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Идёт набор NCT05698173

Systemic Lupus Erythematosus and Accelerated Aging

Без фазы С лечением 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
В протоколе указаны: blood sample, blood sample.
Кому может быть актуально
Состояния в реестре: Systemic Lupus Erythematosus. Базовые параметры: 18 лет — 60 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 →

Обзор

The study aims at evaluating the phenomena of immune system aging in patients with Systemic lupus erythematosus.

Подробное описание

Systemic lupus erythematosus (SLE) is a chronic systemic autoimmune disease characterized by a breakdown of tolerance against nuclear antigens. Thanks to improvements during the last decades in diagnosis, therapeutics and medical care, the lifespan of SLE patients has remarkably increased. However, standardized mortality ratio are still high in this population, with an increased mortality and morbidity associated with cardiovascular events and infectious events. Interestingly, these conditions are more commonly found during old age in the general population, raising the question of the presence of an acceleration of the aging process in SLE patients.

It has been demonstrated that the aging of the immune system, i.e. immunosenescence, is a key player in the development of many age-related diseases. The acceleration of immunosenescence, as it is observed during chronic viral infections for example, could favor the premature occurrence of clinical manifestations of accelerated aging. The exact contribution of such phenomenon in the context of SLE has, so far, never been explored.

Here, the investigators propose to perform a comprehensive study of the phenomena of immune system aging in patients with SLE in comparison to age-matched healthy controls.

The study will recruit 50 SLE patients followed in Bordeaux University Hospital. Among classical disease activity information, blood samples will be collected at study visit to extensively evaluate immune system aging. Fundamental research will be realized on patients' samples. Patients will be included within their usual follow-up. No extra visit will be needed, and blood samples will be drawn at the same time as those drawn for clinical purposes.

Вмешательства

  • Биопрепарат blood sample
    48 ml whole blood for Peripheral blood mononuclear cell (PBMC) and serum isolation
  • Биопрепарат blood sample
    blood for Peripheral blood mononuclear cell (PBMC) and serum isolation

Первичные конечные точки

  • Absolute numbers of naïve T lymphocytes [Срок оценки: At baseline (Day 0)]
Вторичные конечные точки (12)
  • Absolute numbers of terminally differentiated T lymphocytes [Срок оценки: At baseline (Day 0)]
  • Percentages of terminally differentiated T lymphocytes among total lymphocytes [Срок оценки: At baseline (Day 0)]
  • Percentages of senescent lymphocytes among total lymphocytes [Срок оценки: At baseline (Day 0)]
  • Telomere length in sorted CD4+ and CD8+ T lymphocytes subsets (naïve and memory) [Срок оценки: At baseline (Day 0)]
  • Frequency and phenotype of ELA-specific CD8+ T-cells after 10 days of in vitro priming [Срок оценки: At baseline (Day 0)]
  • Number of naïve T lymphocytes newly produced by thymus evaluated by T-cell receptor excision circles (TRECs) measurement [Срок оценки: At baseline (Day 0)]
  • Concentrations of senescence-associated secretory phenotype (SASP) markers in patients sera [Срок оценки: At baseline (Day 0)]
  • Presence or absence of anti-type I interferons autoantibodies in patients sera [Срок оценки: At baseline (Day 0)]
  • Measurement of disease activity according to Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) [Срок оценки: At baseline (Day 0)]
  • Measurement of disease activity according to British Lupus Assessment Group Index 2004 (BILAG-2004) [Срок оценки: At baseline (Day 0)]
  • Quantification of organ damage according to SLICC/ACR Damage Index [Срок оценки: At baseline (Day 0)]
  • Levels of anti-double stranded DNA in patients sera [Срок оценки: At baseline (Day 0)]

Критерии участия

Критерии включения

  • male or female;
  • age between 18 and 60 years;
  • Lupus patient : diagnosis of systemic lupus erythematosus according to ACR or SLICC criteria;
  • being affiliated to health insurance;
  • willing to participate and to sign informed consent.

Критерии исключения

  • pregnant or breastfeeding women;
  • 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: Да

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Другое

Центры проведения

Франция · 1 центр
  • CHU de Bordeaux - Médecine Interne et Immunologie Clinique — Bordeaux

Идентификаторы

NCT: NCT05698173 · CHUBX 2022/53

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗