Interest of Morphometric Analysis of Sputum Cytology for Lung Cancer Screening in Workers Highly Exposed to Asbestos - Exploratory Analysis of Biomarkers Predictive for Lung Cancer
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 463
- 试验地点
- 6
- 主要终点
- Risk of false positive
研究概览
简要总结
Workers exposed to asbestos are at high risk of lung cancer. Medical follow-up of this population relies on repeated CT-scans which are more accurate for detection of peripheral lesions, and expose to X-rays and to risk of false-positives. Analysis of sputum using automate cytometry may be of interest in this population, alone or in combination with CT-scan.
An ancillary study will evaluate the interest of blood predictive biomarkers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 56 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •High professional asbestos exposure
- •Member of a former cohort recruited between 2000 and 2006 in Caen, Rouen and Le Havre (inclusion criteria: 50-75 years at the time of initial recruitment, high intermittent asbestos exposure >= 1 year, or high discontinuous asbestos exposure >=10 years). All the living members of the cohort will be contacted: a maximum of 1000 subjects is expected, probably less.
- •Informed consent signed
排除标准
- •Personal history of lung cancer
- •Refusal of the study protocol
- •Uncontrolled asthma or lung failure
研究组 & 干预措施
Screening
Paired-design: low-dose CT scan, sputum sample and blood test will be performed on all subjects.
干预措施: low-dose CT-scan AND induced sputum sample AND blood test (Other)
结局指标
主要结局
Risk of false positive
时间窗: within 3 months
Ratio of false positives (RFP) for detection of lung cancer in reference to conventional cytology analysis of sputum
detection of lung cancer
时间窗: within 3 months
Ratio of sensitivities for detection of lung cancer in reference to conventionnal cytology analysis of sputum
次要结局
- Sensitivity for lung cancer detection compared with CT-scan(within 3 months)
- Specificity for detection of lung cancer(within 3 months)
- Predictive Biomarkers(Annually during a maximum of 5 years)