NIAID Centralized Sequencing Protocol
Trial Summary
What is the purpose of this trial?
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 relativesDesign: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.
Research Team
Morgan N Similuk
Principal Investigator
National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria
Inclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Genetic Testing and Analysis
Participants provide biological specimens for genetic testing, including DNA extraction and sequencing to identify genetic variants.
Genetic Counseling and Reporting
Participants receive results that are important to their health, confirmed in a clinical lab, and may affect medical management.
Follow-up
Participants are monitored for safety and effectiveness of genetic counseling and testing outcomes.
Treatment Details
Interventions
- Centralized Sequencing Protocol
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Who Is Running the Clinical Trial?
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor
National Institute of Mental Health (NIMH)
Collaborator