Clinical trial NCT07015151: Mobile Lung Cancer Screening
Official title: Lyon Initiative for the Mobile Demedicalized Initiation of Lung Cancer Screening
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Lung Cancer Prevention
Keywords: Prevention
Lung cancer
screening
tobacco
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2025-06-11
Enrollment: 4312
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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 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.


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.

Primary outcomes:
measure: Proportion of socially deprived participants included in the mobile screening group
timeFrame: Baseline (Day 0)
Secondary outcomes:
measure: Participation by socio-demographic profile
timeFrame: Inclusion
measure: Mobile feasibility
timeFrame: Throughout inclusion period
measure: Feasibility of task-shifting to nurses
timeFrame: Throughout inclusion period
measure: Adherence to intermediate CT scans
timeFrame: Month 1, Month 3, Month 6 if clinically indicated
measure: Adherence to 12-month CT scan
timeFrame: At Month 12
measure: Adherence to tobacco cessation consultations
timeFrame: Over 12 months
measure: Smoking cessation success
timeFrame: At 12 months
measure: Rate of positive screening
timeFrame: Up to 3 months post-initial CT
measure: Lung cancer incidence
timeFrame: Over 12 months
measure: COPD detection relevance
timeFrame: Baseline and 12 months
measure: Cardiovascular risk detection relevance
timeFrame: Baseline and 12 months
measure: Creation of biobank (Bio-ILYAD)
timeFrame: At inclusion
measure: Lung cancer staging
timeFrame: Within 12 months
measure: Histological type of diagnosed lung cancers
timeFrame: Within 12 month
measure: Initial treatment of diagnosed lung cancers
timeFrame: Within 3 months of diagnosis
Other outcomes:
measure: Creation of CT image database
timeFrame: Baseline, 6 months and 12 months
Locations:
city: Pierre-Bénite
country: France
facility: " Centre de dépistage mobile " - Hôpital Lyon Sud
city: Pierre-Bénite
country: France
facility: Service de Pneumologie " Centre de dépistage non mobile " - Hôpital Lyon Sud
Study officials:
References: