Lung Cancer Screening Implementation Among Employees at Lyon Hospital (ILYAD)

Pilot Study on Lung Cancer Screening Implementation Among Employees at Lyon Hospital

Several randomized studies have demonstrated the efficiency of lung cancer screening (LCS) on mortality rates. However, screening efficiency is related to the targeted population and the participation rate.

In France, the participation rate for breast and colon cancer screening programs is respectively 50% and 32%, which is low. Then, it appears very important to determine which factors are influencing the willingness to participate to these programs. Indeed, it will allow a better communication and we will be able to perform screening campaigns adapted to the eligible population.

The Lyon Hospital is the second university hospital in France. It is composed of 14 buildings and employed 23 000 persons. More than 160 occupations are represented. So, hospital employees look relevant to be studied for LCS program.

ILYAD was divided in 2 parts. The first one was completed in 2020 and goal to evaluate the number of eligible individuals among the hospital employees. About 800 persons would be eligible for LCS.

This second part of the study will evaluate the participation rate and the feasibility of the LCS program. The study will target the 800 individuals that were identified previously.

Study Overview

• Status: Recruiting
• Conditions: Lung Cancer
• Intervention / Treatment: Behavioral: Solicitation for lung cancer screening; Other: added exams to the usual lung cancer screening

• Study Type: Interventional
• Enrollment (Estimated): 600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sébastien COURAUD, Pr; Phone Number: 04.78.86.44.01; Email: sebastien.couraud@chu-lyon.fr
• Study Contact Backup: Name: Julie DE BERMONT; Phone Number: +33 0478866698; Email: Julie.de-bermont@chu-lyon.fr

Study Locations

• France
  • Bron, France
    • Recruiting
    • Hôpital L. Pradel
    • Contact: Michael Duruisseaux, MD
  • Lyon, France
    • Recruiting
    • Hôpital de la Croix Rousse - Department of Pneumology
    • Contact: Lize KIAKOUAMA-MALEKA, MD; Phone Number: +33 0426109237; Email: lize.kiakouama-maleka@chu-lyon.fr
    • Principal Investigator: Lize KIAKOUAMA-MALEKA, MD
  • Pierre-Bénite, France, 69495
    • Recruiting
    • Centre Hospitalier Lyon Sud
    • Contact: Sébastien COURAUD, PhD; Phone Number: +33 0478863718; Email: sebastien.couraud@chu-lyon.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

• Inclusion Criteria :

  • Participant have to meet the criteria below:

Lyon hospital employee at the day of inclusion:

• valid hospital employee number,
• Or retired employee for less than a year before the inclusion

AND meeting eligibility criteria as follow :

• Aged from 50 to 75 yo,
• AND smoke or have smoked ≥ 10 cigarettes/day during ≥ 30 years OR ≥ 15 cigarettes/day for at least 25 years;

• AND active smoker or smoking cessation for ≤ 15 years ;

  • Volunteer to start a program of smoking cessation if active smoker;
  • Consent form signed ;

  • Cover by health insurance.

    • Exclusion Criteria :

Participant have to NOT meet the criteria below :

• Individual not working at Lyon hospital;
• Individual not payed by the Lyon Hospital but working at it;
• Individuals not willing to participate;
• Individual working at René Sabran Hospital;

• Individual meeting one of this non eligibility for LCS criteria defined by the French recommendation:

  • Not able to climb 2 floors of stairs ;
  • Weight ≥ 140Kg
  • Underwent a chest CT scan less than 1 year ago (except screening scanner);
  • History of lung cancer of less than 5 years or under treatment ; history of any cancer under monitoring by chest scanner ;
  • Comorbidity contraindicating therapeutic options or any kind of invasive interventions ;
  • Ongoing or recent respiratory symptoms that might lead to lung cancer diagnosis (hemoptysia, weight loss, recurrent respiratory infection).
• Individual who is pregnant or breast feeding;
• Individual whose mental health is not good enough to participate;
• Individual in jail or under justice evaluation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Lyon hospital employees with high risk of lung cancer.; Lyon Hospital employees meeting criteria for high risk of lung cancer according French recommendation criteria.

Behavioral: Solicitation for lung cancer screening; 3 levels of solicitation will be cumulated. First : a Simple collective solicitation of all staff via internal media 4 months later : Personalized indirect solicitation of at-risk groups with information posted in identified areas 4 months later : Personalized direct solicitation of at-risk groups; Other: added exams to the usual lung cancer screening; spirometry examination; Questionnaires; Blood samples and breath samples to find biomarkers

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participation rate at baseline	Ratio between the number of participants who underwent a CT scan at baseline and the estimated number of eligible employees	At the baseline visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participation rate according to the 3 communication levels.	Ratio between the number of participants who underwent the baseline CT scan at level 1, 2 and 3 and the estimated number of eligible employees	At 4 month = level 1 ; At 8 month = level 2 ; At 12 month = level 3
Identification of predictive factors for participation decision	Using the cox model to identify sociodemographic factors that could be associated with the participation rates for both round of CT scan.	At baseline and At 1Year follow-up
Evaluation of feasibility of the LCS program by measuring the proportion of individuals having undergo all the required exams and evaluations according to the results of the CT scan, conformity of the scan interpretation, and adverse event monitoring.	Ratio between individuals who completed baseline and year 1 CT scan and the number of participants. And, the ratio of individuals who beneficiated conform care according to French recommendations.	At baseline and At 1Year follow-up
Evaluation of screening efficiency according to the proportion of lung cancer, ILD, COPD diagnosed and the percentage of smoking cessation among the active smokers.	Ratio of lung cancer diagnosed Ration of ILD diagnosed Ratio of COPD diagnosed Ratio of smoking cessation	At baseline and At 1Year follow-up
Evaluate the participation rate at 1 year and identify the factors that trigger it.	Ratio between the number of participants who underwent the Year 1 CT scan and the number of participants.	At 1Year follow-up
Identification of efficient biomarker for LC screening	Perform blood analysis to identify specific biomarkers and compare their sensibility, and predictive value with or without association with the CT scan.	At baseline
Evaluation of the efficiency of VOC for LC screening	Perform air breath analysis to identify specific chemical species, compare their sensibility, and predictive value associated, and not with the CT scan.	At baseline
Evaluate the follow up to the french guidelines	Ratio between the participant at the cohort and who have done the scanner 2 years post Year1 one, and the participant at the cohort.	Follow up after the 1 year visit

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2022
• Primary Completion (Estimated): September 12, 2024
• Study Completion (Estimated): September 12, 2024

Study Registration Dates

• First Submitted: July 5, 2022
• First Submitted That Met QC Criteria: July 8, 2022
• First Posted (Actual): July 11, 2022

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 26, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: COPD; lung cancer; screening; tobacco cessation
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: 69HCL22_0466

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No