Participation in a Research Registry for Immune Disorders

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Brief Title

Participation in a Research Registry for Immune Disorders

Official Title

NIH Participation to USIDNET Registry

Brief Summary


      - 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.


      - To collect data on people with primary immune deficiency disorders.


      - People who have a PIDD.


        -  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

Detailed Description

      The purpose of this protocol is to provide a resource for clinical and laboratory research
      through enrollment of known immunodeficiency patients into a national registry, the US
      Immunodeficiency Network (USIDNET). The registry data will expand NIH s and the nation s
      knowledge base about immune deficiency disorders and genetic mutations that lead to these
      disorders. Additional registrants from NIH protocols will not only increase the understanding
      of the molecular basis of these disorders, but also will serve to document and track the
      incidence and progression of complications.

      Objectives and specific aims

      The purpose of this proposal is to create a mechanism for depositing NIH data into USIDNET.
      The patient Registry is designed to obtain longitudinal data on a large number of patients
      with primary immunodeficiency diseases, and genetic carriers of these defects in order to:

        -  Learn more about the phenotypic variations seen in a large number of individual patients
           with the same rare molecular diagnosis.

        -  Determine the natural history of these genetic disorders of immunity and establish
           genotype-phenotype correlations.

        -  Learn effects of various treatment protocols used in these patients over time, including
           unexpected side effects that may be unique to a particular diagnostic group.

        -  To evaluate quality of life using standard tools and correlate these with genotype and
           treatment history.

        -  To promote collaborative research amongst interested investigators by identifying a
           larger pool of potential research subjects than would be available at their own

        -  To identify patients with a specific diagnosis for potential participation in
           multi-institutional clinical trials designed for diagnosis or therapy or their specific

Study Type


Primary Outcome



Primary Immunodeficiencies

Study Arms / Comparison Groups

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


* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Estimated Enrollment


Start Date

September 30, 2013

Completion Date

May 1, 2025

Primary Completion Date

May 1, 2020

Eligibility Criteria


        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.


        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.




1 Month - N/A

Accepts Healthy Volunteers



Elizabeth K Garabedian, R.N., (301) 435-2443, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations



Organization ID


Secondary IDs


Responsible Party


Study Sponsor

National Human Genome Research Institute (NHGRI)


 National Institute of Allergy and Infectious Diseases (NIAID)

Study Sponsor

Elizabeth K Garabedian, R.N., Principal Investigator, National Human Genome Research Institute (NHGRI)

Verification Date

September 21, 2022