What this study is
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.
Study details
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
- Conditions
- Thoracic Organ Transplantation
- Enrolling
- 991 people
- Starts
- 2015-06-25
- Est. completion
- 2034-11-30
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 14 Years – 80 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.
You can't join if
- Pregnancy
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (7)
4 openDignity Health St. Joseph's Hospital and Medical Center Norton Thoracic Institut
Phoenix, Arizona, United States
- Sofya Tokman, M.D. · Contact602-406-4000sofya.tokman@commonspirit.org
RecruitingJohns Hopkins University
Baltimore, Maryland, United States
- Steven Hsu · Contact410-955-3468steven.hsu@jhmi.edu
- Pali Shah · Contact(410) 955-3468pdedhiy2@jhmi.edu
RecruitingNational Institutes of Health Clinical Center
Bethesda, Maryland, United States
- For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) · Contact800-411-1222 ext. TTY dial 711ccopr@nih.gov
RecruitingINOVA Fairfax Medical
Falls Church, Virginia, United States
- Palak Shah, M.D. · Contact703-776-2213palak.shah@inova.org
- Steven Nathan, M.D. · Contact(703) 776-2213steven.nathan@inova.org
RecruitingMedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
CompletedUniversity of Maryland
Baltimore, Maryland, United States
TerminatedVirginia Commonwealth University
Richmond, Virginia, United States
Active, not recruiting
Study team
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Study ID 999915115
Principal investigator
Sean T Agbor-Enoh, M.D.
National Heart, Lung, and Blood Institute (NHLBI)
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.