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NIAID Centralized Sequencing Protocol

National Institute of Allergy and Infectious Diseases (NIAID) · with National Institute of Mental Health (NIMH) · NCT03206099

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 0 mo–100 · All sexes
Healthy volunteers
Accepted
Study type
Observational
Target enrollment
20000
US sites recruiting
2
Study start
July 31, 2017
Record last updated
October 26, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Conditions: Atopy; Primary Immunodeficiency; Autoimmunity; Autoinflammation

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria
  • 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) or "Use of Tiered Genetic Sequencing and Specialty Referral for Identifying and Managing Rare Genetic Causes of Chronic Suppurative Respiratory Disease" (External study #: 26-1761). 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.

EXCLUSION CRITERIA

Any condition that, in the opinion of the investigator, contraindicates participation in this study is a reason for exclusion.

Recruiting US locations

  • Children's National Health System

    Washington D.C., DC 20010

    Site contact: Michael Keller, MD · 202-476-5843 · mkeller@childrensnational.org

  • National Institutes of Health Clinical Center

    Bethesda, MD 20892

    Site contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) · 800-411-1222 · ccopr@nih.gov

Study contacts (from the official record)

  • Morgan N Similuk · (301) 435-6691 · morgan.similuk@nih.gov
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