Clinico-biological Collection to Investigate the Physiopathology of Systemic Autoimmune Diseases

Recruiting

• Conditions: Scleroderma; Lupus Erythematosus; Inflammatory Bowel Diseases; Myositis; Vasculitis
• Interventions: Biological: Blood sampling

• Registration Number: NCT05251415
• Lead Sponsor: University Hospital, Toulouse

Brief Summary

The aim of this project is to start a biological and clinical collection of patients presenting systemic autoimmune disease. This collection will provide appropriate biological samples to identify new biomarkers and to be accessible to the medical, scientific and industrial communities for the identification of new therapeutic strategies

Detailed Description

Autoimmune diseases group together less than a hundred different clinical entities which are for the most part rare pathologies but which, in combination, concern 5-8% of the adult population with a strong female predominance (FAI²R: the disease chain rare autoimmune and auto-inflammatory drugs, fai2r.org). The common denominator of all these diseases is based on the breakdown of self-tolerance which is the origin of self-reactivity and whose physiopathological mechanisms are still not fully understood, which generates numerous cross-sectional or fundamental studies. In addition to this complexity, there are significant inter-individual variabilities which lead to the definition of subgroups of patients on the basis of the clinical-biological profile and / or the response to treatments. Consequently and in view of the need to establish the diagnosis early and then to propose the best treatment in the perspective of an individualized medicine, the clinical, biological and genetic characteristics of these subgroups of patients must be explored in order to improve diagnostic and therapeutic capacities.

Study Timeline

• Study First Submitted: 2022-01-24
• Study First Submitted QC: 2022-02-11
• Study First Posted: 2022-02-22
• Study Start: 2022-04-04
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-28
• Last Update Posted: 2024-03-29
• Primary Completion: 2027-04-04
• Study Completion: 2032-04-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3000

Inclusion Criteria

• Patients with rare systemic autoimmune diseases (lupus, scleroderma, myositis for example),
• Patients with atypical presentations of documented or probable systemic autoimmune diseases,
• Patients receiving, or likely to receive new, innovative therapies (new molecule on the market, gene therapy, cell therapy, etc.).

Exclusion Criteria

• Known anemia and hemoglobin <10 g / dl
• Patients under protective supervision (guardianship, curators)
• Pregnant or breastfeeding woman

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients suffering from autoimmune disease	Blood sampling	Biological samples will be collected in the normal diagnosis and follow-up process. Only blood will be taken in larger quantity.

Primary Outcome Measures

Name	Time	Method
Constitution of a collection of biological samples and clinical-biological data from patients with autoimmune diseases	through study completion, an average of 1 year	Prospective collection of all available biological samples and clinical data collected during the normal clinical care

Secondary Outcome Measures

Name	Time	Method
Identification and / or validation of new biomarkers for diagnostic and / or prognostic purposes	through study completion, an average of 1 year	Use of immune cells and / or biological liquids obtained from patients for cohort studies with new methods of screening (microarray, flow cytometry)
Identification of specificities in these patients in order to improve the diagnosis, treatment decisions and / or the pathophysiological understanding of these diseases	through study completion, an average of 1 year	Use of immune cells and / or biological samples for transcriptomic and / or proteomic studies, or in order to be used in experimental animal models
Identification and / or validation of new predictive biomarkers of relapse and / or response to treatment	through study completion, an average of 1 year	Use of immune cells and / or biological liquids obtained from patients for cohort studies with new methods of screening (microarray, flow cytometry)
Identification of the determinants of immune reconstitution after cell therapy	through study completion, an average of 1 year	Exploring blood cell populations before and after cell therapy with flow cytometry

Trial Locations

Locations (1)

Purpan University Hospital; 🇫🇷 Toulouse, France