Immune health in people with Down syndrome after partial thymus removal
Follows how immune health differs in Down syndrome with or without thymus surgery.
Key facts
- Who runs it
- National Institute of Allergy and Infectious Diseases (NIAID)
- Where
- Bethesda, United StatesSee the site
- Trial code
- Registry title
- Natural History of Dysregulation and Aging of the Immune System in People With Trisomy 21 With and Without Thymectomy
- Status
- Recruiting
- People taking part
- 700 people, planned
- Started
- 23 Jun 2026
- Expected to end
- 1 Nov 2040
- Type of study
- Observational, 2 groups
- Record updated
- 29 October 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people with Down syndrome (trisomy 21), with or without past removal of part of the thymus. Healthy relatives who live in the same household can also join.
- Age
- 1 year and older (up to 120 years).
- Sex
- All sexes.
- Disease stage
- Down syndrome. People who have had part of their thymus removed during heart surgery, and people who have not, can both join.
- Earlier treatment
- Past surgery to remove part of the thymus is allowed but not required.
- Biomarker or test result
- For participants with Down syndrome: T21 documented by a chromosome test (karyotype).
Main reasons for not taking part
- Any condition that the study doctor thinks puts the person at undue risk or makes taking part unwise.
- Not willing to allow storage of samples and data for future research.
- Relatives who do not live in the same household as the participant with Down syndrome.
The registry criteria, word for word
Show all 7 criteriaShow less
Who cannot take part
- 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:
Other 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
Check if you might fit
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?
Where in United States
- National Institutes of Health Clinical CenterBethesda, United StatesContact: NIH Clinical Center Office of Patient Recruitment (OPR)Taking people
About the trial
What the trial wants to find out
Background:
Read full original descriptionShow less
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.
...
The 2 groups in the trial
- Trisomy 21 Participants
Participants aged \>=1 year old who have T21
- Unaffected Relative Participants
Participants aged \>=1 year old who are related to a participant with T21
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 doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Natural History of Dysregulation and Aging of the Immune System in People With Trisomy 21 With and Without Thymectomy
- Plain-language title
- Immune health in people with Down syndrome after partial thymus removalGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 14 November 2026.
- Fit questions
- Built from NCT07416201, who can take part
- Record updated
- 29 October 2026