MINASARC01: Comparison of Characteristics of Bronchoalveolar Lavage Dusting and of Specific Questionnary Data in Healthy Volunteers and Patients Suffering From Sarcoidosis: Pilot Study, Prospective, Multicenter, Multidisciplinary With Blind Analysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 主要终点
- Significant difference between dusting rate of bronchoalveolar lavage in healthy volunteers and patients suffering from sarcoidosis (analysis by Optical Microscopy, Transmission Electron Microscopy and MicroAnalysis).
研究概览
简要总结
Comparison of dusting rate of bronchoalveolar lavage in healthy volunteers and patients suffering from sarcoidosis.
Blind analysis of bronchoalveolar lavage with Optical Microscopy, Transmission Electron Microscopy and MicroAnalysis.
For patients, comparison of bronchoalveolar lavage, pathological examination of biopsies (Optical Microscopy, Transmission Electron Microscopy and MicroAnalysis) and specific Professional and environmental questionnary.
Healthy volunteers matched with patients regarding to age (every 10 years), sex and tobacco consumption (non-smoking, smoking less than 5 pack-year, smoking between 5 and 10 pack-year, smoking more than 10 pack-year)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Absence of respiratory and cardiac illness (healthy volunteers)
- •Normal spirometry and chest x-ray (healthy volunteers)
- •Absence of viral infection (B and C hepatitis, HIV) (healthy volunteers)
- •Confirmation of sarcoidosis (endoscopic exam with bronchoalveolar lavage) (patients suffering from sarcoidosis)
排除标准
- •Pregnant women
- •Lack of bronchoalveolar lavage (volume less than 20 ml)
研究组 & 干预措施
Healthy volunteers
Bronchoalveolar lavage in healthy volunteers
干预措施: Bronchoalveolar lavage (Other)
Patients suffering from sarcoidosis
Bronchoalveolar lavage in patients suffering from sarcoidosis
干预措施: Bronchoalveolar lavage (Other)
结局指标
主要结局
Significant difference between dusting rate of bronchoalveolar lavage in healthy volunteers and patients suffering from sarcoidosis (analysis by Optical Microscopy, Transmission Electron Microscopy and MicroAnalysis).
时间窗: Procedure of bronchoalveolar lavage
次要结局
- Correlation between mineral overload of bronchoalveolar lavage for patient suffering from sarcoidosis and pathological examination of biopsies (analysis by Optical Microscopy, Transmission Electron Microscopy and MicroAnalysis).(Through study completion, an average of 1 year)
- Interest of macrophagic dusting index(Through study completion, an average of 1 year)
- Correlation between mineral overload of bronchoalveolar lavage for patient suffering from sarcoidosis and data extracted from specific Professional and environmental questionnary(Through study completion, an average of 1 year)