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

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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

Tracking Information
First Submitted Date January 22, 2020
First Posted Date January 27, 2020
Last Update Posted Date January 27, 2020
Estimated Study Start Date March 2020
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 22, 2020)
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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Initiative in LYon for Lung cAncer Screening Development - Prevalence Study
Official Title Initiative in LYon for Lung cAncer Screening Development - Prevalence Study
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Ecologic or Community
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population The Civil Hospices of Lyon is the second largest university hospital in France, with 23000 staff.
Condition
  • Lung Cancer
  • Screening
Intervention 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.
Study Groups/Cohorts Lyon University Hospital employees
Intervention: Other: Survey
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 Not yet recruiting
Estimated Enrollment
 (submitted: January 22, 2020)
23000
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 2020
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
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
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT04240418
Other Study ID Numbers ILYAD1_2019
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 Not Provided
Responsible Party Hospices Civils de Lyon
Study Sponsor Hospices Civils de Lyon
Collaborators Not Provided
Investigators Not Provided
PRS Account Hospices Civils de Lyon
Verification Date January 2020