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

Primary Purpose

Lung Cancer

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Solicitation for lung cancer screening
added exams to the usual lung cancer screening
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lung Cancer focused on measuring lung cancer, screening, tobacco cessation, COPD

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers
  • 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.

Sites / Locations

  • Hôpital L. PradelRecruiting
  • Hôpital de la Croix Rousse - Department of PneumologyRecruiting
  • Centre Hospitalier Lyon SudRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lyon hospital employees with high risk of lung cancer.

Arm Description

Lyon Hospital employees meeting criteria for high risk of lung cancer according French recommendation criteria.

Outcomes

Primary Outcome Measures

Participation rate at baseline
Ratio between the number of participants who underwent a CT scan at baseline and the estimated number of eligible employees

Secondary Outcome Measures

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
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.
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.
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
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.
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.
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.
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.

Full Information

First Posted
July 5, 2022
Last Updated
September 26, 2023
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT05452200
Brief Title
Lung Cancer Screening Implementation Among Employees at Lyon Hospital
Acronym
ILYAD
Official Title
Pilot Study on Lung Cancer Screening Implementation Among Employees at Lyon Hospital
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 21, 2022 (Actual)
Primary Completion Date
September 12, 2024 (Anticipated)
Study Completion Date
September 12, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
lung cancer, screening, tobacco cessation, COPD

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lyon hospital employees with high risk of lung cancer.
Arm Type
Experimental
Arm Description
Lyon Hospital employees meeting criteria for high risk of lung cancer according French recommendation criteria.
Intervention Type
Behavioral
Intervention Name(s)
Solicitation for lung cancer screening
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
added exams to the usual lung cancer screening
Intervention Description
spirometry examination Questionnaires Blood samples and breath samples to find biomarkers
Primary Outcome Measure Information:
Title
Participation rate at baseline
Description
Ratio between the number of participants who underwent a CT scan at baseline and the estimated number of eligible employees
Time Frame
At the baseline visit
Secondary Outcome Measure Information:
Title
Participation rate according to the 3 communication levels.
Description
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
Time Frame
At 4 month = level 1 ; At 8 month = level 2 ; At 12 month = level 3
Title
Identification of predictive factors for participation decision
Description
Using the cox model to identify sociodemographic factors that could be associated with the participation rates for both round of CT scan.
Time Frame
At baseline and At 1Year follow-up
Title
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.
Description
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.
Time Frame
At baseline and At 1Year follow-up
Title
Evaluation of screening efficiency according to the proportion of lung cancer, ILD, COPD diagnosed and the percentage of smoking cessation among the active smokers.
Description
Ratio of lung cancer diagnosed Ration of ILD diagnosed Ratio of COPD diagnosed Ratio of smoking cessation
Time Frame
At baseline and At 1Year follow-up
Title
Evaluate the participation rate at 1 year and identify the factors that trigger it.
Description
Ratio between the number of participants who underwent the Year 1 CT scan and the number of participants.
Time Frame
At 1Year follow-up
Title
Identification of efficient biomarker for LC screening
Description
Perform blood analysis to identify specific biomarkers and compare their sensibility, and predictive value with or without association with the CT scan.
Time Frame
At baseline
Title
Evaluation of the efficiency of VOC for LC screening
Description
Perform air breath analysis to identify specific chemical species, compare their sensibility, and predictive value associated, and not with the CT scan.
Time Frame
At baseline
Title
Evaluate the follow up to the french guidelines
Description
Ratio between the participant at the cohort and who have done the scanner 2 years post Year1 one, and the participant at the cohort.
Time Frame
Follow up after the 1 year visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sébastien COURAUD, Pr
Phone
04.78.86.44.01
Email
sebastien.couraud@chu-lyon.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Julie DE BERMONT
Phone
+33 0478866698
Email
Julie.de-bermont@chu-lyon.fr
Facility Information:
Facility Name
Hôpital L. Pradel
City
Bron
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael DURUISSEAUX, MD
Facility Name
Hôpital de la Croix Rousse - Department of Pneumology
City
Lyon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lize KIAKOUAMA-MALEKA, MD
Phone
0426109237
Ext
+33
Email
lize.kiakouama-maleka@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Lize KIAKOUAMA-MALEKA, MD
Facility Name
Centre Hospitalier Lyon Sud
City
Pierre-Bénite
ZIP/Postal Code
69495
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sébastien COURAUD, PhD
Phone
0478863718
Ext
+33
Email
sebastien.couraud@chu-lyon.fr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Lung Cancer Screening Implementation Among Employees at Lyon Hospital

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