Epidemiological Study to Assess the Prevalence of Lung Cancer

Not Applicable

• Conditions: Lung Cancer; Tobacco; Atherosclerotic Cardiovascular Event
• Interventions: Other: low dose CT scan; Other: blood sample collection; Other: faecal sample collection

• Registration Number: NCT03976804
• Lead Sponsor: Centre Chirurgical Marie Lannelongue

Brief Summary

Lung cancer is the main cause of mortality by cancer in France. The lung cancer stage at time of diagnosis is a major determinant of survival. To date, 75% of lung cancer are diagnosed at an advanced stage with worse survival). Lung cancer screening is based on low dose CT scan which allows to decrease lung cancer related mortality of 20% in patients aged 55-74 years-old with a history of tobacco consumption ≥ 30 PY active of who quite \< 15 years. These criteria for eligibility for lung cancer screening lead to 1 to 2% of lung cancer diagnosis at the first CT scan. In our experience regarding 1 year of lung cancer surgical resection, only 45% of the patients presented criteria for lung cancer screening. Moreover, the duration of tobacco consumption would provide a better stratification of lung cancer risk compared to only PY. Therefore, other criteria for lung cancer screening eligibility could be proposed. Currently, 9 out of 10 lung cancer is linked with tobacco consumption which is also a major risk factor for atherosclerosis-associated cardiovascular events. Around 40% of patients with a lung cancer have a history of atherosclerosis-associated cardiovascular event, mainly coronary artery diseases and peripheral artery diseases. Main Objective: The objective is to compare the observed rate of lung cancer prevalence in our study to the rate of around 2 % observed in lung cancer screening trials in south Europe (France and Italy).

The investigators hypothesize that the population of patients with a history of atherosclerotic cardiovascular event associated with tobacco consumption present a higher prevalence of lung cancer compared with the population of patients eligible for lung cancer screening program which is defined by age and history of tobacco consumption.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-06-03
• Study First Submitted QC: 2019-06-05
• Study First Posted: 2019-06-06
• Study Start: 2019-11-04
• Primary Completion: 2021-05-04
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-06
• Last Update Posted: 2021-08-09
• Study Completion: 2022-12-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Age 45 - 75 years old
• Patient who has signed an informed written consent
• Daily smoking for at least 10 years
• History of cardiovascular disease:

Exclusion Criteria

• History of active cancer < 5 years (except in situ cervical carcinoma and basal cell carcinoma of the skin)
• Lung cancer symptoms (involuntary weight loss > 6.8 kg in 1 year, hemoptysis)
• Treatment or bleeding risk syndrome contraindicating an invasive diagnostic procedure within 3 months.
• Active pulmonary parenchymal infection
• Severe cardiac or respiratory insufficiency (resting dyspnea)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
atherosclerotic cardiovascular event associated with tobacco	blood sample collection	-
atherosclerotic cardiovascular event associated with tobacco	low dose CT scan	-
atherosclerotic cardiovascular event associated with tobacco	faecal sample collection	-

Primary Outcome Measures

Name	Time	Method
prevalence of lung cancer	19 months	estimation of the prevalence of lung cancer among patients managed for atherosclerosis-related cardiovascular events associated with tobacco consumption.

Trial Locations

Locations (1)

Centre Chirurgical Marie Lannelongue; 🇫🇷 Le Plessis-Robinson, France