NIAID Centralized Sequencing Protocol

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Study ID
NCT03206099
Status
Recruiting
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Conditions

  • Atopy
  • Autoimmunity
  • Autoinflammation
  • Primary Immunodeficiency

Eligibility Criteria

Sex
ALL
Age
1 Day - 100 Years
Healthy Volunteers
Accepted

Study Details

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.

Key Dates

Start date
Jul 31, 2017
Status verified
Apr 2026
Primary completion
Dec 31, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
20,000 participants (estimated)

Arms

  • Arm: Biological relatives
    Biological relatives of probands, who may or may not also be co-enrolled on the proband's referring protocol.
  • Arm: Healthy volunteers
    Select internal controls
  • Arm: Probands
    Participants with a disease under investigation by another NIAID protocol on which they are enrolled, either at the NIH or CNHS.

Primary Outcome Measure

Identifying novel genetic defects associated with immune disorders [ Time Frame: Upon analysis of genomic data ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Children's National Health SystemWashington D.C.District of Columbia20010
Michael Keller, MD
[email protected]
202-476-5843
National Institutes of Health Clinical CenterBethesdaMaryland20892
For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)
[email protected]
800-411-1222

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By research site
Children's National Health System· Washington D.C., DCNational Institutes of Health Clinical Center· Bethesda, MD

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