LUng Cancer Screening With Low-dose Computed Tomography in a Population Exposed to Occupational Lung Carcinogens
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 6,000
- 试验地点
- 8
- 主要终点
- Rate of detected lung cancer
研究概览
简要总结
The good clinical practice guidelines for the surveillance of workers after occupational exposure to lung carcinogens were approved by the Haute Autorité de la Santé (French National Authority for Health) and the Institut National du Cancer (French National Cancer Institute) in December 2015 and one recommendation of these guidelines concerns the setting-up of a trial of low-dose chest computed tomography (CT) lung cancer screening in subjects occupationally exposed to lung carcinogens at high-risk of lung cancer (Expert consensus).
In LUCSO study, the investigators propose to conduct, under strictly defined conditions, a feasibility study of lung cancer screening in a population defined as being at high risk of lung cancer according to these good clinical practice guidelines. This population consists of smokers, aged from 55 to 74 years, currently or previously exposed to International Agency for Research on Cancer lung group 1 lung carcinogens.
The primary objective of this study is to evaluate the complex organization of lung cancer screening in the target population. This evaluation will focus on the following indicators:
- Screening activity indicator: screening coverage rate over two years
- Test quality indicator: validity of self-administered questionnaires to target the high-risk population
- Examination quality indicator: lung cancer detection rate, lung cancer detection rates by stage, validity of low-dose chest CT scan
- Follow-up indicator: smoking cessation rate, mortality rate This trial will be conducted in 8 French departments, by six reference centers specialized in occupational health (SRC).
In view of the exploratory nature of this trial, it is proposed to initially test the feasibility and acceptability of lung cancer screening sequentially over the first two years (Phase 1: 2021-2023, 24 months) in only two SRC (Val-de-Marne and Gironde).
The trial will be conducted in several steps:
- Identification of subjects currently or previously occupationally exposed to lung carcinogens by a screening invitation letter sent by Departmental Cancer Screening Centers to subjects aged from 55 to 74 years.
- Evaluation of occupational exposure to lung carcinogens
- Evaluation of the lung cancer risk level and verification of eligibility
- Screening procedure: Chest CT scans will be performed by centers specialized in chest imaging
- Lung cancer follow-up when an abnormality suggestive of lung cancer is demonstrated.
详细描述
The good clinical practice guidelines for the surveillance of workers after occupational exposure to lung carcinogens were approved by the Haute Autorité de la Santé (French National Authority for Health) and the Institut National du Cancer (French National Cancer Institute) in December 2015 and the Recommendation R12 of these guidelines concerns the setting-up of a trial of low-dose chest computed tomography (CT) lung cancer screening in subjects occupationally exposed to lung carcinogens at high-risk of lung cancer (Expert consensus).
In LUCSO study, the investigators propose to conduct, under strictly defined conditions, a feasibility study of lung cancer screening in a population defined as being at high risk of lung cancer according to these good clinical practice guidelines. This population consists of smokers, aged from 55 to 74 years, currently or previously exposed to International Agency for Research on Cancer lung group 1 lung carcinogens.
The primary objective of this study is to evaluate the organization of lung cancer screening in the target population. This evaluation will focus on the following indicators:
- Screening activity indicator: screening coverage rate over two years
- Test quality indicator: validity of self-administered questionnaires to target the high-risk population
- Examination quality indicator: lung cancer detection rate, lung cancer detection rates by stage, validity of low-dose chest CT scan
- Follow-up indicator: smoking cessation rate, mortality rate
The secondary objectives of the study are:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 55 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects at high risk of lung cancer: current smokers smoking 30 pack-years or more or ex-smokers smoking 30 pack-years or more and who have quit smoking for less than 15 years and currently or previously occupationally exposed to lung carcinogens. With an algorithm for determination of minimal duration of exposure to occupational carcinogens (according to the type and duration of occupational lung carcinogens)
排除标准
- •Presence of clinical signs of lung cancer
- •Subjects with a history of lung cancer
- •Presence of serious short-term life-threatening comorbidities
- •Absence of occupational exposure to lung carcinogens according to the predefined criteria
- •Subjects already included in another prospective cohort study
- •Subjects already assessed by chest CT scan during the previous year
- •No tobacco exposure or insufficient tobacco exposure or smoking cessation for more than 15 years.
结局指标
主要结局
Rate of detected lung cancer
时间窗: Year 1
The proportion of subjects with lung cancer detected among the subjects performing the low-dose chest CT scan
次要结局
- Number of hospitalizations(Year 5)
- Number of lung surgery(Year 5)
- Rate of detected lung cancer(Day 0)
- Rate of detected lung cancer in subjects exposed to occupational carcinogens(Year 2)
- Number of cases recognized as occupational disease (for lung cancer or other occupational diseases)(Year 2)
- Participation rate(Day 0)
- Stage of detected lung cancers(Year 2)
- Lung cancer rate in non-screened subjects but met at the Occupational Disease Consultation Center(Year 7)
- Smoking cessation rate obtained in smokers in the sreened population(Year 3)
- Mortality rate in the sreened population(Year 7)
- Mortality rate in the non-screened population(Year 7)
- Rate of detected lung cancer and stage of detected lung cancer in the non-screened population(Year 7)
- Percentage of subjects participating in all screening (over the three years)(Year 4)
- Validity of the detailed personalised self-administered questionnaire for the evaluation of occupational exposures(Day 0)
- Percentage of the subjects lost during follow-up in the screened population (follow-up at one year, two years, completion of other complementary exams)(Year 2)
- Proportion of invasive diagnostic procedures(Year 2)
- Proportion of non-invasive diagnostic procedures(Year 2)
- Number of additional radiological examinations performed besides the prescribed CT scans of the protocol(Year 5)
- Proportion of serious and non-serious adverse events related to screening(Year 2)
- Proportion of subjects stopping smoking at each stage of screening(Year 2)
- The time period between each step of the screening (evaluation of the exposure, addressing in consultation of occupational diseases, inclusion, different exams of the follow-up)(Year 3)
- Number of chemotherapy(Year 5)