Mobile Lung Cancer Screening

Официальное название

Lyon Initiative for the Mobile Demedicalized Initiation of Lung Cancer Screening

Обзор

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.

Вмешательства

• Диагностический тест 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).
• Диагностический тест Spirometry
  Assessment of lung function through spirometry, with optional plethysmography and diffusion testing to detect COPD and PRISM patterns.
• Диагностический тест Cardiovascular Risk Assessment
  Cardiovascular risk is evaluated using SCORE2/SCORE2-OP tools, based on blood pressure and cholesterol levels.
• Поведенческое 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).
• Другое Optional Biospecimen Collection (Bio-ILYAD)
  Optional collection of blood and exhaled breath condensate for future analysis of biomarkers in lung cancer detection.

Первичные конечные точки

• Proportion of socially deprived participants included in the mobile screening group [Срок оценки: Baseline (Day 0)]

Вторичные конечные точки (12)

• Participation by socio-demographic profile [Срок оценки: Inclusion]
• Mobile feasibility [Срок оценки: Throughout inclusion period]
• Feasibility of task-shifting to nurses [Срок оценки: Throughout inclusion period]
• Adherence to intermediate CT scans [Срок оценки: Month 1, Month 3, Month 6 if clinically indicated]
• Adherence to 12-month CT scan [Срок оценки: At Month 12]
• Adherence to tobacco cessation consultations [Срок оценки: Over 12 months]
• Smoking cessation success [Срок оценки: At 12 months]
• Rate of positive screening [Срок оценки: Up to 3 months post-initial CT]
• Lung cancer incidence [Срок оценки: Over 12 months]
• COPD detection relevance [Срок оценки: Baseline and 12 months]
• Cardiovascular risk detection relevance [Срок оценки: Baseline and 12 months]
• Creation of biobank (Bio-ILYAD) [Срок оценки: At inclusion]

Критерии участия

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Франция · 2 центра

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

Идентификаторы

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

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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