Clinico-biological Collection to Investigate the Physiopathology of Systemic Autoimmune Diseases
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Blood sampling.
- Кому может быть актуально
- Состояния в реестре: Lupus Erythematosus, Scleroderma, Myositis, Vasculitis. Базовые параметры: 6 лет — 99 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Франция
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Constitution of a Collection of Biological Samples With the Aim of Carrying Out Clinico-biological and Pathophysiological Investigations of Systemic Autoimmune Diseases
Обзор
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
Подробное описание
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.
Вмешательства
- Биопрепарат Blood sampling
Blood will be taken in larger quantity.
Первичные конечные точки
- Constitution of a collection of biological samples and clinical-biological data from patients with autoimmune diseases [Срок оценки: through study completion, an average of 1 year]
Вторичные конечные точки (4)
- Identification and / or validation of new biomarkers for diagnostic and / or prognostic purposes [Срок оценки: through study completion, an average of 1 year]
- Identification and / or validation of new predictive biomarkers of relapse and / or response to treatment [Срок оценки: 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 [Срок оценки: through study completion, an average of 1 year]
- Identification of the determinants of immune reconstitution after cell therapy [Срок оценки: through study completion, an average of 1 year]
Критерии участия
Критерии включения
- 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.).
Критерии исключения
- Known anemia and hemoglobin <10 g / dl
- Patients under protective supervision (guardianship, curators)
- 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
- Purpan University Hospital — Toulouse
Идентификаторы
NCT: NCT05251415 · RC31/21/0505