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15-Year study to uncover how thymus removal affects immune health in down syndrome

NCT ID NCT07416201

Knowledge-focused Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jul 17, 2026 · Updated 3 times

Summary

This natural history study will follow 700 people with Down syndrome and their healthy relatives for up to 15 years. Researchers want to learn how removing part of the thymus during heart surgery affects the immune system over time. Participants will have yearly check-ups, blood and stool tests, and heart and lung function tests. The goal is to better understand infections, autoimmune problems, and blood diseases in this population.

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 700 people

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

Started

Jun 2026

Expected to finish

Nov 2040

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

Participants will be selected in an equitable manner from the available pool of potentially eligible individuals, without regard to factors such as sex, race, ethnicity, socioeconomic status, etc. To facilitate recruitment, the study will be registered in clinicaltrials.gov and will be shared with T21 advocacy groups.

Ages

1 year to 120 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: In order to be eligible to participate in this study, an individual must meet all of the following criteria: 1\. Aged \>=1 year. 2\. Willingness to allow storage of specimens and data for future research. * Additional Inclusion Criteria for Affected Participants 1. Documented T21 based on chromosomal karyotype test. 2. Ability of participant or LAR to provide informed consent. * Additional Inclusion Criteria for Unaffected Relatives 1. Ability of participant to provide informed consent or, for individuals \<18 years of age, to provide informed assent as applicable. 2. Reside in the same household as the corresponding affected participant. EXCLUSION CRITERIA: An individual who meets any of the following criteria will be excluded from participation in this study: 1\. Any condition that, in the judgment of the investigator, may put the participant at undue risk or make them unsuitable for participation in the study.

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Conditions

The condition(s) this trial relates to.

Down syndrome inborn error of immunity

As listed by the trial registrant

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

Down syndrome

How to take part

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

  1. The places running it

    1 site. 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

  • National Institutes of Health Clinical Center

    RECRUITING

    Bethesda, Maryland, 20892, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.