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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-A00673-46 | Other Identifier | ID-RCB |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low-dose Chest CT Screening | Diagnostic Test | Participants undergo a low-dose chest CT scan to screen for early lung cancer and assess associated conditions (emphysema, coronary calcifications, osteoporosis). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (Day 0) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Inclusion |
| Mobile feasibility |
| Measure | Description | Time Frame |
|---|---|---|
| Creation of CT image database | Establishment of a thoracic imaging repository for AI model training and teaching purposes. | Baseline, 6 months and 12 months |
Inclusion Criteria * :
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.
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.
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sébastien COURAUD, Pr | Contact | 04 78 86 44 01 | +33 | sebastien.couraud@chu-lyon.fr |
| Julie DE-BELMONT | Contact | 0478866698 | +33 | Julie.de-bermont@chu-lyon.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| " Centre de dépistage mobile " - Hôpital Lyon Sud | Recruiting | Pierre-Bénite | 69310 | France |
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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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D013147 | Spirometry |
| ID | Term |
|---|---|
| D012129 | Respiratory Function Tests |
| D003948 | Diagnostic Techniques, Respiratory System |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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The following types of biospecimens will be retained for ancillary analyses:
These specimens will be collected at baseline and at the end of the intervention phase, then stored for subsequent analysis in the context of the Bio-ILYAD study (biobank).
| Spirometry | Diagnostic Test | Assessment of lung function through spirometry, with optional plethysmography and diffusion testing to detect COPD and PRISM patterns. |
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| Cardiovascular Risk Assessment | Diagnostic Test | Cardiovascular risk is evaluated using SCORE2/SCORE2-OP tools, based on blood pressure and cholesterol levels. |
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| Smoking Cessation Support | Behavioral | Active smokers receive a structured smoking cessation intervention, including a baseline consultation and up to two follow-up sessions (which may be remote). |
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| Optional Biospecimen Collection (Bio-ILYAD) | Other | Optional collection of blood and exhaled breath condensate for future analysis of biomarkers in lung cancer detection. |
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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 (%) |
| Throughout inclusion period |
| Feasibility of task-shifting to nurses | Rate of recourse to a physician and participant satisfaction in each modality. | Throughout inclusion period |
| Adherence to intermediate CT scans | Proportion of participants who undergo intermediate follow-up CTs when required. | 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. | At Month 12 |
| Adherence to tobacco cessation consultations | Proportion of active smokers who attend the initial and, if applicable, follow-up cessation visits. | Over 12 months |
| Smoking cessation success | Self-reported complete tobacco cessation at 12 months. | At 12 months |
| Rate of positive screening | Proportion of participants with positive CT findings and subsequent medical workup. | 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. | Over 12 months |
| COPD detection relevance | Rate of new COPD diagnoses and associated therapeutic modifications; respiratory morbidity and mortality over 12 months. | Baseline and 12 months |
| Cardiovascular risk detection relevance | Rate of high-risk participants identified, therapeutic implications, cardiovascular events over follow-up. | Baseline and 12 months |
| Creation of biobank (Bio-ILYAD) | Proportion of participants consenting to blood and exhaled air sample collection for future biomarker research. | 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 | 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 | 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 | Within 3 months of diagnosis |
| Service de Pneumologie " Centre de dépistage non mobile " - Hôpital Lyon Sud | Recruiting | Pierre-Bénite | 69310 | France |
|
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |