Structuring of a Lung Cancer Screening Program Including Clinical, Radiological and Biological Phenotyping Useful for the Development of Individualized Risk Prediction Tools: PREVALUNG ETOILE

Study Overview
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Brief Summary
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Patients treated at the Hôpital Nord de Marseille for at least one smoking-related pathology (atheroma, chronic bronchitis, non-progressive cancer > 5 years) or with eligibility criteria for lung cancer screening (inclusion criteria in the NLST or NELSON studies or American recommendations) Interventional study with minimal risks and constraints, with evaluation of lung cancer prevalence; immunological, blood inflammatory and microbiota profile Determine the maximum clinical, radiological, and biological phenotyping completeness rate following the implementation of a new lung cancer screening care pathway with multidimensional clinical, radiological, and biological phenotyping capabilities

Official Title
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Structuring of a Lung Cancer Screening Program Including Clinical, Radiological and Biological Phenotyping Useful for the Development of Individualized Risk Prediction Tools: PREVALUNG ETOILE

Conditions
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Smoking-related Pathology, Atheroma, Chronic Bronchitis, Non-progressive Cancer > 5 Years, Lung Cancer

Intervention / Treatment
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* Device: thoracic scan Low dose
* Biological: BLOOD SAMPLE
* Biological: FECES SAMPLE


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 45- 75 years and Medical follow-up for a smoking-related pathology : atheroma chronic obstructive pulmonary disease / emphysema history of non evolving cancer > 5 years among: ENT, lung, breast, cervical, excreto-urinary cervix, excreto-urinary tract, bladder, esophagus, stomach, pancreas, liver, kidney, chronic myeloid leukemia chronic myeloid leukemia, daily smoking for at least 10 years prior to the disease Or NLST inclusion criteria: Age 55 - 74 years Cumulative smoking ≥ 30 pack-years active or quit for less than 15 years Or Inclusion criterion in NELSON: Age 50-75 years 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 New American recommendations : Age 50 - 80 years Smoking ≥20 PA Active or weaned <15 years Exclusion Criteria: history of cancer < 5 years (except carcinoma in situ of the uterine cervix, basal cell skin carcinoma basal cell carcinoma of the skin and prostate cancer with undetectable PSA) Symptoms of lung cancer (unintentional weight loss > 7 kg in 1 year, hemoptysis) known history of pulmonary nodule with specialized follow-up history of pulmonary fibrosis or pulmonary hypertension patient under guardianship or curatorship active pulmonary parenchymal infection severe cardiac or respiratory insufficiency (rest dyspnea) patient not affiliated to the social security system (beneficiary or beneficiary's right) Patient deprived of liberty Performance status (WHO) 2, 3 or 4 Pregnant or breastfeeding women

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: patients<br> | Device: thoracic scan Low dose<br>* within 3 months after the V0 visit<br>Biological: BLOOD SAMPLE<br>* within 3 months after the V0 visit<br>Biological: FECES SAMPLE<br>* within 3 months after the V0 visit<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of complete phenotyping clinical, clinical |  | 18 months | 
| number of complete phenotyping radiological |  | 18 months | 
| number of complete phenotyping biological samples |  | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of lung cancers diagnosed / Number of patients included |  | 18 MONTHS | 
| Number of stage ≤ IIB lung cancers / number of lung cancers diagnosed |  | 18 MONTHS | 
| Number of patients in partial smoking cessation / number of active smoking patients included |  | 18 MONTHS | 
| Satisfaction assessment | by scale SF-12 | 2 times (inclusion, 8 months) | 
| Assessment of ANXIETY | by scale STAI-YA | 2 times (inclusion, 8 months) | 
| Number of initial positive scans / number of initial scans |  | 18 months | 
| Number of invasive procedures resulting in a diagnosis of a benign lesion / number of invasive procedures |  | 18 months | 
| Number of cardiovascular events / number of patients included |  | 18 months | 
| Number of oncological events (other than lung cancer) / number of patients included |  | 18 months |