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Recruiting NCT07015151

Mobile Lung Cancer Screening

Observational Lung Cancer Prevention

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Low-dose Chest CT Screening, Spirometry, Cardiovascular Risk Assessment, Smoking Cessation Support.
Who it may be relevant to
Registry conditions: Lung Cancer Prevention. Basic parameters: 50 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Lyon Initiative for the Mobile Demedicalized Initiation of Lung Cancer Screening

Overview

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.

Interventions

  • Diagnostic test Low-dose Chest CT Screening
    Participants undergo a low-dose chest CT scan to screen for early lung cancer and assess associated conditions (emphysema, coronary calcifications, osteoporosis).
  • Diagnostic test Spirometry
    Assessment of lung function through spirometry, with optional plethysmography and diffusion testing to detect COPD and PRISM patterns.
  • Diagnostic test Cardiovascular Risk Assessment
    Cardiovascular risk is evaluated using SCORE2/SCORE2-OP tools, based on blood pressure and cholesterol levels.
  • Behavioral Smoking Cessation Support
    Active smokers receive a structured smoking cessation intervention, including a baseline consultation and up to two follow-up sessions (which may be remote).
  • Other Optional Biospecimen Collection (Bio-ILYAD)
    Optional collection of blood and exhaled breath condensate for future analysis of biomarkers in lung cancer detection.

Primary outcome measures

  • Proportion of socially deprived participants included in the mobile screening group [Time frame: Baseline (Day 0)]
Secondary outcome measures (12)
  • 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]

Eligibility criteria

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.
  • Exclusion Criteria \* :
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

France · 2 centers
  • " Centre de dépistage mobile " - Hôpital Lyon Sud — Pierre-Bénite
  • Service de Pneumologie " Centre de dépistage non mobile " - Hôpital Lyon Sud — Pierre-Bénite

Identifiers

NCT: NCT07015151 · 69HCL22_0467 · 2025-A00673-46

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗