Community-based Lung Cancer Screening With Low-dose CT in China (CLUS Study) Version 2.0
试验速览
- 阶段
- 不适用
- 入组人数
- 6,000
- 试验地点
- 1
- 主要终点
- The mortality rate of lung cancer
研究概览
简要总结
Our previous study, china lung cancer screening study version 1.0, had proven that LDCT led to a 74.1% increase in detecting early-stage lung cancer compare to usual care (NCT02898441). The present one arm study is performed to evaluate the efficacy of new techniques in improving the implementation of lung cancer screening and validate our previous findings. 6000 high-risk subjects (age 45-75) were recruited to take LDCT screening. (Baseline + 2 biennial repeated LDCT screening). Follow-up for lung cancer incidence, lung cancer mortality and overall mortality was performed. Blood samples were stored in a Biobank. Management of positive screening test was carried out by a pre-specified protocol.
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
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Eligible participants were those aged 45-75 years, and with either of the following risk factors:
- •history of cigarette smoking ≥ 20 pack-years, and, if former smokers, had quit within the previous 15 years;
- •malignant tumors history in immediate family members;
- •personal cancer history;
- •professional exposure to carcinogens;
- •long term exposure to second-hand smoke;
- •long term exposure to cooking oil fumes.
排除标准
- •Had a CT scan of chest within last 12 months
- •History of any cancer within 5 years
结局指标
主要结局
The mortality rate of lung cancer
时间窗: 5 years
Assess lung cancer mortality within next 5 years after first round of screening
The attendance rate of high-risk individuals
时间窗: 5 year
Evaluate the ability of AI in enhancing the attendance rate of high-risk individuals
Diagnostic accuracy rate of lung cancer
时间窗: 5 year
Evaluate the ability of AI, AFI and molecular biomarkers in enhancing the diagnostic accuracy rate of lung cancer
次要结局
- The detection rate of lung nodules(5 year)
- The mortality of all-cause(5 years)
- The incidence rate lung cancer(5 years)
研究者
Baohui Han
Director
Shanghai Chest Hospital