Bio Metrology of Nonfibrous Mineral Particles in Bronchoalveolar Lavage Fluids
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Number of non fibrous mineral particles in LBA (Bronchoalveolar lavage) (nombre of particles by ml)
研究概览
简要总结
The main purpose of this study is to update the pulmonary retention values of non-fibrous mineral particles in the general population.
This study will provide reference values for the interpretation and diagnosis of the cause of certain respiratory diseases potentially related to mineral particles.
详细描述
Some non-fibrous mineral particles are responsible for respiratory or systemic diseases, most often of occupational origin. Their use concerns multiple professional sectors.
The bio metrology of these particles, namely their quantification in a biological medium requires reference values. These are essential for clinicians to interpret pulmonary retention in patients who may have been exposed professionally or environmentally to non-fibrous mineral particles.
A comparative study conducted in 2015 by lafp showed an increase in the particulate load of nonfibrous mineral particles, including titanium, in lung parenchyma samples over time.
Bronchoalveolar lavage fluid is typically considered to be representative of the lung for the analysis of nonfibrous mineral particles. The thresholds currently used for the bio metrology of nonfibrous mineral particles in bronchoalveolar lavage fluid samples are based on reference values established more than 20 years ago. It is therefore appropriate to update these reference values by establishing a new control population from the analysis of bronchoalveolar lavage fluid from subjects not exposed to the non-fibrous mineral particles in a professional or environmental manner.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects not exposed to Non-fibrous Mineral Particle in a professional and / or environmental way.
- •Smokers and non-smokers (or weaners who have been weaned for at least 5 years).
- •Acceptance to participate in the protocol.
- •Affiliated to a social security scheme.
排除标准
- •Suspicion of fibrosing pulmonary pathologies.
- •Suspicion of pulmonary sarcoidosis ≥ stage 2, pneumoconiosis.
- •Subjects with cystic fibrosis.
- •Subjects chronic obstructive pulmonary disease (COPD) stage ≥
- •Presence of serious comorbidities that are life-threatening in the short term.
- •Refusal to participate in the study.
结局指标
主要结局
Number of non fibrous mineral particles in LBA (Bronchoalveolar lavage) (nombre of particles by ml)
时间窗: 1 month
Quantitative analysis of Non Fibrous Mineral Particles on samples obtained from subjects selected free from any significant occupational or environmental exposure to Non-fibrous Mineral Particle.
次要结局
- Name of non fibrous mineral particles in LBA (Bronchoalveolar lavage) (nombre of particules by ml)(1 month)
- seize of non fibrous mineral particles in LBA (Bronchoalveolar lavage)(1 month)