Pathogenicity of B and CD4 T Cell Subsets in Multiple Sclerosis
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 sample, cerebro-spinal fluid.
- Кому может быть актуально
- Состояния в реестре: Multiple Sclerosis, Clinically Isolated Syndrome. Базовые параметры: от 18 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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Обзор
The study aims at identifying the type of B and CD4 T cell subsets with pathogenic properties in the different clinical forms of multiple sclerosis. This research might open new therapeutic approaches for the treatment of multiple sclerosis particularly progressive MS.
Подробное описание
Multiple sclerosis (MS) is a chronic autoimmune disease damaging the central nervous system (CNS). MS is categorized into several distinct forms according to clinical symptoms and medical examinations. Relapsing-remitting multiple sclerosis (RRMS) is characterized by attacks of worsening neurologic function, followed by partial or complete recovery periods. Patients can also present a gradual but steady progression of the disease (progressive forms). While several treatment options are currently available, no treatment completely stops the disease progression. Therefore, a deeper understanding regarding the mechanism of the disease development is essential to generate more efficient treatment strategies. CD4 T cells are known to be significantly involved in the formation of the CNS lesions characteristic of MS.The investigators hypothesize that different types of B and CD4 T cells play major roles in different forms of the disease. They will determine the phenotype and functions of the cells from the immune system particularly B and CD4 T cells present in the blood and cerebro-spinal fluid (CSF) of patients diagnosed with multiple sclerosis or presenting a clinically isolated syndrome.
The study will recruit 150 patients followed in Bordeaux University Hospital and diagnosed for clinically isolated syndrome (CIS) or multiple sclerosis (MS). Blood and CSF will be collected during a scheduled visit to study the properties of cells from the immune system in particular CD4 T cells in multiple sclerosis. Clinical and biological disease activity, treatment and outcomes will be studied in correlation with the properties of blood and CSF lymphocytes. No extra visit will be needed and the blood and CSF samples will be collected at the same times as those collected for clinical purposes.
Вмешательства
- Биопрепарат blood sample
28 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation - Биопрепарат cerebro-spinal fluid
1 ml of cerebro-spinal fluid
Первичные конечные точки
- Functional and phenotypical characterization of the blood and CSF lymphocytes in MS and CIS patients. [Срок оценки: At inclusion (day 0)]
Вторичные конечные точки (11)
- Quantification of disease activity scores [Срок оценки: At inclusion (day 0)]
- Quantification of disease activity scores [Срок оценки: At inclusion (day 0)]
- Number of lesions [Срок оценки: At inclusion (day 0)]
- Size of lesions [Срок оценки: At inclusion (day 0)]
- Localisation of lesions [Срок оценки: At inclusion (day 0)]
- Types of lesions [Срок оценки: At inclusion (day 0)]
- duration of the disease [Срок оценки: At inclusion (day 0)]
- age at onset and progression [Срок оценки: At inclusion (day 0)]
- number of relapses [Срок оценки: At inclusion (day 0)]
- date of relapses [Срок оценки: At inclusion (day 0)]
- Treatment [Срок оценки: At inclusion (day 0)]
Критерии участия
Критерии включения
- male or female subjects ;
- Age ≥ 18 years;
- subjects with MS defined by 2010 revised McDonald criteria or presenting a clinical isolated syndrome;
- patients for which a blood draw and / or lumbar puncture to collect CSF is performed for diagnostic or therapeutic purpose;
- affiliated to an health insurance system;
- and who agree to participate in the study.
Критерии исключения
- Pregnant or breastfeeding women,
- patient concerned by articles L 1121-5 to L 1121-8 (persons deprived of their liberty by a judicial or administrative decision, minors, persons of legal age who are the object of a legal protection measure or unable to express their consent)
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Не применимо
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Другое
Центры проведения
Франция · 1 центр
- CHU de Bordeaux - service de neurologie — Bordeaux
Идентификаторы
NCT: NCT04798651 · CHUBX 2020/71