Lung Health Check pilot: Ireland's flagship lung cancer screening trial.

Introduction: Low-dose chest CT (LDCT) has demonstrated the ability to detect early-stage lung cancer (LC) and improve disease-specific mortality in high-risk individuals. Use of LC risk scores such as the Prostate, Lung, Colorectal, Ovarian Model Score (PLCO_M2012) improves the sensitivity, specificity and positive predictive value for LC screening. Screening programmes have identified that primary care participation, patient engagement and improved accessibility may enhance the success of LC screening. Currently, there is no LC screening programme in Ireland. This first pilot study of LC screening will investigate (1) the feasibility, including uptake, of LC screening in a community setting, based on primary care-based participant invitation with mobile CT scanning and (2) novel blood/breath biomarkers in high-risk individuals who participate in the LC screening trial, to identify biologic parameters that may supplement existing risk scores, to maximise LC early detection.

Methods and analysis: In a pilot feasibility clinical trial, approximately 30 000 adults aged between 55 and 74 from participating general practitioner (GP) practices will be invited to a 'lung health check (LHC)' prescreening, involving a telephone assessment of eligibility and risk status, based on the PLCO_M2012/Liverpool Score V.2. High-risk individuals will be invited to the LHC, which will take place in a mobile unit strategically located in the community and include a respiratory disease assessment, baseline spirometry, smoking cessation advice, an LDCT and in a selected cohort, blood/breath/sputum biospecimen collection. Two rounds of screening will take place at an interval of 12 months.

Ethics, dissemination and registration details: In this pilot feasibility trial, the uptake of LC screening using a community-based strategy among high-risk participants will be investigated. The study has been approved by Beaumont Hospital Research Ethics Committee and is registered with clinicaltrials.gov (NCT07099027). Novel features of our design include directly calling participants and our translational arm of the study, which will focus on blood/breath/sputum biomarkers associated with LC.