Prospective Multicenter Cohort Study for the Development and Evaluation of Risk Stratification Tools for Lung Cancers and Their Postoperative Recurrences Using Multimodal Clinical, Radiological, Tissue and Longitudinal Biological Phenotyping Among People at Risk of Lung Cancer

NCT ID: NCT07042867

Last Updated: 2025-06-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 900 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-15
• Study Completion Date: 2028-01-15

Brief Summary

Interventional study with minimal risks and constraints, involving annual assessment of the prevalence and incidence of lung cancer using low-dose contrast-free thoracic CT scans, immunological, inflammatory, metabolic, blood nucleic acid and digestive microbiota profiles; systematic proposal of smoking cessation for active smokers, or assistance in maintaining cessation This is a prospective validation study of risk stratification tools still under development.

The results of this study will be used to design medical devices (software integrating risk stratification tools), which will then be evaluated as part of subsequent Clinical Investigations.

Conditions

Lung Cancer (Diagnosis)

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

Group A: patients with a nodule or lung mass identified on CT scan, with no indication of an immedi

patients with a nodule or lung mass identified on CT scan, with no indication of an immediate diagnostic workup

Group Type: OTHER

biobanking

Intervention Type: BIOLOGICAL

blood draw at each time point

low dose scan

Intervention Type: RADIATION

low dose lung scan will be performed at each timepoint

Group B: cohort of patients with a nodule or lung mass identified on CT with an indication for biops

cohort of patients with a nodule or lung mass identified on CT with an indication for biopsy or excision surgery

Group Type: OTHER

biobanking

Intervention Type: BIOLOGICAL

blood draw at each time point

low dose scan

Intervention Type: RADIATION

low dose lung scan will be performed at each timepoint

Group C: Individuals with at least one risk factor for lung cancer and no prior lung imaging, but no

Individuals with at least one risk factor for lung cancer and no prior lung imaging, but not eligible for lung cancer screening according to INCa criteria.

Group Type: OTHER

biobanking

Intervention Type: BIOLOGICAL

blood draw at each time point

low dose scan

Intervention Type: RADIATION

low dose lung scan will be performed at each timepoint

Interventions

biobanking

blood draw at each time point

Intervention Type: BIOLOGICAL

low dose scan

low dose lung scan will be performed at each timepoint

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

Group A:

CI 1- Age > 18 years AND CI2a- Person eligible for screening with a nodule or lung mass with no indication of reassessment by CT scan before the next round of screening, as recommended by the multidisciplinary consultation meeting OR CI2b- Person not eligible for screening with a nodule or lung mass with an indication for reassessment by CT scan without immediate diagnostic workup (PET scan, biopsy, surgery) as determined by the multidisciplinary consultation meeting.

Group B CI1- Age > 18 years AND CI2- Indication for biopsy or surgical excision for diagnostic and therapeutic purposes proposed in a multidisciplinary consultation meeting.

Group C CI1a- Age 40 - 75 and daily smoking for at least 20 years initiated before age 15 OR CI1b- Age 50 - 75 and passive smoking for at least 20 years in a closed environment (family or workplace) OR CI1c- Age 50 - 75 and smoking 10 cig/d for 30 years or 15 cig/d for 25 years or 20 pack-years with no withdrawal period OR

CI1d- Age 50 - 75 and daily smoking for at least 10 years combined with at least one other lung cancer risk factor from among :

• Self-reported daily passive smoking for > 10 years (smokers at home or in enclosed environments)
• Self-reported exposure to a lung carcinogen: Radon, coal smoke, soot, diesel, nickel, beryllium, arsenic, cadmium, asbestos
• 1st-degree family history of lung cancer
• Personal history of tobacco-related disease, including atheromatous cardiovascular disease, COPD or emphysema, cancer not monitored by chest imaging
• weekly use of cannabis (joints) for 10 years

All Groups:

• Have signed an informed consent form
• Affiliated with or benefiting from a social security scheme
• Male or female

Exclusion Criteria

Goups A and B Contraindication to lung biopsy or thoracic surgery for diagnostic or therapeutic purposes

Group C Eligible for lung cancer screening according to INCa* criteria

• Previous cancer < 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 undiagnosable PSA)
• Symptoms of lung cancer (involuntary weight loss > 10% of usual weight 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

All Groups

• patient privé de liberté
• patient sous tutelle ou curatelle
• femmes enceintes ou allaitantes
• patient dans l'incapacité d'effectuer le suivi de 30 mois

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Boulate, Professor of Medicine

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique Hopitaux De Marseille

Central Contacts

David Boulate, Professor

Role: CONTACT

david.boulate@ap-hm.fr

+33 491966018

Other Identifiers

2024-A02828-39

Identifier Type: -

Identifier Source: org_study_id