Atheroma, Chronic Bronchitis, Lung Cancer, Non-progressive Cancer > 5 Years, Smoking-related Pathology
Conditions
Brief summary
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
Interventions
DEVICEthoracic scan Low dose
within 3 months after the V0 visit
BIOLOGICALBLOOD SAMPLE
within 3 months after the V0 visit
BIOLOGICALFECES SAMPLE
within 3 months after the V0 visit
Sponsors
Assistance Publique Hopitaux De Marseille
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction assessment | 2 times (inclusion, 8 months) | by scale SF-12 |
| Assessment of ANXIETY | 2 times (inclusion, 8 months) | by scale STAI-YA |
| Number of initial positive scans / number of initial scans | 18 months | — |
| Number of lung cancers diagnosed / Number of patients included | 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 | — |
| Number of invasive procedures resulting in a diagnosis of a benign lesion / number of invasive procedures | 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 | — |
Countries
France
Outcome results
None listed