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NCT06387017
Prospective Multicenter Cohort Study to Validate Four Groups of Biomarkers for Assessing Lung Cancer Risk Among Patients With Atheromatous Cardiovascular Disease in a Screening Pathway
Conditions: Smoking-related Pathology, Atheroma, Non-progressive Cancer > 5 Years, Lung Cancer
Sex: All
Ages: 45 Years – 80 Years
Healthy volunteers: No
Phase: NA
Enrollment: 750
Sponsor: Assistance Publique Hopitaux De Marseille
Location: Assistance Publique Hopitaux de Marseille Marseille
Summary
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
Inclusion Criteria:
* 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\*, \*\*.
Inclusion criteria:
* Age 45- 75 years and
* Medical follow-up for smoking-related atheromatous pathology and
* daily smoking for at least 10 years prior to disease (for smoking, there are no quantitative criteria or withdrawal times)
* visual coronary calcium score quantified by a radiologist on a chest CT scan.
3- Individuals at risk of lung cancer without atheromatous disease or moderate or high calcium score being managed for a tobacco-related disease (chronic bronchitis or non-progressive cancer \> 5 years) or with eligibility criteria for lung cancer screening (inclusion criteria in the NLST or NELSON studies or American recommendations)\*\*.
Inclusion criteria :
* Age 45- 75 and
* Medical follow-up for a smoking-related pathology:
* chronic obstructive pulmonary disease / emphysema, or
* history of non-progressive cancer \> 5 years, including ENT, lung, breast, cervix, excreto-urinary tract, bladder, esophagus, stomach, pancreas, liver, kidney, chronic myeloid leukemia.
and
\- daily smoking for at least 10 years prior to the disease (for smoking, there are no quantitative criteria or withdrawal periods).
Or
Inclusion criteria in NLST :
* Age 55 - 74
* Cumulative smoking ≥ 30 pack-years
* active or weaned for less than 15 years Or
NELSON inclusion criteria :
* Age 50-75
* Smoking :
* \> 15 cigarettes /D for more than 25 years or
* \> 10 cigarettes /D for more than 30 years
* active smoking or cessation \< 10 years Or
American recommendations :
* Age 50 - 80
* Smoking ≥20 PA
Exclusion Criteria:
* 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
* active pulmonary parenchymal infection
* severe cardiac or respiratory insufficiency (rest dyspnea)
* performance status (WHO) 2, 3 or 4
* patient not affiliated to the social security system (beneficiary or beneficiary's beneficiary)
* patient deprived of liberty
* patients under guardianship or trusteeship
* pregnant or breast-feeding women
Source: ClinicalTrials.gov (NCT06387017). StuddyBuddy aggregates publicly available trial information.