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Observational Study of Donor DNA for Thoracic Organ Transplant Rejection

This study is looking at a new blood test to help detect organ rejection early in people who have received heart or lung transplants. The test measures small pieces of DNA from the donor organ (called cell-free donor derived DNA or cfDNA) in your blood. Researchers believe that higher levels of this donor DNA could be an early sign of rejection, even before it causes serious damage. The study aims to see how well this blood test predicts rejection compared to traditional biopsies. You might be able to join if you are between 14 and 80 years old and have recently had a heart or lung transplant, or are a candidate for one. The study is also collecting genetic and biological samples to understand why some people are more likely to have complications after transplant. The current status of this study is unclear.

Study design
This is an observational study involving nearly 1000 participants who have received heart or lung transplants. It is designed to validate the accuracy of a blood test for organ rejection.
What's involved
The primary measurement for this study will be taken at the time of a biopsy-proven rejection. The trial record does not specify other visits, procedures, or tests.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at the time of biopsy-proven rejection, but the overall duration of follow-up is not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT02423070

Genome Transplant Dynamics

Recruiting
Not specifiedAges 14–80Observational
National Heart, Lung, and Blood Institute (NHLBI)
~991 participants
Updated 2026-08-27 on ClinicalTrials.gov

At a glance

Recruiting sites
3 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To validate the predictive accuracy and ROC characteristics of circulating cell- free donor derived DNA (cfDNA) in multicenter, prospective cohort study of heart and lung transplant patients, recruited through a consortium of 5 transplant center...
Measured over At the time of biopsy-proven rejection

Conditions

Thoracic Organ Transplantation

Explore related trials

Heart TransplantationLung Transplantation

Where it's being run

6 sites across 3 states
Maryland3
Virginia2
District of Columbia1

Study leadership

  • Sean T Agbor-Enoh, M.D. · PRINCIPAL_INVESTIGATOR · National Heart, Lung, and Blood Institute (NHLBI)

Who to contact

Sean T Agbor-Enoh, M.D.
[email protected]
(703) 677-4630
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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Pregnancy

What this trial measures

  • To validate the predictive accuracy and ROC characteristics of circulating cell- free donor derived DNA (cfDNA) in multicenter, prospective cohort study of heart and lung transplant patients, recruited through a consortium of 5 transplant center...At the time of biopsy-proven rejection

    Fold change in cfDNA at the time of biopsy-proven rejection