Community-based Early Stage Lung Cancer Screening With Low-dose Computed Tomography in China
试验速览
- 阶段
- 不适用
- 入组人数
- 6,000
- 试验地点
- 1
- 主要终点
- Lung cancer incidence rate
研究概览
简要总结
The present study is a randomized controlled trial of LDCT screening for lung cancer versus usual care. 6000 high-risk subjects (age 45-70) were recruited and randomized to the Active arm (Baseline + 2 biennial repeated LDCT screening) or to the Passive arm, followed up in usual care (Baseline + 2 biennial repeated questionnaire inquiries). Follow-up for lung cancer incidence, lung cancer mortality and overall mortality was performed. Blood samples were stored from the Active arm 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
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Eligible participants were those aged 45-70 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
Lung cancer incidence rate
时间窗: 5 years
Assess the number of lung cancer incidences after each round of screening in both arms. Compared the stage differences between screening arm and usual care arm.
次要结局
- All-cause mortality(5 years)
- Lung cancer mortality(5 years)
研究者
Baohui Han
Vice-President
Shanghai Chest Hospital