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

July 12, 2021 updated by: Hospices Civils de Lyon

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

4595

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Lyon, France, 69000
        • Hospices Civils de Lyon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The Civil Hospices of Lyon is the second largest university hospital in France, with 23000 staff.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Ecologic or Community
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Lyon University Hospital employees
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 0 (at inclusion)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 31, 2020

Primary Completion (Actual)

January 14, 2021

Study Completion (Actual)

January 14, 2021

Study Registration Dates

First Submitted

January 22, 2020

First Submitted That Met QC Criteria

January 22, 2020

First Posted (Actual)

January 27, 2020

Study Record Updates

Last Update Posted (Actual)

July 13, 2021

Last Update Submitted That Met QC Criteria

July 12, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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