Constitution of a Collection of Biological Samples With the Aim of Carrying Out Clinico-biological and Pathophysiological Investigations of Systemic Autoimmune Diseases
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- Constitution of a collection of biological samples and clinical-biological data from patients with autoimmune diseases
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Years 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.).
排除标准
- •Known anemia and hemoglobin <10 g / dl
- •Patients under protective supervision (guardianship, curators)
- •Pregnant or breastfeeding woman
研究组 & 干预措施
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.
干预措施: Blood sampling (Biological)
结局指标
主要结局
Constitution of a collection of biological samples and clinical-biological data from patients with autoimmune diseases
时间窗: through study completion, an average of 1 year
Prospective collection of all available biological samples and clinical data collected during the normal clinical care
次要结局
- 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)