The TOGETHER Project - Transplant Organ Genomics to Help Prevent Rejection in Heart Transplant Recipients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Heart Transplant Rejection
- Sponsor
- Mayo Clinic
- Enrollment
- 101
- Locations
- 1
- Primary Endpoint
- RNA-seq based peripheral blood assay in heart transplant recipients
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
The researchers are trying to develop a way to measure the risk of transplant rejection with a blood test.
Detailed Description
The study will utilize peripheral blood assays collected at time points that are considered standard of care at most institutions. Subjects will have peripheral blood collected at 1 month, 3 months, 6 months, and 12 months after heart transplantation, as well as any for cause time points. These samples will then be used for purposes of developing an RNA-seq based peripheral blood assay in adult heart transplant recipients.
Investigators
Naveen L. Pereira
Principal Investigator
Mayo Clinic
Eligibility Criteria
Inclusion Criteria
- •Patients who meet all of the following criteria are eligible for enrollment as study participants:
- •Adult (≥18 years) solitary heart transplant recipient
- •Patient is willing and able to provide informed written consent
Exclusion Criteria
- •Patients who meet any of these criteria are not eligible for enrollment as study participants:
- •Adult (\<18 years) heart transplant recipient
- •Patient refusal to enroll in the studyc
- •Any simultaneous heart and extra organ transplant, including pancreas, liver, lung, kidney, etc. Subjects who have had previous transplants may be included.
Outcomes
Primary Outcomes
RNA-seq based peripheral blood assay in heart transplant recipients
Time Frame: 3 years
Cases will be reviewed and a subset of the peripheral blood specimens will be sent to Mayo Clinic Laboratories for development of the RNA-seq signature. The number of specimens analyzed will be determined based on the incidence of rejection and the incidence of biopsies for cause needed to develop the signature.