The TOGETHER Project - Liver

Mayo Clinic

Status: Completed

Conditions: Liver Transplant Rejection

Treatments: Diagnostic Test: Liver Transplant

Study type: Observational

Funder types: Other

Identifiers

NCT03874286

IRB# 16-006453

Details and patient eligibility

About

To validate the use of a RNAseq-based peripheral blood assay in liver transplant recipients when correlated to liver biopsy results.

Full description

The study is a prospective, observational study utilizing peripheral blood assays that will be collected at time points that are considered standard of care at most institutions. 100 participants will be enrolled in study. Participants will have peripheral blood collected at 4 months and 12 months after liver transplant, as well as any for cause time points. Participants will also have liver biopsies collected at these time points. The results from the liver biopsies will be used in correlation with the results from the peripheral blood assays.

Enrollment: 54 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• 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.

• 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).

     Exclusion Criteria:

• Adult ( ≥ = 18 years) renal transplant recipient.

Trial design

54 participants in 1 patient group

Liver Transplant

Description:

Participants will obtain a liver biopsy at 4 months post transplant and 12 months post transplant.

Treatment:

Diagnostic Test: Liver Transplant