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NCT07683104 · ClinicalTrials.gov registry record
Natural History of Trisomy 8-Associated Autoinflammatory Disease (TRIAD) and Related Disorders
A clinical trial, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Recruiting
- Registry status
- 750
- Enrollment target
NCT07683104: Recruiting study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT07683104 is a clinical trial that is actively recruiting participants, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 750 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07683104 is actively recruiting participants, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- RECRUITING
- Registry status
- 750 participants
- Enrollment target
Study Summary
Background: Trisomy 8 mosaicism is a genetic disorder that can increase inflammation in the body. Symptoms include fevers; sores or ulcers in the mouth, digestive tract, or genital area; skin rashes; problems in organs or tissues; and changes in bone marrow cells. Researchers want to conduct a natural history study to learn more about these symptoms and what causes them. Objective: To gather data and samples from people with and without the trisomy 8 mosaicism. Eligibility: People of any age with the trisomy 8 gene mosaicism. Their healthy relatives are also needed. Design: Affected participants will have visits every 1 to 2 years for 30 years at NIH. Each visit will take 1 to 5 days and may be in-person or remote. With remote visits, participants may have a video call with the study team and samples may be sent to researchers by mail. Participants may have these procedures: Physical exam, with blood tests. Tests of brain function and motor skills. Sensory tests. Researchers will see how participants respond to sensations such as pinpricks, heat, cold, and pressure. Magnetic resonance imaging (MRI) scan of the brain and/or spine. X-ray of the spine. Ultrasound test of heart function (echocardiogram). Tissues samples (biopsies) collected from the skin, inside of the mouth, and bone marrow. Swabs to collect cells from the mouth, skin, and vagina. Collection of blood, stool, urine, saliva, hair, and fingernail samples. X-rays, MRI, and heart tests will be done only once. Other procedures may be repeated at each visit. All tests and procedures are voluntary. Healthy relatives who enroll will have a baseline visit and then follow-up visits as needed. They will have a physical exam. The inside of their mouth may be swabbed. Samples of blood, stool, urine, and saliva may be taken.
Primary Outcome
Characterize the clinical spectrum and natural history of trisomy 8 mosaicism and related disorders.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 750 participants |
| Start Date | 2026-07-15 |
| Est. Completion | 2056-06-01 |
What NCT07683104 shows while recruiting
NCT07683104 is an observational study that tracks outcomes without assigning an intervention. The registered 750 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT07683104 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07683104 about?
NCT07683104 is a clinical study titled "Natural History of Trisomy 8-Associated Autoinflammatory Disease (TRIAD) and Related Disorders". Background: Trisomy 8 mosaicism is a genetic disorder that can increase inflammation in the body. Symptoms include fevers; sores or ulcers in the mouth, digestive tract, or genital area; skin rashes; problems in organs or tissues; and changes in bone marrow cells. Researchers want to conduct a natu...
What is the current status of trial NCT07683104?
This trial is currently recruiting. The enrollment target is 750 participants. The study started on 2026-07-15. Estimated completion is 2056-06-01.
Who is sponsoring clinical trial NCT07683104?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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