Epidemiological Study to Assess the Prevalence of Lung Cancer

Lung Cancer Clinical Trial

— PREVALUNG  

Official title:

Epidemiological Study to Assess the Prevalence of Lung Cancer in Patients With Smocking-associated Atherosclerotic Cardiovascular Diseases

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03976804
• Other study ID #: 2019-A00262-55
• Status: Active, not recruiting
• Phase: N/A
• 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
• 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)

Related Conditions & MeSH terms

• Atherosclerotic Cardiovascular Event
• Lung Cancer
• Lung Neoplasms
• Tobacco

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