Genome Transplant Dynamics
Study Description: Heart and lung transplants can save lives, but long-term success is often limited by organ rejection that is hard to detect early. This study is testing a new, non-invasive blood test that looks for small pieces of DNA from the donor organ in the patient s blood. We believe higher levels of this dono
| Condition(s) | Thoracic Organ Transplantation |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Summary | Study Description: Heart and lung transplants can save lives, but long-term success is often limited by organ rejection that is hard to detect early. This study is testing a new, non-invasive blood test that looks for small pieces of DNA from the donor organ in the patient s blood. We believe higher levels of this donor DNA may signal early rejection before damage becomes permanent. Hypothesis: We believe that measuring donor-derived DNA in the blood can help detect early signs of rejection and improve outcomes for transplant patients. The study also collects genetic and biological samples to explore why some people are more at risk of complications after transplant. This may help guide future research and treatments. Who Can Join the Study: People receiving a heart or lung transplant (or |
| Who can participate | * INCLUSION CRITERIA: * Lung and heart transplant candidates. Dual organ transplants such as those that include lung or heart PLUS any other organ are also considered for enrollment. * Subjects who have undergone lung or heart transplants and are within 3 months of transplantation. * 14 years and older * Able to understand and be willing to sign the informed consent form. Subjects undergoing a double transplant will sign a single consent. * Retransplant candidates will be considered as a new transplants. These subjects will be approached for enrollment and if they consent to participate, they will be assigned a different SSPIN. EXCLUSION CRITERIA: -Pregnancy |
| Ages | 14 Years to 80 Years |
| Sex | All |
| Lead sponsor | National Heart, Lung, and Blood Institute (NHLBI) |
| Locations | Washington D.C., District of Columbia, United States; Baltimore, Maryland, United States; Baltimore, Maryland, United States; Bethesda, Maryland, United States; Falls Church, Virginia, United States; Richmond, Virginia, United States |
| Start date | 2015-06-25 |
| NCT ID | NCT02423070 |
| Official listing | https://clinicaltrials.gov/study/NCT02423070 |