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:
Describe the population recruited in each step of the protocol
Develop a tool to identify subjects exposed to pulmonary carcinogens and with
high-risk of lung cancer
Evaluate the impact of the proposed screening programme on smoking cessation at one,
two and three years.
Evaluate the social impact of the screening campaign
Conduct a cost-effectiveness analysis of the programme
The proposed study will take place in multidisciplinary and specialized reference centers
(SRC) in various French districts participating in the programme, to welcome patients
participating. It is organized into six workpackages (WP):
WP1: Methodology - Epidemiology
WP2: Evaluation of occupational exposure
WP3: Imaging
WP4: Lung cancer follow-up strategy
WP5: Smoking cessation
WP6: Medico-economic analysis Six specialized reference centers are proposed in four
different regions in order to test a potential region effect and to allow the
recruitment by each SRC of about 200 to 600 new eligible subjects per year and per
department according to the population and the age pyramid of each department
SRC1: Centre Intercommunal de Créteil for the Val-de-Marne (94), Seine-et-Marne
(77), and Essonne (91) departments
SRC2: Bordeaux University Hospital for the Gironde (33) department
SRC3: Rennes University Hospital for the Ille-et-Vilaine (35) department
SRC4: Brest University Hospital for the Finistère (29) department
SRC5: Caen University Hospital for the Calvados (14) department
SRC6: Rouen University Hospital for the Seine-Maritime (76) department
Each of these centers is voluntary and possesses the four essential prerequisites: an
occupational health clinic - radiology team with specific skills in chest imaging -
pulmonology team or network of pulmonologists specialized in lung cancer - smoking
cessation team.
In view of the complexity of this organization, it is proposed to initially test the
feasibility and acceptability of the screening programme sequentially for the first two
years (24 months) in two SRCs (SRC1 and SRC2): "Phase 1: 2021-2023". It is expected to
extend the study to the other SRCs after two years: "Phase 2: 2023-2029". Ad hoc
adjustments will be decided for the creation of SRCs in the third year on the basis of
the data acquired in the two pilot departments, especially on the expected target
population participation rate. Mortality will be monitored at least until 2031.
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.