Constitution of a Collection of Biological Samples With the Aim of Carrying Out Clinico-biological and Pathophysiological Investigations of Systemic Autoimmune Diseases
Overview
- Phase
- N/A
- Intervention
- Blood sampling
- Conditions
- Lupus Erythematosus
- Sponsor
- University Hospital, Toulouse
- Enrollment
- 3000
- Locations
- 1
- Primary Endpoint
- Constitution of a collection of biological samples and clinical-biological data from patients with autoimmune diseases
- Status
- Recruiting
- Last Updated
- last month
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
patients suffering from autoimmune disease
Biological samples will be collected in the normal diagnosis and follow-up process. Only blood will be taken in larger quantity.
Intervention: Blood sampling
Outcomes
Primary Outcomes
Constitution of a collection of biological samples and clinical-biological data from patients with autoimmune diseases
Time Frame: 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 Outcomes
- Identification and / or validation of new biomarkers for diagnostic and / or prognostic purposes(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(through study completion, an average of 1 year)
- Identification and / or validation of new predictive biomarkers of relapse and / or response to treatment(through study completion, an average of 1 year)
- Identification of the determinants of immune reconstitution after cell therapy(through study completion, an average of 1 year)