The TOGETHER Project - Liver
TOGETHER
The Together Project-Transplant Organ Genomics to Help Prevent Rejection in Liver Transplant Recipients
1 other identifier
observational
54
1 country
3
Brief Summary
To validate the use of a RNAseq-based peripheral blood assay in liver transplant recipients when correlated to liver biopsy results.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Mar 2017
Typical duration for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 15, 2017
CompletedFirst Submitted
Initial submission to the registry
March 12, 2019
CompletedFirst Posted
Study publicly available on registry
March 14, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2020
CompletedMay 20, 2022
May 1, 2022
3.1 years
March 12, 2019
May 19, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
To validate the use of a RNAseq-based peripheral blood assay in liver transplant recipients when correlated to liver biopsy results.
3 years
Study Arms (1)
Liver Transplant
Participants will obtain a liver biopsy at 4 months post transplant and 12 months post transplant.
Interventions
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.
Eligibility Criteria
Adult liver transplant recipients with diverse demographics (e.g. recipient race and donor type) and treatment strategies (induction, steroid-free, etc.).
You may qualify if:
- 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).
You may not qualify if:
- Adult ( ≥ = 18 years) renal transplant recipient.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (3)
Mayo Clinic
Phoenix, Arizona, 85054, United States
Mayo Clinic
Jacksonville, Florida, 32224, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Related Links
Biospecimen
Any unused specimens will be destroyed or stored at Mayo Clinic. Peripheral blood obtained under this protocol may be used in future assays to reevaluate biological responses as additional research tests are developed or refined over time. Samples may be used to look at genetic information in relation to liver transplantation (for example, the rejection process). However, samples could also be used in studies that are not related to transplantation (for example, the immune system as a whole). Specimens will not be stored for longer than 15 years after the closure of the study. Appropriate informed consent will be obtained for both the collection and storage of samples. Any future research identified will be reviewed and approved by an Institutional Review Board.
Study Officials
- PRINCIPAL INVESTIGATOR
Mark Stegall, MD
Mayo Clinic
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 12, 2019
First Posted
March 14, 2019
Study Start
March 15, 2017
Primary Completion
April 30, 2020
Study Completion
April 30, 2020
Last Updated
May 20, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share