The TOGETHER Project - Liver

Completed

• Conditions: Liver Transplant Rejection
• Interventions: Diagnostic Test: Liver Transplant

• Registration Number: NCT03874286
• Lead Sponsor: Mayo Clinic

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2017-03-15
• Study First Submitted: 2019-03-12
• Study First Submitted QC: 2019-03-12
• Study First Posted: 2019-03-14
• Primary Completion: 2020-04-30
• Study Completion: 2020-04-30
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-19
• Last Update Posted: 2022-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Liver Transplant	Liver Transplant	Participants will obtain a liver biopsy at 4 months post transplant and 12 months post transplant.

Primary Outcome Measures

Name	Time	Method
To validate the use of a RNAseq-based peripheral blood assay in liver transplant recipients when correlated to liver biopsy results.	3 years	The primary endpoint for this study is defined as obtaining the results of the RNAseq testing and to determine if an assay for rejection can be developed.

Secondary Outcome Measures

Name	Time	Method
To validate the use of a RNAseq-based peripheral blood assay in liver transplant recipients when correlated to liver biopsy results.	3 years	The secondary endpoint for this study is defined as obtaining the results of the RNAseq testing and to ascertain whether an assay for detection of disease recurrence can be developed.

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States