Clinico-biological Collection of Autoimmune, Dysimmune or Auto-inflammatory Dermatological Diseases

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Биопрепарат Blood sampling
  Blood will be taken in larger quantity
• Биопрепарат Remainders of samples taken as part of the treatment
  blood, CSF, saliva, stools, urine, other biological fluids and tissue biopsies, hair follicles

Первичные конечные точки

• Building a collection of biological samples and clinical-biological data from patients with autoimmune, dysimmune or auto-inflammatory dermatological disease [Срок оценки: Day 0 and through study completion, an average of 1 year]

Вторичные конечные точки (4)

• Identification of new autoantibodies [Срок оценки: 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 [Срок оценки: Day 0 and through study completion, an average of 1 year]
• Exploration of the pathophysiological mechanisms of rare autoimmune dermatological pathologies [Срок оценки: Day 0 and through study completion, an average of 1 year]
• Comparison of blood cells populations determinants with flow cytometry, before and after cell therapy and in patients responder or not responder to cell therapy [Срок оценки: Day 0 and through study completion, an average of 1 year]

Критерии участия

Критерии включения

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

Критерии исключения

• Patients under protective supervision (guardianship, curators)
• Patients under 6 years old
• Pregnant or breastfeeding woman

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Франция · 1 центр

• University Hospital — Toulouse

Идентификаторы

NCT: NCT06387654 · RC31/23/0361

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗