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Natural History of Trisomy 8-Associated Autoinflammatory Disease (TRIAD) and Related Disorders

Recruitingn/aAges 1 Day - 99 YearsAllNational Institute of Allergy and Infectious Dise…
NCT07683104 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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: Phy

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📋 Eligibility rules (as published)
* INCLUSION CRITERIA: To be eligible to participate in this study, an individual must meet the following criteria: 1. Stated willingness to comply with study requirements. 2. Aged \<= 99 (ability to be seen at NIH vs. remote visit may be determined by age and location). 3. Willingness to allow storage of data and specimens for future research. Additional Inclusion Criteria for Affected Participants 1. Must have one of the following: 1. Trisomy 8 mosaicism verified by genetic testing (including but not limited to karyotype, fluorescence in situ hybridization \[FISH\], whole genome sequencing \[WGS\], whole exome sequencing \[WES\], or microarray), or 2. Inflammatory mucosal ulcerative disease clinically similar to TRIAD at the discretion of the principal investigator. 2. Ability of participant or LAR to provide informed consent. Additional Inclusion Criteria for Biological Relatives 1. Be an unaffected biological relative of an affected participant. 2. Ability to provide informed consent. 3. Willingness to provide at least one biospecimen. EXCLUSION CRITERIA: Individuals with any condition or who are taking any medications that, in the opinion of the investigator, contraindicates participation in the study will be excluded. Co-enrollment guidelines: Enrollment in this protocol does not preclude individuals from enrolling or participating in any other NIH protocols, including studies of investigational agents. Participants will be asked about their participation in other studies to ensure that blood draws do not exceed NIH limits for research protocols.
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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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