Lung CancerILYADNCT05452200
Lung Cancer Screening Implementation Among Employees at Lyon Hospital
A study testing Solicitation for lung cancer screening and added exams to the usual lung cancer screening in people with Lung Cancer, run by Hospices Civils de Lyon at 3 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Solicitation for lung cancer screening and added exams to the usual lung cancer screening
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 3 sitesFrance
- Study dates
- 21 Sep 2022to 12 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
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- 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.
Who cannot join
- 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:
Show all 15Show fewer
- 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.
Trial locations and contacts
3 sites in 1 country.
France3 sites, 3 recruiting
- Recruiting
Hôpital L. Pradel
Bron
Michael DURUISSEAUX, MD
- Recruiting
Hôpital de la Croix Rousse - Department of Pneumology
Lyon
Lize KIAKOUAMA-MALEKA, MD, 0426109237 ext. +33, lize.kiakouama-maleka@chu-lyon.fr
Lize KIAKOUAMA-MALEKA, MD
- Recruiting
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495
Sébastien COURAUD, PhD, 0478863718 ext. +33, sebastien.couraud@chu-lyon.fr
About this study
Official title: 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.
Read more
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.
- Conditions
- Lung Cancer
- Being tested
- Solicitation for lung cancer screening, added exams to the usual lung cancer screening
- Keywords
- lung cancer, screening, tobacco cessation, COPD
- Medical subject headings
- Lung Neoplasms, Tobacco Use Cessation, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Solicitation for lung cancer screeningBehavioural
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
added exams to the usual lung cancer screeningOther
- spirometry examination
- Questionnaires
- Blood samples and breath samples to find biomarkers
| Study group | Role | What they receive |
|---|---|---|
| Lyon hospital employees with high risk of lung cancer. | Experimental | Lyon Hospital employees meeting criteria for high risk of lung cancer according French recommendation criteria. Receives: Behavioral: Solicitation for lung cancer screening; Other: added exams to the usual lung cancer screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participation rate at baseline
Ratio between the number of participants who underwent a CT scan at baseline and the estimated number of eligible employees
Measured: At the baseline visit
Secondary outcomes (8)
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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Follow up after the 1 year visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2022
- Study start21 Sep 2022
- Primary completion12 Sep 2024 (estimated)
- Study completion12 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05452200
- Sponsor's protocol ID
- 69HCL22_0466
- Acronym
- ILYAD
- Status last verified
- Sep 2023
- First submitted
- 5 Jul 2022
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study on Lung Cancer Screening Implementation Among Employees at Lyon Hospital
- ClinicalTrials.gov ID
- NCT05452200
- Acronym / sponsor ID
- ILYAD / 69HCL22_0466
- Conditions
- Lung Cancer
- Keywords
- lung cancer, screening, tobacco cessation, COPD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 21 Sep 2022 (actual)
- Primary completion
- 12 Sep 2024 (estimated)
- Study completion
- 12 Sep 2024 (estimated)
- First posted
- 11 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lyon hospital employees with high risk of lung cancer. | Experimental | Behavioral: Solicitation for lung cancer screening, Other: added exams to the usual lung cancer screeningLyon Hospital employees meeting criteria for high risk of lung cancer according French recommendation criteria. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- valid hospital employee number,
- Or retired employee for less than a year before the inclusion
- 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 ;
Key exclusion criteria (15 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Solicitation for lung cancer screening3 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 | Behavioural | Lyon hospital employees with high risk of lung cancer. |
| added exams to the usual lung cancer screening* spirometry examination * Questionnaires * Blood samples and breath samples to find biomarkers | Other | Lyon hospital employees with high risk of lung cancer. |
Primary outcome
Participation rate at baseline
Time frame: At the baseline visit
Ratio between the number of participants who underwent a CT scan at baseline and the estimated number of eligible employees
8 secondary outcomes
Participation rate according to the 3 communication levels.
Time frame: At 4 month = level 1 ; At 8 month = level 2 ; At 12 month = level 3
Identification of predictive factors for participation decision
Time frame: 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.
Time frame: 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.
Time frame: At baseline and At 1Year follow-up
Evaluate the participation rate at 1 year and identify the factors that trigger it.
Time frame: At 1Year follow-up
Identification of efficient biomarker for LC screening
Time frame: At baseline
Evaluation of the efficiency of VOC for LC screening
Time frame: At baseline
Evaluate the follow up to the french guidelines
Time frame: Follow up after the 1 year visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Solicitation for lung cancer screening and added exams to the usual lung cancer screening in people with Lung Cancer, run by Hospices Civils de Lyon at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sébastien COURAUD, Pr (04.78.86.44.01, sebastien.couraud@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participation rate at baseline (time frame: At the baseline visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.