David O Reilly, Sandra Roche, Claire Noonan, Jack O'Shea, Sinead Toomey, Bryan T Hennessy, Gerard J Fitzmaurice, Keith Egan, Jasmine Dunne, Catriona M Dowling, Ian Counihan, Emmet O'Brien, Imran Sulaiman, Ross Morgan, Benjamin Jacob, Anne-Marie Baird, Seamus Cotter, Donal Bailey, Gavin Maguire, Kathleen Bennett, Jan Sorensen, Nuala A Healy, James Ryan, Patrick Redmond, Daniel J Ryan, Jarushka Naidoo
{"title":"Lung Health Check pilot: Ireland's flagship lung cancer screening trial.","authors":"David O Reilly, Sandra Roche, Claire Noonan, Jack O'Shea, Sinead Toomey, Bryan T Hennessy, Gerard J Fitzmaurice, Keith Egan, Jasmine Dunne, Catriona M Dowling, Ian Counihan, Emmet O'Brien, Imran Sulaiman, Ross Morgan, Benjamin Jacob, Anne-Marie Baird, Seamus Cotter, Donal Bailey, Gavin Maguire, Kathleen Bennett, Jan Sorensen, Nuala A Healy, James Ryan, Patrick Redmond, Daniel J Ryan, Jarushka Naidoo","doi":"10.1136/bmjresp-2024-003035","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>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<sub>M2012</sub>) 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.</p><p><strong>Methods and analysis: </strong>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<sub>M2012</sub>/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.</p><p><strong>Ethics, dissemination and registration details: </strong>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.</p>","PeriodicalId":9048,"journal":{"name":"BMJ Open Respiratory Research","volume":"12 1","pages":""},"PeriodicalIF":3.4000,"publicationDate":"2025-09-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"BMJ Open Respiratory Research","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1136/bmjresp-2024-003035","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"RESPIRATORY SYSTEM","Score":null,"Total":0}
引用次数: 0
Abstract
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 (PLCOM2012) 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 PLCOM2012/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.
期刊介绍:
BMJ Open Respiratory Research is a peer-reviewed, open access journal publishing respiratory and critical care medicine. It is the sister journal to Thorax and co-owned by the British Thoracic Society and BMJ. The journal focuses on robustness of methodology and scientific rigour with less emphasis on novelty or perceived impact. BMJ Open Respiratory Research operates a rapid review process, with continuous publication online, ensuring timely, up-to-date research is available worldwide. The journal publishes review articles and all research study types: Basic science including laboratory based experiments and animal models, Pilot studies or proof of concept, Observational studies, Study protocols, Registries, Clinical trials from phase I to multicentre randomised clinical trials, Systematic reviews and meta-analyses.