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NIAID Centralized Sequencing Protocol for Immune Disorders

This study aims to understand the genetic causes of immune disorders like allergies (atopy), primary immunodeficiency, autoimmunity, and autoinflammation. Researchers use genetic testing called "sequencing" to look at your DNA and identify differences (variants) that might be linked to these conditions. The goal is to find new genetic problems causing immune disorders, identify new ways these disorders show up in people, and confirm known genetic disorders. You can join if you are already part of another NIH study or referred from a specific lung disease study. The study is ongoing and plans to include up to 20,000 participants.

Study design
This is an observational study, meaning researchers will collect information without giving any specific interventions. It plans to enroll up to 20,000 participants of all ages and genders.
What's involved
You will provide biological samples for genetic testing. You must also be enrolled in a primary study that handles your main medical and research evaluations.
Compensation
Not stated in the trial record.
Follow-up
Follow-up is measured upon analysis of genomic data, which means after your genetic information has been studied.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03206099

NIAID Centralized Sequencing Protocol

Recruiting
Not specifiedAges 1+Observational
National Institute of Allergy and Infectious Diseases (NIAID)
~20,000 participants
Updated 2026-08-27 on ClinicalTrials.gov

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Identifying novel genetic defects associated with immune disorders
Measured over Upon analysis of genomic data
+2 more outcomes measured

Conditions

Atopy
Primary Immunodeficiency
Autoimmunity
Autoinflammation

Explore related trials

AtopyAutoimmune StatusAutoinflammationInborn Error of ImmunityInherited Immunodeficiency Diseases

Where it's being run

2 sites across 2 states
District of Columbia1
Maryland1

Study leadership

  • Morgan N Similuk · PRINCIPAL_INVESTIGATOR · National Institute of Allergy and Infectious Diseases (NIAID)

Who to contact

Morgan N Similuk
[email protected]
(301) 435-6691
Email the study team

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Eligibility criteria

Inclusion

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.

What this trial measures

  • Identifying novel genetic defects associated with immune disordersUpon analysis of genomic data

    Identifying novel genetic defects associated with immune disorders

  • Identifying novel clinical phenotypes associated with established genetic defectsUpon analysis of genomic data

    Identifying novel clinical phenotypes associated with established genetic defects

  • Identifying established genetic disorders of the immune systemUpon analysis of genomic data

    Identifying established genetic disorders of the immune system, as well as known genetic disorders outside of the immune system in some cases