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 now · Not applicable

Conditions studied: Smoking-related Pathology, Atheroma, Non-progressive Cancer > 5 Years, Lung Cancer

In brief

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.

Key facts

Study ID

NCT06387017

Run by

Assistance Publique Hopitaux De Marseille

People needed

750

Starts

2024-04-02

Expected to finish

2029-07-01

Last updated by the study team

2024-04-26

Who can join

Age: 45 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

• Assistance Publique Hopitaux de Marseille — Marseille, France (enrolling)

Full record on ClinicalTrials.gov

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