Constitution of a Collection of Biological Samples With the Aim of Carrying Out Clinico-biological and Physiopathological Investigations of Autoimmune, Dysimmune or Auto-inflammatory Dermatological Diseases
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- Building a collection of biological samples and clinical-biological data from patients with autoimmune, dysimmune or auto-inflammatory dermatological disease
研究概览
简要总结
The aim of this project is to start a biological and clinical collection of patients presenting autoimmune, dysimmune or auto-inflammatory dermatological diseases. 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 include around 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
- •Skin damage of documented or probable autoimmune, dysimmune or autoinflammatory origin.
- •The patients included may be adults or children, and will be:
- •Patients with autoimmune bullous dermatoses (pemphigus, pemphigoid and others),
- •Patients with systemic autoimmune diseases associated with skin damage (lupus, scleroderma, dermatomyositis for example),
- •Patients with cutaneous lupus
- •Patients with dysimmune skin diseases (psoriasis, eczema)
- •Patients with immuno-induced dermatological disorders or drug dermatitis
- •Patients receiving, or likely to receive, new, innovative therapies (new molecule on the market, checkpoint inhibitors, gene therapy, cell therapy, etc.).
- •Patients with dermatological damage whose autoimmune, dysimmune or auto-inflammatory origin is suspected
排除标准
- •Patients under protective supervision (guardianship, curators)
- •Patients under 6 years old
- •Pregnant or breastfeeding woman
研究组 & 干预措施
Patients suffering from autoimmune, dysimmune or auto-inflammatory dermatological disease
Biological samples will be collected in the normal diagnosis and follow-up process
干预措施: Blood sampling (Biological)
Patients suffering from autoimmune, dysimmune or auto-inflammatory dermatological disease
Biological samples will be collected in the normal diagnosis and follow-up process
干预措施: Remainders of samples taken as part of the treatment (Biological)
结局指标
主要结局
Building a collection of biological samples and clinical-biological data from patients with autoimmune, dysimmune or auto-inflammatory dermatological disease
时间窗: Day 0 and through study completion, an average of 1 year
Blood sampling
次要结局
- Comparison of blood cells populations determinants with flow cytometry, before and after cell therapy and in patients responder or not responder to cell therapy(Day 0 and through study completion, an average of 1 year)
- Identification of biomarkers regarding the severity (such as cytokines, survival factors) in order to help the therapeutic decisions(Day 0 and through study completion, an average of 1 year)
- Identification of new autoantibodies(Day 0 and through study completion, an average of 1 year)
- Exploration of the pathophysiological mechanisms of rare autoimmune dermatological pathologies(Day 0 and through study completion, an average of 1 year)