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

Recruitingn/aAges 1 Year - 120 YearsAllNational Institute of Allergy and Infectious Dise…
NCT07416201 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 visit

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📋 Eligibility rules (as published)
* 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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What it tests

  • Not listed
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Where

1 site
National Institutes of Health Clinical Center
Bethesda, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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