Interventional study with minimal risks and constraints, involving annual assessment of the prevalence and incidence of lung cancer using low-dose contrast-free thoracic CT scans, immunological, inflammatory, metabolic, blood nucleic acid and digestive microbiota profiles; systematic proposal of smoking cessation for active smokers, or assistance in maintaining cessation This is a prospective validation study of risk stratification tools still under development. The results of this study will be used to design medical devices (software integrating risk stratification tools), which will then be evaluated as part of subsequent Clinical Investigations.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Enrollment
900
blood draw at each time point
low dose lung scan will be performed at each timepoint
Sensitivity and specificity of the radiomics algorithm for characterizing benign vs. malignant lung lesions.
Time frame: 30 months
Sensitivity and specificity of minimal biological panel based on markers of inflammation, immunity, blood metabolism and stool metagenomics for characterization of benign vs. malignant lung lesions.
Time frame: 30 months
Sensitivity and specificity of new biomarkers including specific antibodies and circulating nucleic acids for characterization of benign vs. malignant lung lesions.
Time frame: 30 months
Sensitivity and specificity of a patho-radiomic-based algorithm quantifying the risk of recurrence of operated lung cancers.
Time frame: 30 months
Sensitivity and specificity of minimal and novel biomarker panels for the prediction of postoperative lung cancer recurrence.
Time frame: 30 months
Description of biomarker panels among people not eligible for lung cancer screening.
Time frame: 30 months
Change over time in biomarkers overall, then in each of the following subgroups: - people undergoing lung cancer surgery - smoking cessation patients - people with an incident diagnosis of lung cancer
Time frame: 30 months
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