Epidemiological Study to Assess the Prevalence of Lung Cancer

NCT ID: NCT03976804

Last Updated: 2021-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-04

Study Completion Date

2022-12-02

Brief Summary

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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

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Conditions

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Lung Cancer Tobacco Atherosclerotic Cardiovascular Event

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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atherosclerotic cardiovascular event associated with tobacco

Group Type EXPERIMENTAL

low dose CT scan

Intervention Type OTHER

Lung cancer screening will be based on the analysis of a low dose CT scan

blood sample collection

Intervention Type OTHER

establish a phenotyping of immunity, blood inflammation and digestive and tumour microbiota

faecal sample collection

Intervention Type OTHER

establish a phenotyping of immunity, blood inflammation and digestive and tumour microbiota

Interventions

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low dose CT scan

Lung cancer screening will be based on the analysis of a low dose CT scan

Intervention Type OTHER

blood sample collection

establish a phenotyping of immunity, blood inflammation and digestive and tumour microbiota

Intervention Type OTHER

faecal sample collection

establish a phenotyping of immunity, blood inflammation and digestive and tumour microbiota

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Chirurgical Marie Lannelongue

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Centre Chirurgical Marie Lannelongue

Le Plessis-Robinson, , France

Site Status

Countries

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France

References

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Boulate D, Fidelle M, Caramella C, Issard J, Planche O, Pradere P, Garelik D, Hache O, Lamrani L, Zins M, Beaussier H, Chatellier G, Fadel E, Zitvogel L, Besse B, Mercier O. Epidemiological Study to Assess the Prevalence of Lung Cancer in patients with smoking-associated atherosclerotic cardiovascular diseases: PREVALUNG study protocol. BMJ Open. 2022 Dec 26;12(12):e067191. doi: 10.1136/bmjopen-2022-067191.

Reference Type DERIVED
PMID: 36572501 (View on PubMed)

Other Identifiers

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2019-A00262-55

Identifier Type: -

Identifier Source: org_study_id

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