About this trial
Interventional study with minimal risks and constraints, with evaluation of the incidence of lung cancers by low-dose thoracic CT scan without injection of contrast medium, of the immunological, inflammatory and metabolic blood profile and of the microbiota; systematic proposal of smoking cessation for active smokers or assistance in maintaining cessation.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
1- All PREVALUNG or PREVALUNG ETOILE participants
2- Active or former smokers who have smoked daily for at least 10 years and have either atheromatous disease (coronary, lower limb, supra-aortic trunk, aortic, visceral or upper limb arteries) or a moderate or high coronary calcium score*, **.
Age 45- 75 years and
Medical follow-up for smoking-related atheromatous pathology and
Disqualifiers
cancer history < 5 years (except carcinoma in situ of the uterine cervix, basal cell carcinoma of the skin, non-invasive urothelial carcinoma treated for curative purposes without CT lung surveillance, prostate cancer with unmeasurable PSA)
symptoms of lung cancer (involuntary weight loss > 7 kg in 1 year, hemoptysis)
known history of pulmonary nodule requiring specialized follow-up
history of pulmonary fibrosis or pulmonary hypertension
Trial design
Single group
Treatments tested in this trial
blood sampling
Diagnostic testblood collection
stool collection
Diagnostic teststool collection
low dose CT scan
Radiationlow dose CT scan evaluation
Treatment groups
Trial outcomes
Primary outcomes
biomarker group validation
Sensitivity and specificity of each biomarker
Secondary outcomes
Describe changes in biomarkers over time
reporting the value of each biomarker at each patient's visit to visit
Describe and compare biomarkers according to clinical characteristics of participants
Value of each biomarker according to the clinical characteristics of participants
Describe changes in quality of life over time
Quality of life (SF-12 score) at each visit.
Describe changes in smoking habits over time
Smoking cessation rate achieved (partial and/or total) among participants active smokers
Sponsors and contacts
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