The TOGETHER Project - Liver

Liver Transplant Rejection Clinical Trial

— TOGETHER  

Official title:

The Together Project-Transplant Organ Genomics to Help Prevent Rejection in Liver Transplant Recipients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03874286
• Other study ID #: IRB# 16-006453
• Status: Completed
• Start date: March 15, 2017
• Est. completion date: April 30, 2020

Study information

• Verified date: May 2022
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: April 30, 2020
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Liver Transplant Rejection

Intervention

Diagnostic Test:
• Liver Transplant
Patients will obtain a research blood draw and a liver biopsy at 4 months and 12 months post transplant. Liver biopsies are routinely performed in the liver transplant population. We will be obtaining a liver biopsy at this particular time point to compare the biopsy results with the peripheral blood results.

Locations

Country	Name	City	State
United States	Mayo Clinic	Jacksonville	Florida
United States	Mayo Clinic	Phoenix	Arizona
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To validate the use of a RNAseq-based peripheral blood assay in liver transplant recipients when correlated to liver biopsy results.	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.	3 years
Secondary	To validate the use of a RNAseq-based peripheral blood assay in liver transplant recipients when correlated to liver biopsy results.	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.	3 years

External Links

•   Mayo Clinic Clinical Trials