Genetic testing for immune disorders
NIAID Centralized Sequencing Protocol
This study is testing how genetic factors affect immune disorders by looking at samples from people already involved in other research, to help improve care and understanding of these conditions.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20000 (estimated) |
| Ages | 1 Day to 100 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 2 sites (Washington D.C., District of Columbia and 1 other locations) |
| Trial ID | NCT03206099 on ClinicalTrials.gov |
What this trial studies
This study focuses on understanding the genetic factors contributing to immune disorders through next-generation sequencing technologies. Participants, who are already involved in other NIH research protocols, will provide biological samples for genetic analysis. The research aims to enhance clinical care and improve the understanding of genetic variations related to immune diseases. By systematically collecting and analyzing genomic data, the study seeks to uncover insights into immune regulation and host defense mechanisms.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 0-99 years who are participants in other NIH protocols and are willing to undergo genetic testing.
Not a fit: Patients who are not enrolled in NIH research protocols or those unwilling to provide biological samples for testing may not benefit from this study.
Why it matters
Potential benefit: If successful, this research could lead to improved diagnosis and treatment options for patients with immune disorders.
How similar studies have performed: Other studies utilizing genetic sequencing for understanding immune disorders have shown promise, indicating that this approach is both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion criteria
* PARTICIPANT INCLUSION CRITERIA: * Must fulfill one of the following criteria: * Proband participants: must be individuals under investigation by another NIH protocol on which they are co-enrolled, or are referred from the GDMCC protocol "Defining the Genetic Etiology of Suppurative Lung Disease in Children and Adults" (NCT04702243). Probands may have a disease under investigation or be healthy volunteers * Biological relatives: biologically related to a proband participant. * Aged 0-99 years. * Participants must be willing to undergo genetic testing. * Participants must be willing to allow samples to be stored for future research. * Participants must be willing to have their de-identified genomic data shared, for example in a controlled access databases like the Database of Genotypes and Phenotypes (dbGaP). * To complete surveys and interviews: * Proficient with the English language. * Able to provide informed consent. * Adult healthy volunteers must be able to provide informed consent. PARTICIPANT EXCLUSION CRITERIA: Any condition that, in the opinion of the investigator, contraindicates participation in this study is a reason for exclusion.
Where this trial is running
Washington D.C., District of Columbia and 1 other locations
- Children's National Health System — Washington D.C., District of Columbia, United States (Recruiting)
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Morgan N Similuk — National Institute of Allergy and Infectious Diseases (NIAID)
- Study coordinator: Morgan N Similuk
- Email: morgan.similuk@nih.gov
- Phone: (301) 435-6691
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.