Implementing Low-dose ct Lung Cancer Screening in France.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20,000
- 试验地点
- 2
- 主要终点
- Lung cancer detection rate in the population screened using low-dose chest CT
研究概览
简要总结
The main objective is to estimate the detection rate of lung cancer in the population screened by low-dose chest CT scans.
详细描述
Low-dose CT screening (LDCT) allows for the detection of lung cancer at an early stage, enabling curative treatment. Large randomized controlled trials have demonstrated that LDCT reduces mortality in smokers.
The objective of the current research is not to confirm a reduction in mortality, but to show that screening can be safely implemented at a population level. Different modes of recruitment and invitation will be tested to ensure that LDCT can be implemented equitably. The role of artificial intelligence as an alternative to double human reading will also be assessed.
Screening strategy includes baseline, followed by 1-year LDCT, and a third LDCT 2 years later. Current smokers will be offered smoking cessation support.
The management of screen-detected lung nodules will follow the 2025 guidelines from the European Society of Thoracic imaging.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 50-74 years
- •Active or former smoker having quit less than 15 years ago
- •Smoking history of at least 20 pack-years, or 15 cigarettes/day for 25 years or 10 cigarettes/day for 30 years
- •Affiliation with a social security scheme
- •Written informed consent prior to study participation
排除标准
- •Chest CT scan performed within the previous 12 months
- •Signs of respiratory infection (fever, productive cough)
- •Exclusion Criteria:
- •Severe co-morbidities contraindicating exploration and/or management (including stereotactic surgery or radiotherapy) of lung cancers
- •Poor general status (PS2 and above)
- •Rest dyspnea (mMRC4)
- •Cancer under active surveillance by thoracic computed tomography (CT pr PET-CT)
- •Personal history of lung cancer
- •Symptoms raising suspicion of lung cancer (hemoptysis, unexplained weight loss, recent onset or modification of respiratory symptoms,…)
结局指标
主要结局
Lung cancer detection rate in the population screened using low-dose chest CT
时间窗: 42 months
Number of individuals with detected cancer divided by the number of individuals included in the study, i.e., an intention-to-screen analysis.
次要结局
- Evaluation of screening performance(42 months)
- Exploration and comparison of several methods for identifying and inviting the target population(18 months)
- Measurement of participation rate(18 months)
- Measurement of response rates to follow-up invitations(42 months)
- Measurement of adherence to screening rounds(18 months , 30 months & 54 months)
- Measurement of the complication rate of invasive investigations in positive cases (true positives and false positives)(42 months)
- Measurement of the adherence rate to the offered smoking cessation support(48 months)
- Measurement of the adherence rate to smoking cessation support(48 months)
- Identification of reasons for refusal of smoking cessation support.(48 months)
- Measurement of smoking cessation rate(48 months)
- Identification of the predictors of smoking cessation rates.(48 months)
- Evaluation of the feasibility and relevance of a double reading of CT scans, and role of artificial intelligence(12 months)
- Measurement of the detection rate of coronary artery calcifications, pulmonary emphysema, osteoporosis, and incidental findings(24 months)
- Panel characteristics of participants(48 months)
- Impact of the program on healthcare pathways(42 months)
- Comparison of healthcare pathways(42 months)
- Creation of a CT scan dataset(42 months)
- Definition of a lung cancer risk score(42 months)
- Cost effectiveness analysis(42 months)
- Panel - participant perceptions(48 months)
- Ultra low-dose(1 day (baseline scanner))
- Biobank(Inclusion (day 1))
- Spirometry(Inclusion (day 1))