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
Recruiting · NCT06387017 · Interventional (participants receive a specific treatment) · Lead sponsor: Assistance Publique Hopitaux De Marseille
View the official record on ClinicalTrials.gov →Interventions studied
blood samplinglow dose CT scanstool collection
What this trial is about
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.
Who can take part
Age range
45 Years to 80 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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.
- 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).
- 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
Where it is running
1 location listed.
- Assistance Publique Hopitaux de Marseille - Marseille, France