Participation in a Research Registry for Immune Disorders

Overview

  • Study type

    Observational
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 12-005979
    NCT ID: NCT01953016
    Sponsor Protocol Number: 12-005979

About this study

The purpose of this study is to build a National Registry of individuals with one of the group of primary immune deficiency diseases. A "Registry" is a list of basic information about people who have a certain disease or condition in common. These immune deficiency diseases are thought to be rare and include: Severe combined immunodeficiency (SCID), leukocyte adhesion deficiency (LAD), X-linked Agammaglobulinemia (XLA), common variable immune deficiency (CVID), DiGeorge syndrome (DGS), Hyper IgM syndrome (HIGM), Wiskott Aldrich syndrome (WAS) and chronic granulomatous disease (CGD). We would like to contribute data on a number of subjects with these relatively rare diseases to this National Registry Data Base. The information will be age, sex, race or ethnic group, immunologic lab tests that were used to diagnose the condition, what complications may have occurred since the condition started, lung disease, blood changes, etc. and the results of various treatments used. The goal is to discover basic outcome data, ethnic, racial characteristics, kind of complications and useful treatments. You will not be contacted by anyone unless you authorize it. If a new study about you (or your child’s) immune defect comes up, your doctor will be notified, who can then share this with you to find out if you are interested in participating or not. Alternatively you may elect to be contacted directly by the Registry to determine your interest in participation.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

INCLUSION CRITERIA

Individuals of all ages, gender, and races with an immunodeficiency disorder from NIH studies, and their relatives who share the genetic mutation for the disorder will be accepted for registration.

No healthy volunteers will be enrolled.

EXCLUSION CRITERIA

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.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Avni Joshi, M.D.

Contact us for the latest status

Contact information:

Kay Bachman R.N., C.C.R.C.

(507)284-5689

bachman.kay@mayo.edu

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CLS-20315012

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