NIAID Clinical Center Genomics Opportunity Protocol

NCT02417766 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 139

Last updated 2023-03-16

No results posted yet for this study

Summary

Background:

\- There are many types of immune disorders. These range from rare immune deficiencies to allergies to autoimmune disease like rheumatoid arthritis. Genes are the instructions our body uses to work and develop. A new technology called whole exome sequencing may help find the cause of these disorders. Whole exome sequencing is a way to look at many genes at once for errors. Researchers hope to find new gene changes that lead to immune disorders. Additionally, researchers are interested in finding the best way to manage unexpected but important findings by whole exome sequencing.

Objectives:

\- To better understand genetic causes of immune system disorders. Also, to better understand people s thoughts and feelings about immune system disorders and new genomic testing.

Eligibility:

\- People ages 0 100 with an immune disorder or a relative with an immune disorder. People must be at least 2 to be evaluated at the NIH clinical center. People must be at least 12 to do the survey/interview portion of the study.

Design:

* Participants will have their genes sequenced. They may be asked for a new sample of blood.
* If participants cannot come for a study visit, they can have a blood sample collected by their local lab or doctor and sent by mail.
* Researchers may or may not find the cause of the participant s immune disorder. Participants will learn that information. Some participants may be asked to return to NIH to get results and have more tests.
* Researchers may share information with other studies. The data will be anonymous.
* For the survey part of the study, participants will answer questions about their or their relative s immune disorder. They will also answer about their thoughts and feelings about genomic testing.
* Some participants will be asked for a brief interview to ask more about the survey topics. There may be more follow-up after several months.

Conditions

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

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

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-29
Primary Completion
2019-01-22
Completion
2019-01-22

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02417766 on ClinicalTrials.gov