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Набор скоро начнётся NCT05424627

Myeloid Derived Suppressor Cells in Systemic Lupus Erythematosus

Наблюдательное Systemic Lupus Erythematosus

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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Systemic Lupus Erythematosus. Базовые параметры: 18 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 →
Официальное название

Involvement of Myeloid Derived Suppressor Cells in Systemic Lupus Erythematosus

Обзор

Systemic Lupus Erythematosus (SLE) is a chronic invalidating chronic condition, with potential articular, cutaneous, renal, and neurologic involvement. Its pathophysiology is complex, and involves genetic, environmental and hormonal factors, leading to tolerance rupture. Among regulatory cells, Myeloid Derived Suppressor Cells (MDSCs) have been described as being increased during SLE, furthermore during flares. MDSCs are defined phenotypically as being HLA-DR-CD3-CD19-CD33+CD11b+, and either CD14+ (Monocytic MDSCs), CD15+ (Granulocytic MDSCs), or CD14-CD15- (Early-stage MDSCs). However, data regarding their immunosuppressive properties are conflicting, some studies identifying regulatory properties, while other have demonstrated a pro-inflammatory involvement through the induction of Th17 lymphocytes. The objectives of this study is to assess the involvement of MDSC in SLE through accurate phenotypical and functional assessment, as well as characterizing their immunometabolic profile, and to identify innovative therapeutic strategies.

Подробное описание

Systemic Lupus Erythematosus (SLE) is a chronic invalidating chronic condition, with potential articular, cutaneous, renal, and neurologic involvement. Its pathophysiology is complex, and involves genetic, environmental and hormonal factors, leading to tolerance rupture. Among regulatory cells, Myeloid Derived Suppressor Cells (MDSCs) have been described as being increased during SLE, furthermore during flares. MDSCs are defined phenotypically as being HLA-DR-CD3-CD19-CD33+CD11b+, and either CD14+ (Monocytic MDSCs), CD15+ (Granulocytic MDSCs), or CD14-CD15- (Early-stage MDSCs). However, data regarding their immunosuppressive properties are conflicting, some studies identifying regulatory properties, while other have demonstrated a pro-inflammatory involvement through the induction of Th17 lymphocytes.

To gain insight into the involvement of MDSC in SLE, both deep phenotypical characterization of MDSC and functional assessment will be performed, as well as immunometabolic characterization. This data will be correlated to the clinical presentation and activity of SLE.

Первичные конечные точки

  • MDSC percentage among total PBMC [Срок оценки: Baseline]
  • MDSC percentage among total PBMC [Срок оценки: 3 months]
  • MDSC percentage among total PBMC [Срок оценки: 6 months]
  • MDSC percentage among total PBMC [Срок оценки: Between 9 and 24 months if patient experience relapse during follow-up]
Вторичные конечные точки (12)
  • Serum cytokine levels [Срок оценки: Baseline]
  • Serum cytokine levels [Срок оценки: 3 months]
  • Serum cytokine levels [Срок оценки: 6 months]
  • Serum cytokine levels [Срок оценки: Between 9 and 24 months if patient experience relapse during follow-up]
  • MDSC inflammasome activation [Срок оценки: Baseline]
  • MDSC inflammasome activation [Срок оценки: 3 months]
  • MDSC inflammasome activation [Срок оценки: 6 months]
  • MDSC inflammasome activation [Срок оценки: Between 9 and 24 months if patient experience relapse during follow-up]
  • Immunometabolic profile [Срок оценки: Baseline]
  • Immunometabolic profile [Срок оценки: 3 months]
  • Immunometabolic profile [Срок оценки: 6 months]
  • Immunometabolic profile [Срок оценки: Between 9 and 24 months if patient experience relapse during follow-up]

Критерии участия

Критерии включения

  • Active systemic lupus erythematosus (SLEDAI > or = 1)
  • Written informed consent

Критерии исключения

  • Chronic or acute infection
  • Other active auto-immune condition
  • Active cancer
  • Age below 18

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
  • Thomas Moulinet — Vandœuvre-lès-Nancy

Идентификаторы

NCT: NCT05424627 · 2022-A00601-42

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗