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TGI: Using Transcriptional Assessment of Immune Response to Assess Immunosuppression After Liver Transplantation

Sponsor
University of Florida (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06063213
Collaborator
Transplant Genomics, Inc. (Industry)
40
Enrollment
24
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

To develop a prospective quantitative liver allograft monitoring protocol and retrospectively validate the use of Phenotypic personalized medicine (PPM) in immunosuppression dosing in liver transplant recipients.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    40 participants
    Observational Model:
    Cohort
    Time Perspective:
    Other
    Official Title:
    Using Transcriptional Assessment of Immune Response to Assess Immunosuppression After Liver Transplantation
    Anticipated Study Start Date :
    Sep 25, 2023
    Anticipated Primary Completion Date :
    Sep 25, 2025
    Anticipated Study Completion Date :
    Sep 25, 2025

    Arms and Interventions

    Arm Intervention/Treatment
    Liver Transplant Group

    Patients <1 month post-surgery for liver transplant only.
    Liver-Kidney Transplant Group

    Patients <1 month post-surgery for simultaneous kidney-liver transplant only.

    Outcome Measures

    Primary Outcome Measures

    1. Improve Allograft outcomes in solid organ transplantation [2 years]

      Prospective collection of quantitative markers of allograft injury and immune function in liver transplant recipients to compare changes in scores with standard of care clinical measures of organ function and injury

    2. Retrospective validation of PPM use in immunosuppression dosing in liver transplant recipients [2 years]

      Retrospective application of PPM to quantitative markers of allograft injury and immune function to identify the critical determinants of response to immunosuppression by including biomarkers

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • At least 18 years of age

    • At least one-month post-transplant

    • Recipient of a liver transplant alone or a simultaneous liver-kidney transplant

    Exclusion Criteria:

    • Unwilling to provide informed consent

    • Recipient of a previous bone marrow or stem cell transplant

    • Pregnant

    • Unlikely to be able to comply with the study requirements, as determined by the PI

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University of Florida
    • Transplant Genomics, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Florida
    ClinicalTrials.gov Identifier:
    NCT06063213
    Other Study ID Numbers:
    • IRB202300021
    First Posted:
    Oct 2, 2023
    Last Update Posted:
    Oct 2, 2023
    Last Verified:
    Sep 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Oct 2, 2023