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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: patients with a nodule or lung mass identified on CT scan, with no indication of an immedi | Other | patients with a nodule or lung mass identified on CT scan, with no indication of an immediate diagnostic workup |
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| Group B: cohort of patients with a nodule or lung mass identified on CT with an indication for biops | Other | cohort of patients with a nodule or lung mass identified on CT with an indication for biopsy or excision surgery |
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| Group C: Individuals with at least one risk factor for lung cancer and no prior lung imaging, but no | Other | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| biobanking | Biological | blood draw at each time point |
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| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity and specificity of the radiomics algorithm for characterizing benign vs. malignant lung lesions. | 30 months |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity and specificity of minimal biological panel based on markers of inflammation, immunity, blood metabolism and stool metagenomics for characterization of benign vs. malignant lung lesions. | 30 months | |
| Sensitivity and specificity of new biomarkers including specific antibodies and circulating nucleic acids for characterization of benign vs. malignant lung lesions. |
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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 :
All Groups:
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
All Groups
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| David Boulate, Professor | Contact | +33 491966018 | david.boulate@ap-hm.fr |
| Name | Affiliation | Role |
|---|---|---|
| David Boulate, Professor of Medicine | Assistance Publique Hopitaux De Marseille | Principal Investigator |
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| low dose scan | Radiation | low dose lung scan will be performed at each timepoint |
|
| 30 months |
| Sensitivity and specificity of a patho-radiomic-based algorithm quantifying the risk of recurrence of operated lung cancers. | 30 months |
| Sensitivity and specificity of minimal and novel biomarker panels for the prediction of postoperative lung cancer recurrence. | 30 months |
| Description of biomarker panels among people not eligible for lung cancer screening. | 30 months |
| Change over time in biomarkers overall, then in each of the following subgroups: - people undergoing lung cancer surgery - smoking cessation patients - people with an incident diagnosis of lung cancer | 30 months |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D004194 | Disease |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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