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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Constitution of a Collection of Biological Samples With the Aim of Carrying Out Clinico-biological and Pathophysiological Investigations of Systemic Autoimmune Diseases

Conditions
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Lupus Erythematosus, Scleroderma, Myositis, Vasculitis, Inflammatory Bowel Diseases

Intervention / Treatment
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* Biological: Blood sampling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients suffering from autoimmune disease<br>Biological samples will be collected in the normal diagnosis and follow-up process. Only blood will be taken in larger quantity. | Biological: Blood sampling<br>* Blood will be taken in larger quantity.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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systemic autoimmune diseases, scleroderma, lupus, myositis, vasculitis, Inflammatory Bowel Diseases, new therapies