Use of Anti-CD146 Autoantibodies for the Diagnosis of Pulmonary Diseases Secondary to Occupational Exposure to Silica
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 110
- 主要终点
- Prevalence ratio of AACD146 between the exposed and non-exposed groups.
研究概览
简要总结
This prospective, multicenter study aims to evaluate the relevance of anti-CD146 autoantibodies (AACD146) as biological markers for the early diagnosis of pulmonary diseases related to occupational exposure to silica. Silica exposure is a recognized risk factor for fibrotic, inflammatory, and cancerous respiratory diseases. Currently, no specific biological marker exists. The hypothesis is that AACD146 reflects early effects of silica exposure. The study will include 110 participants divided into two groups (exposed vs. non-exposed) and will compare AACD146 prevalence according to exposure level and the presence of respiratory diseases.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- •for non-exposed group:
- •Subject, male or female, aged 18 or over
- •Subject with low exposure to silica <0.1 mg/m3 in the course of their professional activity, quantified during an occupational health consultation using an employment-exposure matrix
- •Subjects capable of consenting to participate in the study by signing a written informed consent form
- •Subjects who are beneficiaries of or affiliated with a social security system
- •Inclusion Criteria for exposed group:
- •Subject, male or female, aged 18 or over
- •Subject with moderate or high exposure to silica (>= 0.1 mg/m3) in the course of their professional activity, quantified during an occupational health consultation using an employment-exposure matrix.
- •Subjects capable of consenting to participate in the study by signing a written informed consent form
- •Subjects who are beneficiaries of or affiliated with a social security system
排除标准
- •for each group:
- •Minor subject
- •Subject refusing to undergo the examinations required by the protocol
- •Contraindications to respiratory function tests: Recent eye or throat surgery, recent myocardial infarction or pulmonary embolism, poorly controlled high blood pressure, recent pneumothorax.
- •Pregnant or breastfeeding women, patients under guardianship or curatorship, deprived of liberty
研究组 & 干预措施
Non-exposed
Subject with low exposure to silica <0.1 mg/m3 in the course of their professional activity
干预措施: Respiratory function testing (Other)
Non-exposed
Subject with low exposure to silica <0.1 mg/m3 in the course of their professional activity
干预措施: blood sampling (Biological)
Exposed
Subject with moderate or high exposure to silica (>= 0.1 mg/m3) in the course of their professional activity
干预措施: Respiratory function testing (Other)
Exposed
Subject with moderate or high exposure to silica (>= 0.1 mg/m3) in the course of their professional activity
干预措施: blood sampling (Biological)
Exposed
Subject with moderate or high exposure to silica (>= 0.1 mg/m3) in the course of their professional activity
干预措施: CT scan (Radiation)
结局指标
主要结局
Prevalence ratio of AACD146 between the exposed and non-exposed groups.
时间窗: At enrollment
次要结局
- AACD146 prevalence in patients with interstitial or neoplastic lung disease.(At enrollment)
- AACD146 Prevalence by type of interstitial lung disease(At enrollment)
- AACD146 Prevalence by type of histological type of lung cancer.(At enrollment)
- Correlation between AACD146 and exposure duration and dose to silica(At enrollment)
- Correlation between AACD146 and soluble CD146(At enrollment)