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Natural History of Dysregulation and Aging of the Immune System in People With Trisomy 21 With and Without Thymectomy

National Institute of Allergy and Infectious Diseases (NIAID) · NCT07416201

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 1–120 · All sexes
Healthy volunteers
Accepted
Study type
Observational
Target enrollment
700
US sites recruiting
1
Study start
June 23, 2026
Record last updated
October 19, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

Background

Down syndrome is a genetic disorder that can cause heart defects and other problems in the body. People with Down syndrome are more likely to have infections, autoimmunity, and blood diseases. Some may need surgery to treat congenital heart problems. During this surgery, doctors sometimes remove part of the thymus. The thymus is an organ that plays a role in immune function. People who have had part of their thymus removed may get sick more often than others do.

Objective

This natural history study will gather data about how removing part of the thymus affects the health of people with Down syndrome.

Eligibility

People aged 1 year and older with Down syndrome. The study will include both people who have, and those who have not had, surgery to remove part of their thymus. Healthy relatives are also needed.

Design

Participants with Down syndrome will have clinic visits at least once a year for 15 years.

At each visit they will have a physical exam. They will give blood and stool samples. They will have tests of their heart and lung function.

Participants aged 18 years or older may have at least 1 imaging scan: They will lie on a table that slides into a donut-shaped machine. The machine uses X-rays to take pictures of the inside of the body.

Participants who have tissue samples collected from their bodies (biopsies) taken during the study may have extra tissue taken for research.

Healthy relatives will also have visits once a year for 15 years. They will only have a physical exam and provide blood and stool samples.

Conditions: Down Syndrome

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria
  • INCLUSION CRITERIA:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

  • Aged >=1 year.
  • Willingness to allow storage of specimens and data for future research.
  • Additional Inclusion Criteria for Affected Participants
  • Documented T21 based on chromosomal karyotype test.
  • Ability of participant or LAR to provide informed consent.
  • Additional Inclusion Criteria for Unaffected Relatives
  • Ability of participant to provide informed consent or, for individuals \<18 years of age, to provide informed assent as applicable.
  • 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:

  • 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.

Recruiting US locations

  • National Institutes of Health Clinical Center

    Bethesda, MD 20892

    Site contact: NIH Clinical Center Office of Patient Recruitment (OPR) · 800-411-1222 · ccopr@nih.gov

Study contacts (from the official record)

  • Luigi D Notarangelo, M.D. · (301) 761-7550 · luigi.notarangelo2@nih.gov
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Natural History of Dysregulation and Aging of the Immune System in… (NCT07416201) | Bored Studies