RecruitingNCT03206099

NIAID Centralized Sequencing Protocol


Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Enrollment

20,000 participants

Start Date

Jul 31, 2017

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 1 DayMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This study performs comprehensive genetic sequencing on participants to help identify the genetic cause of rare or unexplained diseases. It is a centralized sequencing program that supports other NIH research protocols. Both patients under investigation for an illness and their biological relatives — who may carry the same genetic variants — can participate. You may be eligible if: - You are between 0 and 99 years old - You are already enrolled in another NIH research protocol, or are referred from a related genetic lung disease study - You are a biological relative of someone already enrolled - You are willing to undergo genetic testing and have your samples stored for future research - You consent to having your de-identified genetic data shared in controlled research databases You may NOT be eligible if: - You have any condition that, in the investigator's opinion, makes participation unsafe or inappropriate Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(2)

Children's National Health System

Washington D.C., District of Columbia, United States

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

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NCT03206099


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