NCT05486455招募中不适用
Evaluation of Lung Cancer CT Screening Performance Among Former and Current Smokers: a "Real Life" Study
Hospital St. Joseph, Marseille, France1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2022年11月4日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Positive Predictive Value (PPV)
研究概览
简要总结
Diagnostic performance of low-dose chest CT scan combined with lung-RADS classification (version 1.1) for lung cancer screening among former and current smokers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female 50-80 years old
- •Active smoker (≥ 15 PA) or former smoker (≥ 15 PA)
排除标准
- •Recent history of chest CT scan (within 12 months)
- •Person unable to climb 2 floors
- •Weight > 140kg
- •Personal history of cancer < 5 years (currently being monitored by thoracic imaging)
结局指标
主要结局
Positive Predictive Value (PPV)
时间窗: 5 years
次要结局
- Penetration rate(5 years)
- 5-year survival rate of patients who have undergone thoracic surgery(5 years)
- Risk ratio of lung cancer(5 years)
- Early stage lung cancer detection rate (stage I and II)(5 years)
- Number of false positive results(5 years)
- Specificity(5 years)
- Sensitivity(5 years)
- Rate of smoking-related co-morbidities detected on low-dose CT scan(5 years)
- Rate of additional examinations (including invasive diagnostic tests and surgery with benign results)(5 years)
- Smoking cessation rates(5 years)
- EORTC QLQ-C30 score (version 3)(5 years)
研究者
研究点 (1)
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