Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 4 of 14 for:    mark stegall transplant

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03874286
Recruitment Status : Recruiting
First Posted : March 14, 2019
Last Update Posted : March 14, 2019
Sponsor:
Information provided by (Responsible Party):
Mark Stegall, 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.

Condition or disease Intervention/treatment Phase
Liver Transplant Rejection Diagnostic Test: Liver Transplant Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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 : December 31, 2019
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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 biopsy's 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




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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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


Contacts
Layout table for location contacts
Contact: Leah M Majerus 507-255-3940 majerus.leah@mayo.edu
Contact: Nong Yowe Braaten 507-538-9617 braaten.nong@mayo.edu

Locations
Layout table for location information
United States, Arizona
Mayo Clinic Recruiting
Phoenix, Arizona, United States, 85054
Contact: Angela S Eyshou    480-342-3906    Eyshou.Angela@mayo.edu   
Principal Investigator: Adyr A Moss, MD         
United States, Florida
Mayo Clinic Recruiting
Jacksonville, Florida, United States, 32224
Contact: Joel A. Espinoza    904-783-8855    espinoza.joel@mayo.edu   
Principal Investigator: Kristopher P Croome, MD         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Leah M Majerus    507-255-3940    majerus.leah@mayo.edu   
Contact: Nong Yowe Braaten    507-538-9617    braaten.nong@mayo.edu   
Principal Investigator: Mark D Stegall, M.D.         
Sponsors and Collaborators
Mayo Clinic

Additional Information:
Layout table for additonal information
Responsible Party: Mark Stegall, Dr. Mark Stegall, James C. Masson Professor of Surgery Research, Director, Transplant Immunology Laboratory, Departments of Surgery and Immunology, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03874286     History of Changes
Other Study ID Numbers: IRB# 16-006453
First Posted: March 14, 2019    Key Record Dates
Last Update Posted: March 14, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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:
Layout table for MeSH terms
Liver Extracts
Hematinics