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ISOHYPE: The Distribution of Immunoglobulin Isotype in Polyclonal Hypergammaglobulinemia in Systemic and Autoimmune Diseases

Sponsor
Centre Hospitalier Universitaire, Amiens (Other)
Overall Status
Recruiting
CT.gov ID
NCT06054373
Collaborator
Binding site (Other)
150
Enrollment
1
Location
1.2
Anticipated Duration (Months)
126.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Polyclonal hypergammaglobulinaemia is characterized by increased levels of immunoglobulins and is a common feature observed in various diseases such as autoimmune diseases, chronic infectious diseases or lymphoid hemopathy. Some autoimmune diseases such as systemic lupus erythematosus, rheumatoid arthritis or Sjögren's syndrome are frequently associated with polyclonal hypergammaglobulinaemia. Recent data have suggested that the distribution of immunoglobulin isotypes in polyclonal hypergammaglobulinaemia may be disease-specific. However, isotype repartition in polyclonal hypergammaglobulinaemia remains poorly understood.

The investigators will investigate the distribution of immunoglobulin isotype in patients with autoimmune disease and polyclonal hypergammaglobulinaemia. Moreover, the investigators will evaluate the isotype repartition as predictor of lymphoma or monoclonal gammopathy among patients with autoimmune diseases.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    150 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Retrospective
    Official Title:
    The Distribution of Immunoglobulin Isotype in Polyclonal Hypergammaglobulinemia in Systemic and Autoimmune Diseases
    Actual Study Start Date :
    Jul 27, 2023
    Actual Primary Completion Date :
    Aug 27, 2023
    Anticipated Study Completion Date :
    Sep 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. distribution of immunoglobulin isotypes [one day]

      distribution of immunoglobulin isotypes in polyclonal hypergammaglobulinaemia associated with autoimmune and systemic diseases (systemic lupus erythematosus, rheumatoid arthritis, Gougerot-Sjögren syndrome, sarcoidosis)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • All adult patients > 18 years old

    • patients with one of the following diseases: systemic lupus erythematosus, rheumatoid arthritis, Sjögren's syndrome, autoimmune hepatitis, sarcoidosis or lymphoma.

    Exclusion Criteria:

    • Age < 18 years;

    • chronic viral hepatitis;

    • HIV infection, syphilis,

    • tuberculosis

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHU Amiens Amiens France 80054

    Sponsors and Collaborators

    • Centre Hospitalier Universitaire, Amiens
    • Binding site

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Centre Hospitalier Universitaire, Amiens
    ClinicalTrials.gov Identifier:
    NCT06054373
    Other Study ID Numbers:
    • PI2023_843_0116
    First Posted:
    Sep 26, 2023
    Last Update Posted:
    Oct 2, 2023
    Last Verified:
    Sep 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Centre Hospitalier Universitaire, Amiens
    Polyclonal Hypergammaglobulinemia
    Autoimmune Diseases
    immunoglobulin isotypes
    Additional relevant MeSH terms:
    Hypergammaglobulinemia
    Autoimmune Diseases

    Study Results

    No Results Posted as of Oct 2, 2023