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

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ClinicalTrials.gov Identifier: NCT06054373
Recruitment Status : Recruiting
First Posted : September 26, 2023
Last Update Posted : October 2, 2023
Sponsor:
Collaborator:
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Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Polyclonal Hypergammaglobulinemia Autoimmune Diseases

Study Design
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Study Type : Observational
Estimated 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 : July 27, 2023
Actual Primary Completion Date : August 27, 2023
Estimated Study Completion Date : September 2023

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Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. distribution of immunoglobulin isotypes [ Time Frame: 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
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with diagnosis of various autoimmune diseases and polyclonal hypergammaglobulinaemia. Medical records from 2004 to 2018 were reviewed to identify eligible patients.
Criteria

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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06054373


Contacts
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Contact: Valéry Salle, MD 03 22 66 82 30 salle.valery@chu-amiens.fr

Locations
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France
CHU Amiens Recruiting
Amiens, France, 80054
Contact: Valéry SALLE, MD    +33 3 22 66 82 30    salle.valery@chu-amiens.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
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More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT06054373    
Other Study ID Numbers: PI2023_843_0116
First Posted: September 26, 2023    Key Record Dates
Last Update Posted: October 2, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Hypergammaglobulinemia
Autoimmune Diseases
Immune System Diseases
 Blood Protein Disorders
Hematologic Diseases
Immunoproliferative Disorders