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STIMEX: Study of STIM1 Membrane Expression

Sponsor
University Hospital, Brest (Other)
Overall Status
Recruiting
CT.gov ID
NCT04978948
Collaborator
(none)
430
Enrollment
1
Location
23.7
Anticipated Duration (Months)
18.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this study is to determine the expression of STIM1 in the plasma membrane of lymphocytes from patients suffering from different autoimmune diseases in order to identify new pathologies of interest presenting an over-expression of STIM1PM.

This would allow to initiate, following this study, research and development programs on the use of anti-STIM1 antibodies in these identified autoimmune diseases of interest.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    430 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Study of STIM1 Membrane Expression During Autoimmune Diseases
    Actual Study Start Date :
    May 11, 2021
    Anticipated Primary Completion Date :
    May 1, 2023
    Anticipated Study Completion Date :
    May 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Myasthénie

    Blood samples will be collected
    Myopathie inflammatoire (Myosite)

    Blood samples will be collected
    Neuropathie autoimmune

    Blood samples will be collected
    Néphropathies autoimmunes

    Blood samples will be collected
    Hépatite auto-immune

    Blood samples will be collected
    Pancréatite auto-immune

    Blood samples will be collected
    Purpura Thrombopénique Immunologique

    Blood samples will be collected
    Dermatose bulleuse

    Blood samples will be collected
    Thyroïdite autoimmune

    Blood samples will be collected
    Sclérose en plaque

    Blood samples will be collected
    Sclérose latérale amyotrophique

    Blood samples will be collected
    Polyarthrite Rhumatoïde

    Blood samples will be collected
    Spondylarthrite axiale

    Blood samples will be collected
    controls

    Patients without autoimune desease* Blood samples will be collected

    Outcome Measures

    Primary Outcome Measures

    1. level of STIM1-PM [Day 0]

      Membrane expression level of STIM1-PM on the surface of immune cells, measured by flow cytometry

    Secondary Outcome Measures

    1. correlation between STIM1 expression and Clinical Score [Day 0]

      Study of correlation between STIM1 expression on different cells and clinical scores of different autoimmune diseases or treatments received

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Diagnosis of one of the autoimmune diseases
    Exclusion Criteria:
    • Treatment with rituximab in the previous 12 months

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHRU de Brest - Service de rhumatologie Brest France 29200

    Sponsors and Collaborators

    • University Hospital, Brest

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Brest
    ClinicalTrials.gov Identifier:
    NCT04978948
    Other Study ID Numbers:
    • STIMEX - 29BRC21.0025
    First Posted:
    Jul 27, 2021
    Last Update Posted:
    Jul 27, 2021
    Last Verified:
    Jul 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Brest
    autoimmune diseases
    Additional relevant MeSH terms:
    Autoimmune Diseases

    Study Results

    No Results Posted as of Jul 27, 2021