Non-invasive blood test for early detection of organ rejection in heart and lung transplants
Genome Transplant Dynamics
This study is testing a new blood test to see if it can help heart and lung transplant patients catch early signs of organ rejection before it causes serious problems.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 991 (estimated) |
| Ages | 14 Years to 80 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 6 sites (Washington D.C., District of Columbia and 5 other locations) |
| Trial ID | NCT02423070 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients receiving heart or lung transplants and aims to validate a new non-invasive blood test that detects donor-derived cell-free DNA (cfDNA) in the recipient's blood. By measuring levels of this cfDNA, the study seeks to identify early signs of acute rejection, which can occur silently and lead to serious complications. Participants will provide blood samples, and the study will also collect genetic and biological data to understand why some patients experience more complications post-transplant. The ultimate goal is to improve monitoring and outcomes for transplant patients by detecting rejection earlier than traditional biopsy methods allow.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 14 and older who are within three months of receiving a heart or lung transplant.
Not a fit: Patients who are pregnant or those who do not meet the inclusion criteria for heart or lung transplantation will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to earlier detection of organ rejection, potentially improving the long-term success of heart and lung transplants.
How similar studies have performed: Previous studies have shown promising results using cfDNA for detecting acute rejection, indicating that this approach has potential but requires further validation.
Eligibility criteria
Show full inclusion / exclusion criteria
* 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
Where this trial is running
Washington D.C., District of Columbia and 5 other locations
- MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States (Completed)
- Johns Hopkins University — Baltimore, Maryland, United States (Recruiting)
- University of Maryland — Baltimore, Maryland, United States (Terminated)
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)
- INOVA Fairfax Medical — Falls Church, Virginia, United States (Recruiting)
- Virginia Commonwealth University — Richmond, Virginia, United States (Active_not_recruiting)
Study contacts
- Principal investigator: Sean T Agbor-Enoh, M.D. — National Heart, Lung, and Blood Institute (NHLBI)
- Study coordinator: Sean T Agbor-Enoh, M.D.
- Email: agborenohst@mail.nih.gov
- Phone: (703) 677-4630
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.