Lung Cancer PreventionMobILYADNCT07015151
Mobile Lung Cancer Screening
An observational study of Lung Cancer Prevention, run by Hospices Civils de Lyon at 2 sites in France.
Trial summary
Lung cancer screening using low-dose CT (LDCT) has been shown to reduce mortality in high-risk populations. In 2022, the French National Cancer Institute (INCa) issued guidelines recommending screening for individuals aged 50-74 with a history of heavy smoking, including current smokers or those who quit less than 15… Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer Prevention
- What is being tested?
- Low-dose Chest CT Screening, Spirometry and Cardiovascular Risk Assessment
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 4,312 participants
- Where
- 2 sitesFrance
- Study dates
- 12 Jun 2025to Sep 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults aged 50 to 74 years with a significant history of smoking, currently smoking or former smokers who quit within the past 15 years. The study targets individuals eligible for lung cancer screening per national guidelines, with a focus on those from socially deprived backgrounds. Recruitment will be carried out through a mobile screening unit or a fixed hospital site, depending on geographic location.
Who may be able to join
- Persons aged over 50 and under 75 (74 years of age or older).
- Active smokers or former smokers who quit less than 15 years ago.
- Persons whose consumption is estimated at 20 packs/year or more, down to ≥15 cigarettes/day for a duration of consumption of ≥25 years and up to ≥10 cigarettes/day for ≥30 years, which takes into account the predominance of duration of consumption over quantity consumed in the risk of lung cancer. A pack-year corresponds to the consumption of one pack of 20 manufactured cigarettes per day for one year. A multiplier coefficient will be taken into account depending on the mode of consumption: Rolled cigarettes: 2; Cigarillos: 3; Cigars: 4; Pipes: 2.5; Hookahs: 25.
- Persons affiliated with social security. - Person having signed their consent to participate in the study after having received full information about it, including the risks associated with participation.
Who cannot join
- Individuals with severe comorbidities contraindicating lung cancer investigations and/or treatment (including surgery or stereotactic radiotherapy);
- Individuals with impaired general condition (PS 2 and above);
- Individuals with dyspnea at rest (mMRC4);
- Individuals with a history of cancer undergoing active surveillance by chest computed tomography (CT or PET scan); personal history of lung cancer (lifetime);
- Individuals with symptoms suggestive of lung cancer (hemoptysis, unexplained weight loss, recent onset or change in respiratory symptoms, etc.);
- Individuals refusing to participate in the study
- Individuals withdrawing their consent.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
" Centre de dépistage mobile " - Hôpital Lyon Sud
Pierre-Bénite, 69310
Sébastien COURAUD, Pr, 00334 78 86 44 01, sebastien.couraud@chu-lyon.fr
- Recruiting
Service de Pneumologie " Centre de dépistage non mobile " - Hôpital Lyon Sud
Pierre-Bénite, 69310
COURAUD Sébastien, Pr, 0033 4 78 86 44 01, sebastien.couraud@chu-lyon.fr
About this study
Official title: Lyon Initiative for the Mobile Demedicalized Initiation of Lung Cancer Screening
Lung cancer screening using low-dose CT (LDCT) has been shown to reduce mortality in high-risk populations. In 2022, the French National Cancer Institute (INCa) issued guidelines recommending screening for individuals aged 50-74 with a history of heavy smoking, including current smokers or those who quit less than 15 years ago. A national pilot program (IMPULSION) will be launched in 2025.
Lung cancer incidence is strongly correlated with socioeconomic status, yet underserved populations remain difficult to engage in screening programs. Mobile health units using a "reach-out" strategy have demonstrated effectiveness in other countries (UK, Brazil, USA). In France, this approach has been used for breast cancer screening via mobile mammography units.
The MobILYAD project aims to compare two screening modalities- a mobile demedicalized unit (CT-equipped van with trained nurses) and a conventional hospital-based unit- to assess the effectiveness of mobile screening in reaching socially disadvantaged populations.
- Conditions
- Lung Cancer Prevention
- Being tested
- Low-dose Chest CT Screening, Spirometry, Cardiovascular Risk Assessment, Smoking Cessation Support, Optional Biospecimen Collection (Bio-ILYAD)
- Keywords
- Prevention, Lung cancer, screening, tobacco
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-dose Chest CT ScreeningDiagnostic test
Participants undergo a low-dose chest CT scan to screen for early lung cancer and assess associated conditions (emphysema, coronary calcifications, osteoporosis).
SpirometryDiagnostic test
Assessment of lung function through spirometry, with optional plethysmography and diffusion testing to detect COPD and PRISM patterns.
Cardiovascular Risk AssessmentDiagnostic test
Cardiovascular risk is evaluated using SCORE2/SCORE2-OP tools, based on blood pressure and cholesterol levels.
Smoking Cessation SupportBehavioural
Active smokers receive a structured smoking cessation intervention, including a baseline consultation and up to two follow-up sessions (which may be remote).
Optional Biospecimen Collection (Bio-ILYAD)Other
Optional collection of blood and exhaled breath condensate for future analysis of biomarkers in lung cancer detection.
| Study group | Role | What they receive |
|---|---|---|
| Mobile Screening Group | Participants receiving lung cancer screening via a mobile unit (truck) operated by trained nurses. This includes spirometry, blood pressure measurement, blood cholesterol testing, low-dose CT scan, and optional biospecimen collection. Receives: Diagnostic Test: Low-dose Chest CT Screening; Diagnostic Test: Spirometry; Diagnostic Test: Cardiovascular Risk Assessment; Behavioral: Smoking Cessation Support; Other: Optional Biospecimen Collection (Bio-ILYAD) | |
| Non-Mobile Screening Group | Participants receiving the same screening procedures at a fixed hospital-based site (Lyon Sud), with possible involvement of medical or non-medical staff depending on availability. Receives: Diagnostic Test: Low-dose Chest CT Screening; Diagnostic Test: Spirometry; Diagnostic Test: Cardiovascular Risk Assessment; Behavioral: Smoking Cessation Support; Other: Optional Biospecimen Collection (Bio-ILYAD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of socially deprived participants included in the mobile screening group
The percentage of participants with an EPICES score ≥ 4 (indicating social vulnerability) in the mobile screening arm, compared to the non-mobile arm.
Measured: Baseline (Day 0)
Secondary outcomes (15)
Participation by socio-demographic profile
Comparison of participants' characteristics between the two modalities (smoking status, age, sex, socio-professional category, income level, education, perceived ethnic identity, geographic isolation, presence of a general practitioner).
Measured: Inclusion
Mobile feasibility
Feasibility of the mobile screening pathway, assessed by the attendance rate (proportion of invited participants who attend the mobile unit) and the completion rate (proportion of those attendees who complete the full screening process). Both will be reported separately as percentages.
Unit of Measure: Percentage of participants (%)
Measured: Throughout inclusion period
Feasibility of task-shifting to nurses
Rate of recourse to a physician and participant satisfaction in each modality.
Measured: Throughout inclusion period
Adherence to intermediate CT scans
Proportion of participants who undergo intermediate follow-up CTs when required.
Measured: Month 1, Month 3, Month 6 if clinically indicated
Adherence to 12-month CT scan
Proportion of participants who complete the scheduled CT scan at one year.
Measured: At Month 12
Adherence to tobacco cessation consultations
Proportion of active smokers who attend the initial and, if applicable, follow-up cessation visits.
Measured: Over 12 months
Smoking cessation success
Self-reported complete tobacco cessation at 12 months.
Measured: At 12 months
Rate of positive screening
Proportion of participants with positive CT findings and subsequent medical workup.
Measured: Up to 3 months post-initial CT
Lung cancer incidence
Number and percentage of participants diagnosed with lung cancer during the 12-month follow-up.
Measured: Over 12 months
COPD detection relevance
Rate of new COPD diagnoses and associated therapeutic modifications; respiratory morbidity and mortality over 12 months.
Measured: Baseline and 12 months
Cardiovascular risk detection relevance
Rate of high-risk participants identified, therapeutic implications, cardiovascular events over follow-up.
Measured: Baseline and 12 months
Creation of biobank (Bio-ILYAD)
Proportion of participants consenting to blood and exhaled air sample collection for future biomarker research.
Measured: At inclusion
Lung cancer staging
Distribution of lung cancer cases by stage at diagnosis (I-IV), as recorded in clinical reports. Number of participants per stage
Measured: Within 12 months
Histological type of diagnosed lung cancers
Categorization of diagnosed lung cancers by histological type (e.g., adenocarcinoma, squamous cell carcinoma, small cell). Number of participants per histological category
Measured: Within 12 month
Initial treatment of diagnosed lung cancers
Description and frequency of initial treatment modalities (e.g., surgery, radiotherapy, systemic therapy). Number of participants per treatment type
Measured: Within 3 months of diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2025
- Study start12 Jun 2025
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer PreventionStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,312 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
- NCT07015151
- Sponsor's protocol ID
- 69HCL22_0467
- Other IDs
- 2025-A00673-46
- Acronym
- MobILYAD
- Status last verified
- Sep 2025
- First submitted
- 3 Jun 2025
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: A decision on sharing individual participant data has not yet been made. Data sharing will depend on sponsor policy, ethical approval, and compliance with applicable regulations.
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lyon Initiative for the Mobile Demedicalized Initiation of Lung Cancer Screening
- ClinicalTrials.gov ID
- NCT07015151
- Acronym / sponsor ID
- MobILYAD / 69HCL22_0467
- Conditions
- Lung Cancer Prevention
- Keywords
- Prevention, Lung cancer, screening, tobacco
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 4,312 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 12 Jun 2025 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 11 Jun 2025 (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.
Lung cancer screening using low-dose CT (LDCT) has been shown to reduce mortality in high-risk populations. In 2022, the French National Cancer Institute (INCa) issued guidelines recommending screening for individuals aged 50-74 with a history of heavy smoking, including current smokers or those who quit less than 15 years ago. A national pilot program (IMPULSION) will be launched in 2025.
Lung cancer incidence is strongly correlated with socioeconomic status, yet underserved populations remain difficult to engage in screening programs. Mobile health units using a "reach-out" strategy have demonstrated effectiveness in other countries (UK, Brazil, USA). In France, this approach has been used for breast cancer screening via mobile mammography units.
The MobILYAD project aims to compare two screening modalities- a mobile demedicalized unit (CT-equipped van with trained nurses) and a conventional hospital-based unit- to assess the effectiveness of mobile screening in reaching socially disadvantaged populations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mobile Screening Group | – | Diagnostic Test: Low-dose Chest CT Screening, Diagnostic Test: Spirometry, Diagnostic Test: Cardiovascular Risk Assessment, Behavioral: Smoking Cessation Support, Other: Optional Biospecimen Collection (Bio-ILYAD)Participants receiving lung cancer screening via a mobile unit (truck) operated by trained nurses. This includes spirometry, blood pressure measurement, blood cholesterol testing, low-dose CT scan, and optional biospecimen collection. |
| Non-Mobile Screening Group | – | Diagnostic Test: Low-dose Chest CT Screening, Diagnostic Test: Spirometry, Diagnostic Test: Cardiovascular Risk Assessment, Behavioral: Smoking Cessation Support, Other: Optional Biospecimen Collection (Bio-ILYAD)Participants receiving the same screening procedures at a fixed hospital-based site (Lyon Sud), with possible involvement of medical or non-medical staff depending on availability. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults aged 50 to 74 years with a significant history of smoking, currently smoking or former smokers who quit within the past 15 years. The study targets individuals eligible for lung cancer screening per national guidelines, with a focus on those from socially deprived backgrounds. Recruitment will be carried out through a mobile screening unit or a fixed hospital site, depending on geographic location.
Key inclusion criteria (4 listed)
- Persons aged over 50 and under 75 (74 years of age or older).
- Active smokers or former smokers who quit less than 15 years ago.
- Persons whose consumption is estimated at 20 packs/year or more, down to ≥15 cigarettes/day for a duration of consumption of ≥25 years and up to ≥10 cigarettes/day for ≥30 years, which takes into account the predominance of duration of consumption over quantity consumed in the risk of lung cancer. A pack-year corresponds to the consumption of one pack of 20 manufactured cigarettes per day for one year. A multiplier coefficient will be taken into account depending on the mode of consumption: Rolled cigarettes: 2; Cigarillos: 3; Cigars: 4; Pipes: 2.5; Hookahs: 25.
- Persons affiliated with social security. - Person having signed their consent to participate in the study after having received full information about it, including the risks associated with participation.
Key exclusion criteria (7 listed)
- Individuals with severe comorbidities contraindicating lung cancer investigations and/or treatment (including surgery or stereotactic radiotherapy);
- Individuals with impaired general condition (PS 2 and above);
- Individuals with dyspnea at rest (mMRC4);
- Individuals with a history of cancer undergoing active surveillance by chest computed tomography (CT or PET scan); personal history of lung cancer (lifetime);
- Individuals with symptoms suggestive of lung cancer (hemoptysis, unexplained weight loss, recent onset or change in respiratory symptoms, etc.);
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 |
|---|---|---|
| Low-dose Chest CT ScreeningParticipants undergo a low-dose chest CT scan to screen for early lung cancer and assess associated conditions (emphysema, coronary calcifications, osteoporosis). | Diagnostic test | Mobile Screening Group, Non-Mobile Screening Group |
| SpirometryAssessment of lung function through spirometry, with optional plethysmography and diffusion testing to detect COPD and PRISM patterns. | Diagnostic test | Mobile Screening Group, Non-Mobile Screening Group |
| Cardiovascular Risk AssessmentCardiovascular risk is evaluated using SCORE2/SCORE2-OP tools, based on blood pressure and cholesterol levels. | Diagnostic test | Mobile Screening Group, Non-Mobile Screening Group |
| Smoking Cessation SupportActive smokers receive a structured smoking cessation intervention, including a baseline consultation and up to two follow-up sessions (which may be remote). | Behavioural | Mobile Screening Group, Non-Mobile Screening Group |
| Optional Biospecimen Collection (Bio-ILYAD)Optional collection of blood and exhaled breath condensate for future analysis of biomarkers in lung cancer detection. | Other | Mobile Screening Group, Non-Mobile Screening Group |
Primary outcome
Proportion of socially deprived participants included in the mobile screening group
Time frame: Baseline (Day 0)
The percentage of participants with an EPICES score ≥ 4 (indicating social vulnerability) in the mobile screening arm, compared to the non-mobile arm.
15 secondary outcomes
Participation by socio-demographic profile
Time frame: Inclusion
Mobile feasibility
Time frame: Throughout inclusion period
Feasibility of task-shifting to nurses
Time frame: Throughout inclusion period
Adherence to intermediate CT scans
Time frame: Month 1, Month 3, Month 6 if clinically indicated
Adherence to 12-month CT scan
Time frame: At Month 12
Adherence to tobacco cessation consultations
Time frame: Over 12 months
Smoking cessation success
Time frame: At 12 months
Rate of positive screening
Time frame: Up to 3 months post-initial CT
Lung cancer incidence
Time frame: Over 12 months
COPD detection relevance
Time frame: Baseline and 12 months
Cardiovascular risk detection relevance
Time frame: Baseline and 12 months
Creation of biobank (Bio-ILYAD)
Time frame: At inclusion
Lung cancer staging
Time frame: Within 12 months
Histological type of diagnosed lung cancers
Time frame: Within 12 month
Initial treatment of diagnosed lung cancers
Time frame: Within 3 months of diagnosis
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
- Individual participant dataSharing planned: Undecided. A decision on sharing individual participant data has not yet been made. Data sharing will depend on sponsor policy, ethical approval, and compliance with applicable regulations.
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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.
2 sites 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 Prevention, run by Hospices Civils de Lyon at 2 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 4 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sébastien COURAUD, Pr (04 78 86 44 01 ext. +33, 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?
Proportion of socially deprived participants included in the mobile screening group (time frame: Baseline (Day 0)). 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 9 Sep 2025.