NCT02417766

NIAID Clinical Center Genomics Opportunity Protocol

Completed Last updated 16 March 2023

What this trial tests

trial in Immune Disorders in 139 participants. Completed in 22 January 2019.

Timeline

29 June 2015

Primary endpoint
22 January 2019

22 January 2019

Quick facts

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Status	Completed
Study type	OBSERVATIONAL
Enrollment	139
Start date	29 June 2015
Primary completion	22 January 2019
Estimated completion	22 January 2019
Sites	1 location across United States

Conditions studied

• Immune Disorders — all drugs for Immune Disorders →

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Who can join

Eligibility, any sex, with Immune Disorders. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Immunologic Profiling of CSF in Subarachnoid Neurocysticercosis Reveals Specific Interleukin-10-Producing Cell Populations During Treatment.
   Tang NL, Schaughency P, Gazzinelli-Guimaraes P, Lack J, et al · · 2024 · cited 2× · PMID 39475624 · DOI 10.1212/nxi.0000000000200320