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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03976804
Other study ID # 2019-A00262-55
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date November 4, 2019
Est. completion date December 2, 2022

Study information

Verified date August 2021
Source Centre Chirurgical Marie Lannelongue
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 500
Est. completion date December 2, 2022
Est. primary completion date May 4, 2021
Accepts healthy volunteers No
Gender All
Age group 45 Years to 75 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Other:
low dose CT scan
Lung cancer screening will be based on the analysis of a low dose CT scan
blood sample collection
establish a phenotyping of immunity, blood inflammation and digestive and tumour microbiota
faecal sample collection
establish a phenotyping of immunity, blood inflammation and digestive and tumour microbiota

Locations

Country Name City State
France Centre Chirurgical Marie Lannelongue Le Plessis-Robinson

Sponsors (1)

Lead Sponsor Collaborator
Centre Chirurgical Marie Lannelongue

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary prevalence of lung cancer estimation of the prevalence of lung cancer among patients managed for atherosclerosis-related cardiovascular events associated with tobacco consumption. 19 months
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