Lung Cancer Screening Implementation Among Employees at Lyon Hospital

Not Applicable

Recruiting

• Conditions: Lung Cancer
• Interventions: Behavioral: Solicitation for lung cancer screening; Other: added exams to the usual lung cancer screening

• Registration Number: NCT05452200
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2022-07-05
• Study First Submitted QC: 2022-07-08
• Study First Posted: 2022-07-11
• Study Start: 2022-09-21
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-26
• Last Update Posted: 2023-09-28
• Primary Completion: 2024-09-12
• Study Completion: 2024-09-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lyon hospital employees with high risk of lung cancer.	added exams to the usual lung cancer screening	Lyon Hospital employees meeting criteria for high risk of lung cancer according French recommendation criteria.
Lyon hospital employees with high risk of lung cancer.	Solicitation for lung cancer screening	Lyon Hospital employees meeting criteria for high risk of lung cancer according French recommendation criteria.

Primary Outcome Measures

Name	Time	Method
Participation rate at baseline	At the baseline visit	Ratio between the number of participants who underwent a CT scan at baseline and the estimated number of eligible employees

Secondary Outcome Measures

Name	Time	Method
Evaluate the participation rate at 1 year and identify the factors that trigger it.	At 1Year follow-up	Ratio between the number of participants who underwent the Year 1 CT scan and the number of participants.
Evaluation of the efficiency of VOC for LC screening	At baseline	Perform air breath analysis to identify specific chemical species, compare their sensibility, and predictive value associated, and not with the CT scan.
Participation rate according to the 3 communication levels.	At 4 month = level 1 ; At 8 month = level 2 ; At 12 month = level 3	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
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.	At baseline and At 1Year follow-up	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.
Identification of efficient biomarker for LC screening	At baseline	Perform blood analysis to identify specific biomarkers and compare their sensibility, and predictive value with or without association with the CT scan.
Identification of predictive factors for participation decision	At baseline and At 1Year follow-up	Using the cox model to identify sociodemographic factors that could be associated with the participation rates for both round of CT scan.
Evaluation of screening efficiency according to the proportion of lung cancer, ILD, COPD diagnosed and the percentage of smoking cessation among the active smokers.	At baseline and At 1Year follow-up	Ratio of lung cancer diagnosed Ration of ILD diagnosed Ratio of COPD diagnosed Ratio of smoking cessation
Evaluate the follow up to the french guidelines	Follow up after the 1 year visit	Ratio between the participant at the cohort and who have done the scanner 2 years post Year1 one, and the participant at the cohort.

Trial Locations

Locations (3)

Hôpital L. Pradel; 🇫🇷 Bron, France

Hôpital de la Croix Rousse - Department of Pneumology; 🇫🇷 Lyon, France

Centre Hospitalier Lyon Sud; 🇫🇷 Pierre-Bénite, France