The TOGETHER Project - Heart
TOGETHER
The TOGETHER Project - Transplant Organ Genomics to Help Prevent Rejection in Heart Transplant Recipients
1 other identifier
observational
101
1 country
3
Brief Summary
The researchers are trying to develop a way to measure the risk of transplant rejection with a blood test.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 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
December 7, 2017
CompletedFirst Submitted
Initial submission to the registry
February 5, 2019
CompletedFirst Posted
Study publicly available on registry
February 6, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 22, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 22, 2020
CompletedJune 14, 2022
June 1, 2022
2.8 years
February 5, 2019
June 10, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
RNA-seq based peripheral blood assay in heart transplant recipients
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.
3 years
Study Arms (1)
Heart Transplant Recipients
Heart Transplant Recipients meeting the criteria for enrollment and consented will be followed post transplant for 1 year after enrollment into the study. Blood samples will be obtained at their 1, 3, 6, 12 months and any for cause heart biopsy's obtained. There will be no active intervention for recipients that are enrolled. Results from the samples will not be obtained in real time.
Eligibility Criteria
Heart Transplant recipients
You may qualify if:
- 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
You may not qualify if:
- 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 studyc3. Any simultaneous heart and extra organ transplant, including pancreas, liver, lung, kidney, etc. Subjects who have had previous transplants may be included.
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, 559055, United States
Related Links
Biospecimen
15 ml peripheral Blood samples will be processed for DNA extraction and plasma for RNA seq isolation peripheral blood assay will be obtained at 1, 3, 6, 12 months and for cause.
Study Officials
- PRINCIPAL INVESTIGATOR
Naveen Pereira, M.D.
Mayo Clinic
- PRINCIPAL INVESTIGATOR
Mark D Stegall, M.D.
Mayo Clinic
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 5, 2019
First Posted
February 6, 2019
Study Start
December 7, 2017
Primary Completion
September 22, 2020
Study Completion
September 22, 2020
Last Updated
June 14, 2022
Record last verified: 2022-06