Adherence to Lung Cancer Screening by Low-dose Thoracic CT in Haut-Rhin Department, France.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 126
- 试验地点
- 2
- 主要终点
- Rate of included patients having undergone the first screening scan
研究概览
简要总结
The main objective of the study is to measure adherence to a lung cancer screening program using low-dose thoracic CT.
详细描述
Secondary objectives
- To evaluate patient compliance over the entire duration of the screening program
- To assess patient smoking cessation
- To describe radiation doses received during CT scans
- To identify organizational constraints for general practitioners
- To compare stages at diagnosis before and after implementation of screening program
Conduct of research Eligible patients will be identified by general practitioners. Patients included will require a low-dose thoracic CT scan to be performed by a radiologist of their choice. Smoking cessation will be systematically proposed, and will be carried out by the general practitioner or a tobaccologist.
The radiation dose from thoracic CT scans should not exceed 100 mGy.cm Product Dose Length (i.e. < 1.5 mSv). Imaging reports will be forwarded to the general practitioner.
If the first CT scan is negative (T0): a second scan will be scheduled 1 year later (T1). If this second scan is also negative, in the absence of lung cancer risk factors other than smoking, scans will then be performed every two years. In the presence of a risk factor for lung cancer (other than tobacco), screening will remain annual.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 50 to 74 years
- •Smoking OR having smoked (withdrawal of <15 years): ≥15 cigarettes/day for ≥25 years OR ≥10 cigarettes/day for ≥30 years
- •Affiliated or beneficiary of a social security scheme
- •Written informed consent
排除标准
- •Inability to walk up two flights of stairs without stopping
- •BMI > 35 kg/m²
- •Recent chest CT scan < 1 year
- •Personal history of lung cancer < 5 years or under treatment
- •Personal history of cancer being monitored by chest CT scan
- •Contraindication to lung cancer treatment or diagnostic investigations
- •Current or recent respiratory symptoms immediately suggestive of lung cancer
- •Pregnant or breast-feeding woman
- •Person under court protection, guardianship or curatorship
- •Person deprived of liberty by judicial or administrative decision.
研究组 & 干预措施
Patients with a high risk of lung cancer
干预措施: Low Dose chest CT Scan for Lung Cancer Screening (Procedure)
结局指标
主要结局
Rate of included patients having undergone the first screening scan
时间窗: T0
次要结局
- Tobacco consumption(3 years)
- Rate of patients who refused to participate in the screening program(1 year)
- Radiation doses received at each CT scan(3 years)
- Organizational constraints of the screening program(before starting the study)
- Rate of included patients having completed CT scans at each stage of follow-up(3 years)
- Number of patients newly committed to smoking cessation during the screening period(3 years)
- Stage at diagnosis (TNM classification) of patients with lung cancer(3 years)