Optimizing the Implementation of Bronchopulmonary Cancer Screening in the Ile de France Region (OPTI-DEPIST-MUT)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 17
- 主要终点
- Rate of first CTscan for bronchopulmonary cancer screening
研究概览
简要总结
The aim of this study is to evaluate the feasibility of performing a first screening for bronchopulmonary cancer by thoracic scanner in a French cohort within a dedicated, effective and structured network in the pilot centers participating in the study.
详细描述
The organization of bronchopulmonary cancer screening in the Ile de France region, within the Mutualists and its affiliated health centers, is based on a clear, simple and functional process:
- Definition of eligibility criteria for screening, based on those of the NELSON study,
- Referral and consultation by a health center physician trained in these criteria,
- Referral and performance of a chest Computer Tomography Scanner (CTscan) according to the same recommendations,
- Structured centralized reading and interpretation of CTscan images,
- Referral to a multidisciplinary team (CITT), if bronchopulmonary cancer is suspected,
- Referral to a tobacco unit in a health center for smokers who have not stopped smoking,
- Organization of follow-up and continuation of the screening program.
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
- •Participant aged 50 to
- •Resident in the Île-de-France region.
- •Active smoker or quit smoker for 10 years or less:
- •more than 10 cigarettes a day for more than 30 years,
- •more than 15 cigarettes a day for more than 25 years.
- •The participant has been informed and has signed the consent form.
- •Social Security System affiliation.
- •Willingness to participate in a smoking cessation program, if currently smoking.
排除标准
- •Active cancer or a history of cancer in remission for less than 5 years (except basal cell carcinoma of th skin or epithelioma in situ of the uterine cervix).
- •Presence of symptoms suggestive of bronchopulmonary cancer. Participants with these symptoms require immediate diagnostic investigations and are therefore not eligible for screening.
- •Weight >= 140 kg.
- •Severe comorbidity contraindicating therapeutic options or invasive thoracic diagnostic investigations.
- •Inability to climb two flights of stairs without stopping.
- •A thoracic CTscan performed within the previous year.
- •Persons deprived of liberty or under guardianship.
- •Impossibility to undergo the medical monitoring of the trial for geographical, social or psychological reasons.
研究组 & 干预措施
Screening for primary prevention of bronchopulmonary cancer
Screening CTscan according to the NELSON trial schedule (at inclusion, 1 year, 3 years, 5.5 years),
干预措施: Screening (Other)
Screening for primary prevention of bronchopulmonary cancer
Screening CTscan according to the NELSON trial schedule (at inclusion, 1 year, 3 years, 5.5 years),
干预措施: Inclusion (Other)
Screening for primary prevention of bronchopulmonary cancer
Screening CTscan according to the NELSON trial schedule (at inclusion, 1 year, 3 years, 5.5 years),
干预措施: Chest CTscan and follow-up (Other)
结局指标
主要结局
Rate of first CTscan for bronchopulmonary cancer screening
时间窗: 36 months
Rate of completion of a first bronchopulmonary cancer screening among people who have joined the program (i.e. registered on the program's web platform and met the inclusion criteria).
次要结局
- Rate of completion of screening scanners at 3 years according to NELSON trial schedule(72 months)
- Correlation of demographic characteristics and the detection of a nodule during the 4 CTscan(102 months)
- Smoking cessation rates during the screening program(102 months)
- Rate of positive screening without bronchopulmonary cancer(102 months)
- Rate of completion of screening scanners at 5.5 years according to NELSON trial schedule(102 months)
- Rate of early-stage bronchopulmonary cancers identified(102 months)
- Eligibility rate among people registering on the web platform(36 months)
- Rate of completion of screening scanners at 1 year according to NELSON trial schedule(48 months)
- Rate of completion of the inclusion visit among people registered on the web platform,(36 months)
- Rate of complications related to complementary explorations(102 months)