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Simple blood test could spot transplant rejection before damage is done

NCT ID NCT02423070

Knowledge-focused Sponsor: National Heart, Lung, and Blood Institute (NHLBI) Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Sep 21, 2026 · Updated 13 times

Summary

This study is testing a non-invasive blood test that looks for donor DNA in the blood of heart and lung transplant patients. Higher levels of this DNA may signal early rejection before permanent damage occurs. About 991 participants aged 14 and older will provide blood samples over time to see if the test can predict rejection and improve long-term outcomes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
blood test for donor DNA
What this could lead to
If successful, this blood test could help doctors catch organ rejection early, potentially improving survival and quality of life for transplant patients.
What could go wrong
This is an observational study, not a treatment trial. The test may not prove accurate enough for routine use, and results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 991 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2015

Expected to finish

Nov 2034

An estimate. End dates often move.

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

14 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

* 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

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Thoracic organ transplantation

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    4 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Dignity Health St. Joseph's Hospital and Medical Center Norton Thoracic Institut

    RECRUITING

    Phoenix, Arizona, 85013, United States

  • INOVA Fairfax Medical

    RECRUITING

    Falls Church, Virginia, 22042, United States

  • Johns Hopkins University

    RECRUITING

    Baltimore, Maryland, 21218, United States

  • MedStar Washington Hospital Center

    COMPLETED

    Washington D.C., District of Columbia, 20010, United States

  • National Institutes of Health Clinical Center

    RECRUITING

    Bethesda, Maryland, 20892, United States

  • University of Maryland

    TERMINATED

    Baltimore, Maryland, 21228, United States

  • Virginia Commonwealth University

    ACTIVE_NOT_RECRUITING

    Richmond, Virginia, 23284, United States