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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
Centre Chirurgical Marie Lannelongue
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Lung Cancer focused on measuring Cancer, Tobacco

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
June 3, 2019
Last Updated
August 6, 2021
Sponsor
Centre Chirurgical Marie Lannelongue
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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

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