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NCT Number: NCT07015151

Mobile 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.

Recruiting

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Key information

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

" Centre de dépistage mobile " - Hôpital Lyon Sud, Pierre-Bénite, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Spirometry

Diagnostic Test

Assessment of lung function through spirometry, with optional plethysmography and diffusion testing to detect COPD and PRISM patterns.

Cardiovascular Risk Assessment

Diagnostic Test

Cardiovascular risk is evaluated using SCORE2/SCORE2-OP tools, based on blood pressure and cholesterol levels.

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).

Optional Biospecimen Collection (Bio-ILYAD)

Other

Optional collection of blood and exhaled breath condensate for future analysis of biomarkers in lung cancer detection.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Participation by socio-demographic profile

    Time frame: Inclusion

    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).

  2. Mobile feasibility

    Time frame: Throughout inclusion period

    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 (%)

  3. Feasibility of task-shifting to nurses

    Time frame: Throughout inclusion period

    Rate of recourse to a physician and participant satisfaction in each modality.

  4. Adherence to intermediate CT scans

    Time frame: Month 1, Month 3, Month 6 if clinically indicated

    Proportion of participants who undergo intermediate follow-up CTs when required.

  5. Adherence to 12-month CT scan

    Time frame: At Month 12

    Proportion of participants who complete the scheduled CT scan at one year.

  6. Adherence to tobacco cessation consultations

    Time frame: Over 12 months

    Proportion of active smokers who attend the initial and, if applicable, follow-up cessation visits.

  7. Smoking cessation success

    Time frame: At 12 months

    Self-reported complete tobacco cessation at 12 months.

  8. Rate of positive screening

    Time frame: Up to 3 months post-initial CT

    Proportion of participants with positive CT findings and subsequent medical workup.

  9. Lung cancer incidence

    Time frame: Over 12 months

    Number and percentage of participants diagnosed with lung cancer during the 12-month follow-up.

  10. COPD detection relevance

    Time frame: Baseline and 12 months

    Rate of new COPD diagnoses and associated therapeutic modifications; respiratory morbidity and mortality over 12 months.

  11. Cardiovascular risk detection relevance

    Time frame: Baseline and 12 months

    Rate of high-risk participants identified, therapeutic implications, cardiovascular events over follow-up.

  12. Creation of biobank (Bio-ILYAD)

    Time frame: At inclusion

    Proportion of participants consenting to blood and exhaled air sample collection for future biomarker research.

  13. Lung cancer staging

    Time frame: Within 12 months

    Distribution of lung cancer cases by stage at diagnosis (I-IV), as recorded in clinical reports. Number of participants per stage

  14. Histological type of diagnosed lung cancers

    Time frame: Within 12 month

    Categorization of diagnosed lung cancers by histological type (e.g., adenocarcinoma, squamous cell carcinoma, small cell). Number of participants per histological category

  15. Initial treatment of diagnosed lung cancers

    Time frame: Within 3 months of diagnosis

    Description and frequency of initial treatment modalities (e.g., surgery, radiotherapy, systemic therapy). Number of participants per treatment type

Other outcomes

  1. Creation of CT image database

    Time frame: Baseline, 6 months and 12 months

    Establishment of a thoracic imaging repository for AI model training and teaching purposes.

Study contacts

Contact information is provided by the study sponsor or research team.

Julie DE-BELMONT

CONTACT

[email protected]

0478866698 ext. +33

Sébastien COURAUD, Pr

CONTACT

[email protected]

04 78 86 44 01 ext. +33

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Lyon Initiative for the Mobile Demedicalized Initiation of Lung Cancer Screening

Acronym: MobILYAD

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jun 11, 2025
Registry last updated
Sep 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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