Natural History of Dysregulation and Aging of the Immune System in People With Trisomy 21 With and Without Thymectomy
Key facts
- Where
- Bethesda, United StatesSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 1 and 120 years old?
Source: NCT07416201, who can take part
Where in United States
- National Institutes of Health Clinical CenterBethesda, United StatesContact: NIH Clinical Center Office of Patient Recruitment (OPR)Taking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- National Institute of Allergy and Infectious Diseases (NIAID)
- Trial code
- NCT07416201
- Record updated
- 29 October 2026
- Original description
Background:Read full original descriptionShow less
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.
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Exclusion: 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; An individual who meets any of the following criteria will be excluded from participation in this study:.
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.