Epidemiological Study to Assess the Prevalence of Lung Cancer (PREVALUNG)
Primary Purpose
Lung Cancer, Tobacco, Atherosclerotic Cardiovascular Event
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
low dose CT scan
blood sample collection
faecal sample collection
Sponsored by
About this trial
This is an interventional health services research trial for Lung Cancer focused on measuring Cancer, Tobacco
Eligibility Criteria
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)
Sites / Locations
- Centre Chirurgical Marie Lannelongue
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
atherosclerotic cardiovascular event associated with tobacco
Arm Description
Outcomes
Primary Outcome Measures
prevalence of lung cancer
estimation of the prevalence of lung cancer among patients managed for atherosclerosis-related cardiovascular events associated with tobacco consumption.
Secondary Outcome Measures
Full Information
NCT ID
NCT03976804
First Posted
June 3, 2019
Last Updated
August 6, 2021
Sponsor
Centre Chirurgical Marie Lannelongue
1. Study Identification
Unique Protocol Identification Number
NCT03976804
Brief Title
Epidemiological Study to Assess the Prevalence of Lung Cancer
Acronym
PREVALUNG
Official Title
Epidemiological Study to Assess the Prevalence of Lung Cancer in Patients With Smocking-associated Atherosclerotic Cardiovascular Diseases
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 4, 2019 (Actual)
Primary Completion Date
May 4, 2021 (Actual)
Study Completion Date
December 2, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Chirurgical Marie Lannelongue
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Tobacco, Atherosclerotic Cardiovascular Event
Keywords
Cancer, Tobacco
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
atherosclerotic cardiovascular event associated with tobacco
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
low dose CT scan
Intervention Description
Lung cancer screening will be based on the analysis of a low dose CT scan
Intervention Type
Other
Intervention Name(s)
blood sample collection
Intervention Description
establish a phenotyping of immunity, blood inflammation and digestive and tumour microbiota
Intervention Type
Other
Intervention Name(s)
faecal sample collection
Intervention Description
establish a phenotyping of immunity, blood inflammation and digestive and tumour microbiota
Primary Outcome Measure Information:
Title
prevalence of lung cancer
Description
estimation of the prevalence of lung cancer among patients managed for atherosclerosis-related cardiovascular events associated with tobacco consumption.
Time Frame
19 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Centre Chirurgical Marie Lannelongue
City
Le Plessis-Robinson
ZIP/Postal Code
92350
Country
France
12. IPD Sharing Statement
Learn more about this trial
Epidemiological Study to Assess the Prevalence of Lung Cancer
We'll reach out to this number within 24 hrs