Adherence to Lung Cancer Screening by Low-dose Thoracic CT in Haut-Rhin Department, France.

Study Overview
=================
Brief Summary
-----------------
The main objective of the study is to measure adherence to a lung cancer screening program using low-dose thoracic CT.

Detailed Description
-----------------
Secondary objectives To evaluate patient compliance over the entire duration of the screening program To assess patient smoking cessation To describe radiation doses received during CT scans To identify organizational constraints for general practitioners To compare stages at diagnosis before and after implementation of screening program Conduct of research Eligible patients will be identified by general practitioners. Patients included will require a low-dose thoracic CT scan to be performed by a radiologist of their choice. Smoking cessation will be systematically proposed, and will be carried out by the general practitioner or a tobaccologist. The radiation dose from thoracic CT scans should not exceed 100 mGy.cm Product Dose Length (i.e. < 1.5 mSv). Imaging reports will be forwarded to the general practitioner. If the first CT scan is negative (T0): a second scan will be scheduled 1 year later (T1). If this second scan is also negative, in the absence of lung cancer risk factors other than smoking, scans will then be performed every two years. In the presence of a risk factor for lung cancer (other than tobacco), screening will remain annual. In the event of a result classified as uncertain: a follow-up scan is scheduled at 3 months ; if the follow-up scan is negative, the next screening will be scheduled 1 year after this follow-up scan. If the screening performed 1 year later is also negative, subsequent screenings will be performed annually. In the event of a positive result: the general practitioner will refer the patient to a pneumologist of his/her choice for further examinations; data from these additional examinations will be collected. The screening protocol may evolve in line with recommendations issued by the French National Authority for Health (HAS). For participants undergoing CT scan at the imaging department of Emile Muller hospital in Mulhouse (GHRMSA), a blood sample will be collected (optional) for subsequent biomarker assays.

Official Title
-----------------
Adherence to Lung Cancer Screening by Low-dose Thoracic CT in Haut-Rhin Department, France.

Conditions
-----------------
High-Risk Cancer, Lung Cancer

Intervention / Treatment
-----------------
* Procedure: Low Dose chest CT Scan for Lung Cancer Screening


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged 50 to 74 years Smoking OR having smoked (withdrawal of <15 years): ≥15 cigarettes/day for ≥25 years OR ≥10 cigarettes/day for ≥30 years Affiliated or beneficiary of a social security scheme Written informed consent Exclusion Criteria: Inability to walk up two flights of stairs without stopping BMI > 35 kg/m² Recent chest CT scan < 1 year Personal history of lung cancer < 5 years or under treatment Personal history of cancer being monitored by chest CT scan Contraindication to lung cancer treatment or diagnostic investigations Current or recent respiratory symptoms immediately suggestive of lung cancer Pregnant or breast-feeding woman Person under court protection, guardianship or curatorship Person deprived of liberty by judicial or administrative decision.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 74 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: Low Dose chest CT Scan for Lung Cancer Screening
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Patients with a high risk of lung cancer<br> | Procedure: Low Dose chest CT Scan for Lung Cancer Screening<br>* Low dose CT scans will be performed for three years<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of included patients having undergone the first screening scan |  | T0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of patients who refused to participate in the screening program |  | 1 year | 
| Rate of included patients having completed CT scans at each stage of follow-up |  | 3 years | 
| Number of patients newly committed to smoking cessation during the screening period |  | 3 years | 
| Tobacco consumption |  | 3 years | 
| Radiation doses received at each CT scan |  | 3 years | 
| Organizational constraints of the screening program | Organizational constraints of the screening program will be assessed on a subgroup of general practitioners by semi-structured interviews | before starting the study | 
| Stage at diagnosis (TNM classification) of patients with lung cancer | The stages at diagnosis of patients with lung cancer included in the study will be compared with those of undetected patients (data from the Haut-Rhin Cancer Registry). | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
screening, low dose chest computed tomography, lung cancer