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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06020443
Other study ID # GHR 1303
Secondary ID 2023-A00803-42
Status Recruiting
Phase N/A
First received
Last updated
Start date November 6, 2023
Est. completion date November 2026

Study information

Verified date November 2023
Source Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
Contact Didier Debieuvre, MD
Phone +33389647032
Email debieuvred@ghrmsa.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 126
Est. completion date November 2026
Est. primary completion date November 2024
Accepts healthy volunteers No
Gender All
Age group 50 Years to 74 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Low Dose chest CT Scan for Lung Cancer Screening
Low dose CT scans will be performed for three years

Locations

Country Name City State
France Cabinet de médecine générale Colmar Haut-Rhin

Sponsors (1)

Lead Sponsor Collaborator
Groupe Hospitalier de la Region de Mulhouse et Sud Alsace

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rate of included patients having undergone the first screening scan T0
Secondary Rate of patients who refused to participate in the screening program 1 year
Secondary Rate of included patients having completed CT scans at each stage of follow-up 3 years
Secondary Number of patients newly committed to smoking cessation during the screening period 3 years
Secondary Tobacco consumption 3 years
Secondary Radiation doses received at each CT scan 3 years
Secondary 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
Secondary 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
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