Non-Invasive Method of Diagnosing Rejection for Liver Transplant Patients

Overview

  • Study type

    Observational
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Scottsdale/Phoenix, Arizona: 16-006453
    • Jacksonville, Florida: 16-006453
    • Rochester, Minnesota: 16-006453
    Sponsor Protocol Number: 16-006453

About this study

The purpose of this study is to validate the use of a RNAseq-based peripheral blood assay in liver transplant recipients when correlated to liver biopsy results.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

Patients who meet all of the following criteria are eligible for enrollment as study participants:

  1. Adult ( ≥ 18 years) liver transplant recipient.
  2. Patients who have given informed consent and are willing to comply with the protocol, including the use of their peripheral blood specimens and data for subsequent research.
  3. Patients with increased risk of rejection. Patients must meet at least one of the following criteria:
    1. Autoimmune etiology of the original liver disease (autoimmune hepatitis, primary biliary cirrhosis or primary sclerosing cholangitis)
    2. Recipients of donation-after-cardiac death (DCD) donors
    3. Recipients of simultaneous liver-kidney transplantation
    4. Positive crossmatch liver transplant (T cell flow crossmatch or B cell flow crossmatch).
    5. Patients who underwent liver transplantation for PSC in the past, with recurrent disease (total of 4 patients)
    6. Patients who underwent liver transplantation for NASH (nonalcoholic steatohepatitis).
    7. Patients who have a BMI ≥ 35.

Exclusion Criteria

Patients who meet any of these criteria are not eligible for enrollment as study participants:

  1. Adult ( ≥ 18 years) renal transplant recipient.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Mark Stegall, M.D.

Open for enrollment

Contact information:

Samantha Parker

(480)342-6677

Parker.Samantha@mayo.edu

Jacksonville, Fla.

Mayo Clinic principal investigator

Mark Stegall, M.D.

Open for enrollment

Contact information:

Joel Espinoza

(904)953-8855

Espinoza.Joel@mayo.edu

Rochester, Minn.

Mayo Clinic principal investigator

Mark Stegall, M.D.

Open for enrollment

Contact information:

Kristina McManimon

(507)255-3782

McManimon.Kristina@mayo.edu