Lung Cancer Screening With Low-dose CT Scan in Women : Implementation Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,635
- 试验地点
- 2
- 主要终点
- Performance of trained radiologists for lung cancer screening
研究概览
简要总结
The purpose of this study is to determine whether reading of low-dose thoracic CT scans can be done by a single general radiologist who has been trained to lung cancer screening, and will evaluate the performance in comparison with double reading by experts.
The study will enroll women between 50 and 74 years old, at risk for lung cancer due to their smoking history.
详细描述
Lung cancer is the leading cause of cancer death, worldwide. Several randomized studies have demonstrated that annual or biennial low-dose CT screening reduces lung cancer mortality. However, these studies involved expert chest radiologists, with double reading being performed in most studies. Furthermore, none of the published studies have evaluated the role of artificial intelligence to serve as second of concurrent reader.
Women with at least 20 pack-year smoking history who quitted smoking less than 15 years ago will be enrolled to have baseline, 1-year and 2-year low-dose CT of the chest.
The CT scans will be read on site by a general radiologist trained to lung cancer screening according to the European lung cancer screening certification program, first without then with the aid of an artificial algorithm trained to lung nodule detection (Veye Chest, Aidence). All CT scans will also be read by 2 chest experts, who will resolve their disagreement by a consensus reading if necessary. Patient management will rely on the double reading by expert. The criteria for positive screen result are as follows: solid nodule > 500 mm3 (10 mm) or growing (30% volume increase), part-solid nodule with > 8 mm solid component or new or growing, pure ground glass nodule developing a solid portion.
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 74 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged from 50 to 74 years
- •who had smoked at least 20 pack years and quit less than 15 years ago
- •Had given their consent and accepted the need for a 2-year follow-up
- •Affiliated to the social security system
- •Exclusion Criteria
- •Presence of clinical symptoms suggesting malignancy (weight loss, hemoptysis) or ongoing infection (cough with fever)
- •Evolving cancer
- •History of lung cancer
- •A 2-year follow-up not possible
- •Chest CT scan performed within 2 years prior to inclusion
排除标准
- 未提供
结局指标
主要结局
Performance of trained radiologists for lung cancer screening
时间窗: 2 years
Sensitivity, specificity, predictive values compared to double reading by experts
次要结局
- Analysis of the performance of a reading by detection software alone(2 years)
- Adherence to screening(2 years)
- Analysis of the impact of screening on smoking cessation(2 years)
- Psychological impact of screening(2 years)
- Number of co-morbidities (COPD, coronary artery disease) detected(2 years)
- Effectiveness of screening(2 years)
- Analysis of the diagnostic performance of the reading without detection software, in order to assess its incremental value(2 years)
- Analysis of the concordances of the different readings(2 years)
- Evaluation of costs induced by screening(2 years)
- Prevalence of osteoporosis by opportunistic screening(2 years)