Thymus removal and immune aging in people with Down syndrome

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a longitudinal observational cohort study enrolling people with trisomy 21 (Down syndrome), including individuals who have had partial thymectomy and those who have not, plus unaffected household relatives as controls. Participants have a baseline visit and yearly follow-up visits (at least annually for up to 15 years) with physical exams and collection of biospecimens such as blood and stool, and clinical data from routine care may also be used. The study aims to define immune signatures linked to infections, autoimmunity, lung disease progression, and malignancy, and to analyze how immunomodulatory treatments and prior thymectomy influence these outcomes. All visits occur at the NIH Clinical Center in Bethesda, Maryland, and extra visits can be scheduled as clinically indicated.

Why it matters

Who can join: the full rules

* 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.

Where it's running

• National Institutes of Health Clinical Center
  Bethesda, Maryland, United States Recruiting

Study contacts

• Principal investigator: Luigi D Notarangelo, M.D. — National Institute of Allergy and Infectious Diseases (NIAID)
• Study coordinator: Luigi D Notarangelo, M.D.
• Email: luigi.notarangelo2@nih.gov
• Phone: (301) 761-7550

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.