The TOGETHER Project - Liver

Study Overview
=================
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.

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

Conditions
-----------------
Liver Transplant Rejection

Intervention / Treatment
-----------------
* Diagnostic Test: Liver Transplant


Participation Criteria
=================
Eligibility 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: Autoimmune etiology of the original liver disease (autoimmune hepatitis, primary biliary cirrhosis or primary sclerosing cholangitis) Recipients of donation-after-cardiac death (DCD) donors Recipients of simultaneous liver-kidney transplantation Positive crossmatch liver transplant (T cell flow crossmatch or B cell flow crossmatch). Exclusion Criteria: Adult ( ≥ = 18 years) renal transplant recipient.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Liver Transplant<br>Participants will obtain a liver biopsy at 4 months post transplant and 12 months post transplant. | Diagnostic Test: Liver Transplant<br>* 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.<br>* Other names: Liver biopsy;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Liver Transplant