Lung CancerILYAD1NCT04240418
Initiative in LYon for Lung cAncer Screening Development - Prevalence Study
An observational study of Lung Cancer and Screening, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer, Screening
- What is being tested?
- Survey
- How many people
- 4,595 participants
- Where
- 1 siteFrance
- Study dates
- 31 Oct 2020to 14 Jan 2021
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The Civil Hospices of Lyon is the second largest university hospital in France, with 23000 staff.
Who may be able to join
- 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
Who cannot join
- Employees not hired by the Lyon University Hospital
- Employees who have not willingness to participate in the survey
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Lung Cancer, Screening
- Being tested
- Survey
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Lyon University Hospital employees | Not described Receives: Other: Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of employees belonging to the at-risk population for lung cancer and consequently eligible to lung cancer screening.
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.
Measured: Day 0 (at inclusion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start31 Oct 2020
- Primary completion14 Jan 2021
- Study completion14 Jan 2021
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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 4,595 participants (actual)
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
- NCT04240418
- Sponsor's protocol ID
- ILYAD1_2019
- Acronym
- ILYAD1
- Status last verified
- Jul 2021
- First submitted
- 22 Jan 2020
- Last updated
- 13 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Initiative in LYon for Lung cAncer Screening Development - Prevalence Study
- ClinicalTrials.gov ID
- NCT04240418
- Acronym / sponsor ID
- ILYAD1 / ILYAD1_2019
- Conditions
- Lung Cancer, Screening
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,595 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 31 Oct 2020 (actual)
- Primary completion
- 14 Jan 2021 (actual)
- Study completion
- 14 Jan 2021 (actual)
- First posted
- 27 Jan 2020 (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.
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 design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lyon University Hospital employees | – | Other: Survey |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The Civil Hospices of Lyon is the second largest university hospital in France, with 23000 staff.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Employees not hired by the Lyon University Hospital
- Employees who have not willingness to participate in the survey
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 |
|---|---|---|
| SurveyThe 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. | Other | Lyon University Hospital employees |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer and Screening, run by Hospices Civils de Lyon at 1 site 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 3 inclusion and 2 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: finished, as of the sponsor's last update on 13 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). 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 13 Jul 2021.