NCT04473742已完成不适用
Effects of Silica and Asbestos Fibres on the Efferocytosis Capacities of Macrophages
Rennes University Hospital2 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2021年3月31日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Efferocytosis Index (EI) calculation (%) defined as the number of efferocyte MDM / total number of MDM
研究概览
简要总结
Evaluation of the efferocytosis capacities of blood Monocyte Derived Macrophages (MDM) from patients with a history of asbestosis or silica exposure and comparison of these capacities with those of MDM from healthy donors.
详细描述
Patients with a proven history or current exposure will have 4 EDTA tubes drawn, approximately 24mL of fresh whole blood for efferocytosis assessment and :
- 2 x 6mL serum tubes for the assessment of Antinuclear Antibody (ANA) positivity, serum high-mobility group box 1 (HMGB1) and osteopontin for patients exposed to asbestos
- 1 x 6mL serum tube for serum HMGB1 and osteopontin for patients exposed to silica
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient older than 18 Yo
- •Addressed to the department of occupational disease
- •With a history of asbestosis or silica exposure evaluated by a dedicated questionnaire and a throughout examination of the history of occupations, according to standard procedures for the follow-up of at risk workers.
- •Persons who received an oral and written information on the protocol and signed the informed consent form
排除标准
- •Pregnant or breastfeeding women
- •Subject legally protected (under judicial protection, guardianship), persons deprived of liberty
结局指标
主要结局
Efferocytosis Index (EI) calculation (%) defined as the number of efferocyte MDM / total number of MDM
时间窗: Through study completion, an average of 2 years
次要结局
- EI calculation in patients positive for ANA vs patients negative for ANA(Through study completion, an average of 2 years)
- Serum concentration of HMGB1 and Osteopontin (SPP1) by ELISA(Through study completion, an average of 2 years)
研究者
研究点 (2)
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