4006-776-356 出国就医服务电话

免费获得国外相关药品,最快 1 个工作日回馈药物信息

出境医 / 临床实验 / Epidemiological Study to Assess the Prevalence of Lung Cancer (PREVALUNG)

Epidemiological Study to Assess the Prevalence of Lung Cancer (PREVALUNG)

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.


Condition or disease Intervention/treatment Phase
Lung Cancer Tobacco Atherosclerotic Cardiovascular Event Other: low dose CT scan Other: blood sample collection Other: faecal sample collection Not Applicable

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Epidemiological Study to Assess the Prevalence of Lung Cancer in Patients With Smocking-associated Atherosclerotic Cardiovascular Diseases
Actual Study Start Date : November 4, 2019
Estimated Primary Completion Date : April 2, 2021
Estimated Study Completion Date : May 2, 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: atherosclerotic cardiovascular event associated with tobacco Other: low dose CT scan
Lung cancer screening will be based on the analysis of a low dose CT scan

Other: blood sample collection
establish a phenotyping of immunity, blood inflammation and digestive and tumour microbiota

Other: faecal sample collection
establish a phenotyping of immunity, blood inflammation and digestive and tumour microbiota

Outcome Measures
Primary Outcome Measures :
  1. prevalence of lung cancer [ Time Frame: 19 months ]
    estimation of the prevalence of lung cancer among patients managed for atherosclerosis-related cardiovascular events associated with tobacco consumption.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations

Locations
Layout table for location information
France
Centre Chirurgical Marie Lannelongue Recruiting
Le Plessis-Robinson, France, 92350
Contact: David BOULATE, MD    01.40.94.87.25    d.boulate@hml.fr   
Sponsors and Collaborators
Centre Chirurgical Marie Lannelongue
Tracking Information
First Submitted Date  ICMJE June 3, 2019
First Posted Date  ICMJE June 6, 2019
Last Update Posted Date January 23, 2020
Actual Study Start Date  ICMJE November 4, 2019
Estimated Primary Completion Date April 2, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 5, 2019)
prevalence of lung cancer [ Time Frame: 19 months ]
estimation of the prevalence of lung cancer among patients managed for atherosclerosis-related cardiovascular events associated with tobacco consumption.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Epidemiological Study to Assess the Prevalence of Lung Cancer
Official Title  ICMJE Epidemiological Study to Assess the Prevalence of Lung Cancer in Patients With Smocking-associated Atherosclerotic Cardiovascular Diseases
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Lung Cancer
  • Tobacco
  • Atherosclerotic Cardiovascular Event
Intervention  ICMJE
  • Other: low dose CT scan
    Lung cancer screening will be based on the analysis of a low dose CT scan
  • Other: blood sample collection
    establish a phenotyping of immunity, blood inflammation and digestive and tumour microbiota
  • Other: faecal sample collection
    establish a phenotyping of immunity, blood inflammation and digestive and tumour microbiota
Study Arms  ICMJE Experimental: atherosclerotic cardiovascular event associated with tobacco
Interventions:
  • Other: low dose CT scan
  • Other: blood sample collection
  • Other: faecal sample collection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 5, 2019)
500
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2, 2021
Estimated Primary Completion Date April 2, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03976804
Other Study ID Numbers  ICMJE 2019-A00262-55
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Centre Chirurgical Marie Lannelongue
Study Sponsor  ICMJE Centre Chirurgical Marie Lannelongue
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Centre Chirurgical Marie Lannelongue
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

治疗医院