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
|Condition or disease||Intervention/treatment||Phase|
|Liver Transplant Rejection||Diagnostic Test: Liver Transplant||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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.
- 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.
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
|Contact: Leah M Majerusemail@example.com|
|Contact: Nong Yowe Braatenfirstname.lastname@example.org|
|United States, Arizona|
|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|
|Jacksonville, Florida, United States, 32224|
|Contact: Joel A. Espinoza 904-783-8855 email@example.com|
|Principal Investigator: Kristopher P Croome, MD|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Contact: Leah M Majerus 507-255-3940 firstname.lastname@example.org|
|Contact: Nong Yowe Braaten 507-538-9617 email@example.com|
|Principal Investigator: Mark D Stegall, M.D.|