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

NCT ID: NCT06225206

Last Updated: 2024-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-07-01

Study Completion Date

2024-12-31

Brief Summary

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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

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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.

Conditions

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Liver Transplant Failure

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Interventions

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donor-derived cell free DNA in liver

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Methodist Health System

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Parvez Mantry, MD

Role: PRINCIPAL_INVESTIGATOR

Methodist Midlothian Medical Center

Locations

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Methodist Dallas Medical Center

Dallas, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Kavya Vinod Mankulangara, PharmD

Role: CONTACT

214-947-4681

Bethany Brauer, MPH

Role: CONTACT

214-947-4681

Other Identifiers

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023.HEP.2023.D

Identifier Type: -

Identifier Source: org_study_id

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