Dallas Medical Center — Dallas, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Parvez Mantry, MD — Methodist Midlothian Medical Center
- Study coordinator: Kavya Vinod Mankulangara, PharmD
- Email: MHSIRB@mhd.com
- Phone: 214-947-4681
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.