NCT06020443

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 126 (estimated)
• Sponsor: Groupe Hospitalier de la Region de Mulhouse et Sud Alsace · Academic / Other
• Sex: All
• Age: 50 Years – 74 Years
• Healthy volunteers: Not accepted

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 1. To evaluate patient compliance over the entire duration of the screening program 2. To assess patient smoking cessation 3. To describe radiation doses received during CT scans 4. To identify organizational constraints for general practitioners 5. 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.

Conditions

• High-Risk Cancer
• Lung Cancer

Interventions

Type	Name	Description
PROCEDURE	Low Dose chest CT Scan for Lung Cancer Screening	Low dose CT scans will be performed for three years

Timeline

• Start date: 2023-11-06
• Primary completion: 2024-11-05
• Completion: 2026-11-01
• First posted: 2023-08-31
• Last updated: 2025-05-16

Locations

1 site across 1 country: France