Early Detection of Lung Cancer - A Pan Canadian Study
试验速览
- 阶段
- 不适用
- 入组人数
- 2,504
- 试验地点
- 12
- 主要终点
- Number of lung cancer cases detected early by spiral CT scan and autofluorescence bronchoscopy
研究概览
简要总结
RATIONALE: Screening may help doctors find lung cancer sooner, when it may be easier to treat.
PURPOSE: This clinical trial is studying screening methods to see how well they find lung cancer early in current or former smokers.
详细描述
OBJECTIVES:
- To develop a new multi-modal screening strategy and integrated methods to detect lung cancer early in current and former smokers.
- To evaluate the impact of the screening modalities on the quality of life of these participants.
- To develop a decision analytic framework for determining the cost and effectiveness of a novel lung cancer screening strategy in Canada.
OUTLINE: This is a multicenter study.
Participants undergo spirometry at baseline. Participants also undergo spiral CT scan at baseline and then at 1 and 2 years. Participants with semi-solid or solid nodules of 5-10 mm or ground glass opacity (GGO) 8-10 mm or those with growth of an existing nodule, development of a solid component in GGO, or a new nodule undergo an additional CT scan at 3 months. Some participants also undergo autofluorescence and white light bronchoscopy and bronchial biopsies.
Blood samples are collected at baseline and then annually for 2 years for biomarker studies. Participants diagnosed with lung cancer undergo additional blood sample collection for biomarker studies.
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
- None
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Current or former smoker
- •A former smoker is defined as one who has stopped smoking ≥ 1 year but < 15 years ago
- •Estimated 1-year lung cancer risk ≥ 1%
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-1
- •Not pregnant
- •Willing to undergo a spiral chest CT scan
- •No severe heart disease (e.g., unstable angina or chronic congestive heart failure)
- •No acute or chronic respiratory failure
- •No bleeding disorder
- •No other medical condition that, in the opinion of the investigator, would preclude the participant's safety during study participation or that would unlikely benefit the participant from screening due to shortened life expectancy from the co-morbidity
- •No diagnosis of cancer, except for any of the following that were previously treated ≥ 5 years ago:
- •Non-melanomatous skin cancer
- •Localized prostate cancer
- •Carcinoma in situ of the cervix
- •Superficial bladder cancer
- •No known reaction to xylocaine, salbutamol, midazolam, or alfentanil
- •PRIOR CONCURRENT THERAPY:
- •More than 2 years since prior chest CT scan
- •No concurrent anti-coagulant treatment (e.g., warfarin or heparin)
排除标准
- 未提供
结局指标
主要结局
Number of lung cancer cases detected early by spiral CT scan and autofluorescence bronchoscopy
时间窗: 24 months
Number of interval lung cancer cases
时间窗: 60 months
次要结局
- Stage distribution of lung cancer cases(60 months)
- Prevalence of lung nodules and differences in geographic distribution across Canada(60 months)
- Rate of detection of other incidental significant treatable diseases(60 months)
- Type and costs of downstream investigation and treatment related to abnormalities found by the screening procedures, whether the final diagnosis is lung cancer or not(60 months)
- Potential physical and psychosocial impact on participants(60 months)