Epidemiological Study to Assess the Prevalence of Lung Cancer

NCT03976804 | Unknown

• 1 other identifier: 2019-A00262-55
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer; Tobacco; Atherosclerotic Cardiovascular Event

Keywords

Cancer; Tobacco

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

atherosclerotic cardiovascular event associated with tobacco

EXPERIMENTAL

Other: low dose CT scan; Other: blood sample collection; Other: faecal sample collection

Interventions

low dose CT scan OTHER

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

atherosclerotic cardiovascular event associated with tobacco

blood sample collection OTHER

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

atherosclerotic cardiovascular event associated with tobacco

faecal sample collection OTHER

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

atherosclerotic cardiovascular event associated with tobacco

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 45 - 75 years old
• Patient who has signed an informed written consent
• Daily smoking for at least 10 years
• History of cardiovascular disease:

You may not qualify if:

• 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)

Sponsors & Collaborators

• Centre Chirurgical Marie Lannelongue: lead

Study Sites (1)

Centre Chirurgical Marie Lannelongue

Le Plessis-Robinson, 92350, France

Location

Related Publications (1)

• 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.

  PMID: 36572501 DERIVED

MeSH Terms

Conditions

Lung Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2019
• First Posted: June 6, 2019
• Study Start: November 4, 2019
• Primary Completion: May 4, 2021
• Study Completion: December 2, 2022
• Last Updated: August 9, 2021

Record last verified: 2021-08

Locations

FR (1)