Study of STIM1 Membrane Expression

NCT04978948 | Recruiting

• 1 other identifier: STIMEX - 29BRC21.0025
• Study Type: observational
• Target: 670
• Locations: 1 country
• Sites: 4

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.

Conditions

Autoimmune Diseases

Keywords

autoimmune diseases

Outcome Measures

Primary Outcomes (1)

• level of STIM1-PM

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

  Day 0

Secondary Outcomes (1)

• correlation between STIM1 expression and Clinical Score

  Day 0

Study Arms (18)

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

Lichen plan buccal auto-immun (LPB)

Blood samples will be collected

lichen plan buccal allo-immun liée à une GvHD (" Graft versus Host Disease ")

Blood samples will be collected

Lupus érythémateux systémique

Blood samples will be collected

Sclérodermie

Blood samples will be collected

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient over 18 years old. Diagnosis of one of the autoimmune diseases of interest according to the commonly accepted classification criteria for each disease, regardless of the level of disease activity.

You may qualify if:

• Diagnosis of one of the autoimmune diseases

You may not qualify if:

• Treatment with rituximab in the previous 12 months

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (4)

CHRU de Brest - Service de rhumatologie

Brest, Brest, 29200, France

RECRUITING

Centre Hospitalier des Pays de Morlaix

Morlaix, Brittany Region, 29672, France

RECRUITING

Centre Hospitalier de Quimper

Quimper, Brittany Region, 29000, France

RECRUITING

CHU de Martinique

Fort-de-France, Martinique, 97261, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

2 venous blood samples/patient or 9 venous blood samples/patient for patients suffering from disease for which an increase in the membrane expression of STIM1 has been identified.

MeSH Terms

Conditions

Autoimmune Diseases

Condition Hierarchy (Ancestors)

Immune System Diseases

Central Study Contacts

Divi Cornec

CONTACT

02 98 22 33 33; divi.cornec@chu-brest.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2021
• First Posted: July 27, 2021
• Study Start: May 11, 2021
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: February 6, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available beginning two years and ending five years following the publication
• Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.

Locations

FR (4)