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The TOGETHER Project - Liver (TOGETHER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03874286
Recruitment Status : Active, not recruiting
First Posted : March 14, 2019
Last Update Posted : May 19, 2021
Sponsor:
Information provided by (Responsible Party):
Mark Stegall, Mayo Clinic

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

Condition or disease Intervention/treatment
Liver Transplant Rejection Diagnostic Test: Liver Transplant

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 Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Together Project-Transplant Organ Genomics to Help Prevent Rejection in Liver Transplant Recipients
Actual Study Start Date : March 15, 2017
Estimated Primary Completion Date : March 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Liver Transplant
Participants will obtain a liver biopsy at 4 months post transplant and 12 months post transplant.
 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.
Other Name: Liver biopsy


Outcome Measures
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Primary Outcome Measures :
  1. To validate the use of a RNAseq-based peripheral blood assay in liver transplant recipients when correlated to liver biopsy results. [ Time Frame: 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 :
  1. To validate the use of a RNAseq-based peripheral blood assay in liver transplant recipients when correlated to liver biopsy results. [ Time Frame: 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.


Biospecimen Retention:   Samples With DNA

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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult liver transplant recipients with diverse demographics (e.g. recipient race and donor type) and treatment strategies (induction, steroid-free, etc.).
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03874286


Locations
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United States, Arizona
Mayo Clinic
Phoenix, Arizona, United States, 85054
United States, Florida
Mayo Clinic
Jacksonville, Florida, United States, 32224
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Mark Stegall, MD Mayo Clinic
More Information
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Additional Information:

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Responsible Party: Mark Stegall, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03874286    
Other Study ID Numbers: IRB# 16-006453
First Posted: March 14, 2019    Key Record Dates
Last Update Posted: May 19, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mark Stegall, Mayo Clinic:
Liver Transplant
Additional relevant MeSH terms:
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Liver Extracts
Hematinics