NIAID Centralized Sequencing Protocol
- Atopy
- Primary Immunodeficiency
- Autoimmunity
- Autoinflammation
At a glance
- Phase
- Phase not stated
- Study type
- Observational
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Enrolment target
- 20,000
- Started
- 31 July 2017
- Main results due
- 31 December 2029
- Study sites
- 2
- Registry updated
- 28 September 2026
Can you take part?
- Ages 1 day to 100 years.
- Open to any sex.
- Healthy volunteers can take part.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility 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.
What this study is about
In the sponsor’s own words, from the registry.
Background:
Genetic testing called "sequencing" helps researchers look at DNA. Genes are made of DNA and are the instructions for our bodies to function. We all have thousands of genes. DNA variants are differences in genes between two people. We all have lots of variants. Most are harmless and some cause differences like blue or brown eyes. A few variants can cause health problems.
Objective:
To understand the genetics of immune disorders various health conditions, as well as outcomes of clinical genomics and genetic counseling services performed under this protocol.
Eligibility:
Participants in other NIH human subjects research protocols - either at the NIH Clinical Center (CC) or at Children s National Health System (CNHS) - (aged 0-99 years), and, in select cases, their biological relatives
Design:
Researchers will study participant s DNA extracted from blood, saliva, or another tissue sample, including previously collected samples we may have stored at the NIH. Researchers will look at participant s DNA in great detail. We are looking for differences in the DNA sequence or structure between participants and other people.
Participants will receive results that:
* Are important to their health * Have been confirmed in a clinical lab * Suggest that they could be at risk for serious disease that may affect your current or future medical management.
Some genetic information we return to participants may be of uncertain importance.
If genetic test results are unrelated to the participant s NIH evaluations, then we will not typically report:
* Normal variants * Information about progressive, fatal conditions that have no effective treatment * Carrier status (conditions you don t have but could pass on)
The samples and data will be saved for future research.
Personal data will be kept as private as possible.
If future studies need new information, participants may be contacted....
Study sites(2)
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
Showing 2 of 2 sites. 2 of the 2 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT03206099. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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