Genome Transplant Dynamics
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|ClinicalTrials.gov Identifier: NCT02423070|
Recruitment Status : Recruiting
First Posted : April 22, 2015
Last Update Posted : June 11, 2019
- Some people with advanced heart and lung disease have heart and lung transplants. But the organs are often rejected. When this happens, the organ recipients must have repeated biopsies. These are invasive and expensive. Researchers want to see if a blood test can predict rejection and take the place of biopsies. The test shows how much donor DNA is in a recipient s blood.
- To see if a new blood test can be used instead of biopsies to diagnose rejection after transplant.
- Adults 18 years and older who are on the lung or heart transplant waitlist.
- Participants will have about 4 teaspoons of blood drawn from the arm before having their transplant.
- Researchers will collect demographic data about participants. They will also collect basic medical information about their condition.
- After surgery, while still in the hospital, participants will have 2 teaspoons of blood drawn twice a week until they go home.
- At each biopsy visit after the transplant, participants will have 4 teaspoons of blood drawn for testing for up to 5 years.
|Condition or disease|
|Thoracic Organ Transplantation|
|Study Type :||Observational|
|Estimated Enrollment :||495 participants|
|Official Title:||Genome Transplant Dynamics|
|Actual Study Start Date :||June 25, 2015|
|Estimated Primary Completion Date :||November 1, 2024|
|Estimated Study Completion Date :||November 30, 2024|
- To validate the predictive accuracy and ROC characteristics of the percentage of circulating cell-free donor-derived DNA (%ccfdDNA) in a multicenter, prospective cohort study of heart-and lung-transplant patients, recruited through a consortium ... [ Time Frame: 5 years ]Our approach is a multicenter, prospective cohort study involving 5 local transplant centers, all of which have pre-transplant and post-transplant clinics. All transplant waitlist patients have regular clinic monitoring visits while they transplant. Occasionally, pre-transplantpatients with high disease burden are hospitalized untiltransplantation. After transplantation, patients arehospitalized for an average of 1-2 weeks. After discharge, patients are then followed regularly in transplant clinics and undergo scheduledbiopsies to monitor for rejection. Patients with signs of graft dysfunction undergo unscheduled biopsy and/or clinic visits. Clinic and biopsy schedules for each center are shown in Appendix III.
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): NCT02423070
|Contact: Sean T Agbor-Enoh, M.D.||(703) firstname.lastname@example.org|
|United States, District of Columbia|
|MedStar Health Institutions||Recruiting|
|Washington, District of Columbia, United States|
|United States, Maryland|
|Johns Hopkins University||Recruiting|
|Baltimore, Maryland, United States, 21205|
|University of Maryland at Baltimore/MPRC||Recruiting|
|Catonsville, Maryland, United States, 21228|
|United States, Virginia|
|INOVA Fairfax Hospital||Recruiting|
|Falls Church, Virginia, United States, 22042|
|Virginia Commonwealth University||Recruiting|
|Richmond, Virginia, United States, 23284|
|Principal Investigator:||Sean T Agbor-Enoh, M.D.||National Institutes of Health Clinical Center (CC)|