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Can a donor Organ's gene signature foretell rejection?

NCT ID NCT00531921

Knowledge-focused Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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
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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 25, 2026 · Last updated Sep 25, 2026

Summary

Researchers are studying whether the activity of inflammation-related genes in donated organs is linked to early organ dysfunction and rejection after transplant. The study enrolls people who have received a heart, lung, liver, or kidney transplant and whose donor tissue samples were collected. By comparing gene expression in donor and recipient tissue with transplant outcomes, the team aims to understand whether these biological signals can help predict which organs will run into trouble.

What this could mean

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

What this could lead to
If the link holds, doctors could one day check donor organs for these gene signals and tailor anti-rejection treatment before problems start.
What could go wrong
This is an observational study, so it can show a correlation but not prove cause and effect. The findings may not apply to all transplant patients or change care on their own.

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

313 people

The number who actually took part.

Start date

Sep 2007

Finished

Aug 2011

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

Transplant patients evaluated for the association between proinflammatory mRNA expression from donor samples and subsequent development of early organ dysfunction

Ages

Up to 70 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 for all participants: * Received single lung, heart, kidney, or liver transplant * Specimens of donor tissues have been collected * Parent or guardian willing to provide informed consent, if applicable Inclusion Criteria for Kidney or Liver Transplant Participants: * 70 years old or younger Inclusion Criteria for Heart or Lung Transplant Participants: * Between 16 and 70 years old Exclusion Criteria for All Participants: * Previous solid organ transplant * Need for combined organ transplant * HIV or hepatitis C virus infection * Recipient of an organ from a hepatitis C virus-infected donor * Clinical evidence of systemic bacterial infection in the recipient at the time of transplantation * Living donor transplant recipient of either a kidney, liver, or lung

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Conditions

The condition(s) this trial relates to.

heart disorder kidney disorder kidney failure liver disorder liver failure lung disorder Rejection, Psychology

As listed by the trial registrant

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

Heart transplantation Kidney transplantation Liver transplantation Lung transplantation

Contacts and locations

Locations

  • Columbia University (lung and liver)

    New York, New York, 10032, United States

  • Cornell University Medical College (kidney)

    Ithaca, New York, 14850, United States

  • Northwestern Memorial Hospital (kidney and liver)

    Chicago, Illinois, 60611, United States

  • University of Pennsylvania (heart, kidney, liver, lung)

    Philadelphia, Pennsylvania, 19104, United States

  • University of Wisconsin (heart and lung)

    Madison, Wisconsin, 53706, United States

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