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NCT07416201 · ClinicalTrials.gov registry record
Natural History of Dysregulation and Aging of the Immune System in People With Trisomy 21 With and Without Thymectomy
A clinical trial of Down Syndrome, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Recruiting
- Registry status
- 700
- Enrollment target
- 1
- Study location
NCT07416201: Recruiting study of Down Syndrome, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT07416201 is a study of Down Syndrome that is actively recruiting participants, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 700 participants, below the 2,459-participant average among 54 other Down Syndrome trials with a reported enrollment target (72% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07416201, a study of Down Syndrome, is actively recruiting participants, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- RECRUITING
- Registry status
- 700 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
Describe the immune correlates of clinical endpoints (infections, autoimmunity, malignancies), and their cumulative frequency over time, in individuals with T21. Describe the possible impact of previous thymectomy on the incidence of clinical manifestations of immune deficiency and immune dysregulation, and on laboratory parameters of immune function
Conditions Studied
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 700 participants |
| Start Date | 2026-03-26 |
| Est. Completion | 2040-11-01 |
What NCT07416201 shows while recruiting
NCT07416201 is an observational study that tracks outcomes without assigning an intervention. The registered 700 participants enrollment target is mid-sized for trials with a published cap, below the 2,459-participant average among 54 other Down Syndrome trials with a reported enrollment target (72% lower).
The record links to 1 condition, with Down Syndrome appearing as the primary indexed condition, and to 0 interventions.
NCT07416201 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT07416201 about?
NCT07416201 is a clinical study titled "Natural History of Dysregulation and Aging of the Immune System in People With Trisomy 21 With and Without Thymectomy". 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 sometim...
What is the current status of trial NCT07416201?
This trial is currently recruiting. The enrollment target is 700 participants. The study started on 2026-03-26. Estimated completion is 2040-11-01.
What conditions does trial NCT07416201 study?
This clinical trial studies the following conditions: Down Syndrome.
Who is sponsoring clinical trial NCT07416201?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07416201 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Down Syndrome
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07416201's enrollment target sits among peer trials
700 10th of 54 higher than 45 of 54 other Down Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Down Syndrome trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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