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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 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.

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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.

Conditions Studied

Study Locations (1)

Maryland

  • National Institutes of Health Clinical Center - Bethesda

Trial Details

FieldValue
Enrollment Target 700 participants
Start Date 2026-03-26
Est. Completion 2040-11-01

What the Registry Record Tells You About NCT07416201

The ClinicalTrials.gov registry entry for NCT07416201 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 700 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,459-participant average among 54 other Down Syndrome trials with a reported enrollment target (72% lower). The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Down Syndrome appearing as the primary indexed condition, and to 0 interventions.

NCT07416201 reports 1 study location spanning 1 distinct geographic area - top geographies include 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.

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