Participation in a Research Registry for Immune Disorders

NCT01953016 | Completed

• 2 other identifiers: 13019913-HG-0199
• Study Type: observational
• Target: 716
• Locations: 1 country
• Sites: 1

Brief Summary

Background: \- People with primary immune deficiency diseases (PIDD) have weak immune systems. This makes it hard for their bodies to fight infection. The Immune Deficiency Foundation has a network to collect data about people with PIDD. It is called the United States Immunodeficiency Network. It will help doctors and scientists better understand these disorders. The goal is to get medical data for everyone with these disorders in the U.S. and Canada. Data will be stored in a registry. Researchers can use it to study if these disorders are increasing. They can also learn how the disorders are diagnosed and treated. Objectives: \- To collect data on people with primary immune deficiency disorders. Eligibility: \- People who have a PIDD. Design:

• Data can be added with no record of personal identity.
• Data can be added with identity kept separate. This data will be linked to the registry by a code number.
• Data for the registry includes:
• Family history
• Disease treatment
• Disease characteristics
• Medical history
• Laboratory data

Conditions

Primary Immunodeficiencies; APECED; CGD; Wiskott-Aldrich Syndrome; SCID

Keywords

Job Syndrome/HIES; GATA2; Primary Immunodeficiency; SCID; DOCK8; Natural History

Outcome Measures

Primary Outcomes (1)

• Prevalence

  The Registry will provide a minimum estimate of the prevalence of each disorder in the US, a comprehensive clinical picture of each disorder, and a resource for clinical and laboratory research.

  Ongoing

Study Arms (1)

immunodeficiency

Individuals of all ages, gender, and races with an immunodeficiency disorder from NIH studies, will be accepted for registration.

Eligibility Criteria

• Age: 1 Month+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals of all ages, gender, and races with an immunodeficiency disorder from NIH studies, will be accepted for registration.@@@

You may qualify if:

• Individuals of all ages, gender, and races with an immunodeficiency disorder from NIH studies will be accepted for registration. No healthy volunteers will be enrolled.

You may not qualify if:

• Individuals with immunodeficiency associated with HIV infection, chemotherapy or other immunosuppressive therapies will not be accepted for registration unless there is clear evidence that these individuals also have a genetically determined immunodeficiency disease as well. Adult individuals who do not give informed consent will also be excluded.

Sponsors & Collaborators

• National Human Genome Research Institute (NHGRI): lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Publications (1)

• Ruffner MA; USIDNET Body Weight Group; Sullivan KE. Complications Associated with Underweight Primary Immunodeficiency Patients: Prevalence and Associations Within the USIDNET Registry. J Clin Immunol. 2018 Apr;38(3):283-293. doi: 10.1007/s10875-018-0492-0. Epub 2018 Apr 4.

  PMID: 29619656 DERIVED

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Polyendocrinopathies, Autoimmune; Wiskott-Aldrich Syndrome; Primary Immunodeficiency Diseases

Condition Hierarchy (Ancestors)

Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphopenia; Leukopenia; Cytopenia; Hemorrhagic Disorders; Leukocyte Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, X-Linked; Immunologic Deficiency Syndromes

Study Officials

• Elizabeth K Garabedian, R.N.

  National Human Genome Research Institute (NHGRI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2013
• First Posted: September 30, 2013
• Study Start: September 30, 2013
• Primary Completion: May 1, 2020
• Study Completion: July 19, 2023
• Last Updated: July 20, 2023

Record last verified: 2023-07

Locations

US (1)