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
| NCT ID | NCT06387017 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique Hopitaux De Marseille |
| Condition | Smoking-related Pathology |
| Study Type | INTERVENTIONAL |
| Enrollment | 750 participants |
| Start Date | 2024-04-02 |
| Primary Completion | 2028-07 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 750 participants in total. It began in 2024-04-02 with a primary completion date of 2028-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
Contact & Investigator
Mathilde LEFEVRE
STUDY DIRECTOR
ASSISTANCEPUBLIQUE HOPTAUX DE MARSEILLE
Frequently Asked Questions
Who can join the NCT06387017 clinical trial?
This trial is open to participants of all sexes, aged 45 Years or older, up to 80 Years, studying Smoking-related Pathology. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06387017 currently recruiting?
Yes, NCT06387017 is actively recruiting participants. Contact the research team at amandine.rolland@ap-hm.fr for enrollment information.
Where is the NCT06387017 trial being conducted?
This trial is being conducted at Marseille, France.
Who is sponsoring the NCT06387017 clinical trial?
NCT06387017 is sponsored by Assistance Publique Hopitaux De Marseille. The principal investigator is Mathilde LEFEVRE at ASSISTANCEPUBLIQUE HOPTAUX DE MARSEILLE. The trial plans to enroll 750 participants.