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Initiative in LYon for Lung cAncer Screening Development - Prevalence Study (ILYAD1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04240418
Recruitment Status : Not yet recruiting
First Posted : January 27, 2020
Last Update Posted : January 27, 2020
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief Summary:

Screening at-risk subjects with low-dose computed tomography (CT) efficiently reduces lung cancer specific mortality. However screening efficiency relies on the at-risk population's criteria definition and its participation rate to the screening. In France, there are concerns regarding the participation rates to national cancer screening that are quite low (around 50% and 32% of the eligible population for breast cancer and colorectal cancer respectively). Before organizing national lung cancer screening it is then crucial to determine the factors impacting the at-risk subjects willingness to participate in lung cancer screening.

The Lyon University Hospital is the second biggest hospital in France with more than 23,000 employees distributed among more than 160 professions representing every level of education or working conditions. Its population is heterogeneous and wide enough to perform a prevalence study assessing the willingness to participate among the at-risk population.

ILYAD is a prospective study performed by anonymous questionnaires that will be submitted to the 23,000 employees of the Lyon University Hospital. The study main objective is to evaluate the at-risk population presence in the Lyon University Hospital population, as defined by NELSON criteria and selection criteria for lung cancer screening (PLCOm2012 scoring), and its willingness to participate to a lung-cancer screening with low-dose CT. This might help further efficient national lung cancer screening campaign organization.


Condition or disease Intervention/treatment
Lung Cancer Screening Other: Survey

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Study Type : Observational
Estimated Enrollment : 23000 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Initiative in LYon for Lung cAncer Screening Development - Prevalence Study
Estimated Study Start Date : March 2020
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Lyon University Hospital employees Other: Survey
The objective is to evaluate the eligibility of the responders, as defined by NELSON criteria and PLCOm2012 scoring, and their willingness to participate to a lung-cancer screening with low-dose computed tomography.




Primary Outcome Measures :
  1. Number of employees belonging to the at-risk population for lung cancer and consequently eligible to lung cancer screening. [ Time Frame: Day 0 (at inclusion) ]
    High-risk ever-smokers are defined as ever-smokers aged 55-74 years old, having smoked >15 cigarettes per day for >25 years or >10 cigarettes for >30 years and with ≤15 years since cessation for quitters.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The Civil Hospices of Lyon is the second largest university hospital in France, with 23000 staff.
Criteria

Inclusion Criteria:

  • Aged ≥ 18 years old
  • Employee from the Lyon University Hospital (receiving salary from the Lyon University Hospital)
  • Person who has willingness to respond the survey

Exclusion Criteria:

  • Employees not hired by the Lyon University Hospital
  • Employees who have not willingness to participate in the survey

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04240418


Contacts
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Contact: Sebastien COURAUD, MD 4 78 86 44 01 ext +33 sebastien.couraud@chu-lyon.fr
Contact: Flavien DEVUN, PHARM 4 78 86 44 01 ext +33 flavien.devun@chu-lyon.fr

Locations
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France
Hospices Civils de Lyon
Lyon, France, 69000
Contact: Sebastien COURAUD, MD    4 78 86 44 01 ext +33    sebastien.couraud@chu-lyon.fr   
Contact: Flavien DEVUN, PHARM    4 78 86 44 01 ext +33    flavien.devun@chu-lyon.fr   
Principal Investigator: Sebastien COURAUD, MD         
Sponsors and Collaborators
Hospices Civils de Lyon
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT04240418    
Other Study ID Numbers: ILYAD1_2019
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases