Genome Transplant Dynamics
National Heart, Lung, and Blood Institute (NHLBI)
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 both), age 14 and older People who are within three months of their transplant People who can understand and agree to take part in the study Participants will be asked to provide blood and other samples, and some of these will be used in lab research to explore new ideas about how and why transplant rejection happens. This research could lead to better ways to monitor and treat patients after a heart or lung transplant - and help improve long-term survival and quality of life.
Description
Acute rejection (AR) occurs within the first 6 months after transplantation in 20 percent of heart- transplant patients and in 50 percent of lung-transplant patients. Given the often silent clinical presentation of AR, these patients require monitoring with repeated invasive and costly endomyocardial (EMB) or transbronchial biopsies (TBBx). Since organ transplantation is essentially genomic transplantation, our prior studies leveraged the use of distinctive graft and recipient genotype single-nuclear polymorphisms (SNPs) to barcode donor DNA circulating in recipient serum. We have shown that l…
Eligibility
- Age range
- 14–80 years
- Sex
- All
- Healthy volunteers
- No
* 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…
Locations (6)
- MedStar Washington Hospital CenterWashington D.C., District of Columbia
- Johns Hopkins UniversityBaltimore, Maryland
- University of MarylandBaltimore, Maryland
- National Institutes of Health Clinical CenterBethesda, Maryland
- INOVA Fairfax MedicalFalls Church, Virginia
- Virginia Commonwealth UniversityRichmond, Virginia