Implementing Low-dose ct Lung Cancer Screening in France.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Low-dose computed tomography of the chest.
- Who it may be relevant to
- Registry conditions: Lung Cancer. Basic parameters: 50 years — 74 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
The main objective is to estimate the detection rate of lung cancer in the population screened by low-dose chest CT scans.
Detailed description
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.
Interventions
- Procedure Low-dose computed tomography of the chest
Baseline low-dose CT acquisition, then at 1 year and 3 years to depict suspicious lung nodules
Primary outcome measures
- Lung cancer detection rate in the population screened using low-dose chest CT [Time frame: 42 months]
Secondary outcome measures (12)
- Evaluation of screening performance [Time frame: 42 months]
- Exploration and comparison of several methods for identifying and inviting the target population [Time frame: 18 months]
- Measurement of participation rate [Time frame: 18 months]
- Measurement of response rates to follow-up invitations [Time frame: 42 months]
- Measurement of adherence to screening rounds [Time frame: 18 months , 30 months & 54 months]
- Measurement of the complication rate of invasive investigations in positive cases (true positives and false positives) [Time frame: 42 months]
- Measurement of the adherence rate to the offered smoking cessation support [Time frame: 48 months]
- Measurement of the adherence rate to smoking cessation support [Time frame: 48 months]
- Identification of reasons for refusal of smoking cessation support. [Time frame: 48 months]
- Measurement of smoking cessation rate [Time frame: 48 months]
- Identification of the predictors of smoking cessation rates. [Time frame: 48 months]
- Evaluation of the feasibility and relevance of a double reading of CT scans, and role of artificial intelligence [Time frame: 12 months]
Eligibility criteria
Inclusion criteria
- 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
Temporary exclusion Criteria
- 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,…)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Screening
Study locations
France · 2 centers
- HCL - Hôpital Lyon Sud — Lyon
- Hôpital Cochin — Paris
Identifiers
NCT: NCT07513818 · APHP250243 · ID-RCB Number