Yorkshire Lung Screening Trial (YLST): protocol for a randomised controlled trial to evaluate invitation to community-based low-dose CT screening for lung cancer versus usual care in a targeted population at risk

IntroductionLung cancer is the world’s leading cause of cancer death. Low-dose computed tomography (LDCT) screening reduced lung cancer mortality by 20% in the US National Lung Screening Trial. Here, we present the Yorkshire Lung Screening Trial (YLST), which will address key questions of relevance...

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Published in	BMJ open Vol. 10; no. 9; p. e037075
Main Authors	Crosbie, Philip AJ, Gabe, Rhian, Simmonds, Irene, Kennedy, Martyn, Rogerson, Suzanne, Ahmed, Nazia, Baldwin, David R, Booton, Richard, Cochrane, Ann, Darby, Michael, Franks, Kevin, Hinde, Sebastian, Janes, Sam M, Macleod, Una, Messenger, Mike, Moller, Henrik, Murray, Rachael L, Neal, Richard D, Quaife, Samantha L, Sculpher, Mark, Tharmanathan, Puvanendran, Torgerson, David, Callister, Matthew EJ
Format	Journal Article
Language	English
Published	England British Medical Journal Publishing Group 10.09.2020 BMJ Publishing Group LTD BMJ Publishing Group
Series	Protocol
Subjects	Age Aged Aged, 80 and over chest imaging Clinical outcomes Cost analysis Early Detection of Cancer Ethnicity Humans Intervention Lung Lung cancer Lung Neoplasms - diagnostic imaging Medical screening Middle Aged Mortality Ovaries Performance evaluation Population Prostate Quality of Life Randomized Controlled Trials as Topic Respiratory Medicine respiratory tract tumours Risk Factors Socioeconomic factors Task forces Tomography Tomography, X-Ray Computed United Kingdom > UK United States > US chest imaging respiratory tract tumours
Online Access	Get full text
ISSN	2044-6055 2044-6055
DOI	10.1136/bmjopen-2020-037075

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Abstract	IntroductionLung cancer is the world’s leading cause of cancer death. Low-dose computed tomography (LDCT) screening reduced lung cancer mortality by 20% in the US National Lung Screening Trial. Here, we present the Yorkshire Lung Screening Trial (YLST), which will address key questions of relevance for screening implementation.Methods and analysisUsing a single-consent Zelen’s design, ever-smokers aged 55–80 years registered with a general practice in Leeds will be randomised (1:1) to invitation to a telephone-based risk-assessment for a Lung Health Check or to usual care. The anticipated number randomised by household is 62 980 individuals. Responders at high risk will be invited for LDCT scanning for lung cancer on a mobile van in the community. There will be two rounds of screening at an interval of 2 years. Primary objectives are (1) measure participation rates, (2) compare the performance of PLCOM2012 (threshold ≥1.51%), Liverpool Lung Project (V.2) (threshold ≥5%) and US Preventive Services Task Force eligibility criteria for screening population selection and (3) assess lung cancer outcomes in the intervention and usual care arms. Secondary evaluations include health economics, quality of life, smoking rates according to intervention arm, screening programme performance with ancillary biomarker and smoking cessation studies.Ethics and disseminationThe study has been approved by the Greater Manchester West research ethics committee (18-NW-0012) and the Health Research Authority following review by the Confidentiality Advisory Group. The results will be disseminated through publication in peer-reviewed scientific journals, presentation at conferences and on the YLST website.Trial registration numbersISRCTN42704678 and NCT03750110.
AbstractList	IntroductionLung cancer is the world’s leading cause of cancer death. Low-dose computed tomography (LDCT) screening reduced lung cancer mortality by 20% in the US National Lung Screening Trial. Here, we present the Yorkshire Lung Screening Trial (YLST), which will address key questions of relevance for screening implementation.Methods and analysisUsing a single-consent Zelen’s design, ever-smokers aged 55–80 years registered with a general practice in Leeds will be randomised (1:1) to invitation to a telephone-based risk-assessment for a Lung Health Check or to usual care. The anticipated number randomised by household is 62 980 individuals. Responders at high risk will be invited for LDCT scanning for lung cancer on a mobile van in the community. There will be two rounds of screening at an interval of 2 years. Primary objectives are (1) measure participation rates, (2) compare the performance of PLCOM2012 (threshold ≥1.51%), Liverpool Lung Project (V.2) (threshold ≥5%) and US Preventive Services Task Force eligibility criteria for screening population selection and (3) assess lung cancer outcomes in the intervention and usual care arms. Secondary evaluations include health economics, quality of life, smoking rates according to intervention arm, screening programme performance with ancillary biomarker and smoking cessation studies.Ethics and disseminationThe study has been approved by the Greater Manchester West research ethics committee (18-NW-0012) and the Health Research Authority following review by the Confidentiality Advisory Group. The results will be disseminated through publication in peer-reviewed scientific journals, presentation at conferences and on the YLST website.Trial registration numbersISRCTN42704678 and NCT03750110. Introduction Lung cancer is the world’s leading cause of cancer death. Low-dose computed tomography (LDCT) screening reduced lung cancer mortality by 20% in the US National Lung Screening Trial. Here, we present the Yorkshire Lung Screening Trial (YLST), which will address key questions of relevance for screening implementation.Methods and analysis Using a single-consent Zelen’s design, ever-smokers aged 55–80 years registered with a general practice in Leeds will be randomised (1:1) to invitation to a telephone-based risk-assessment for a Lung Health Check or to usual care. The anticipated number randomised by household is 62 980 individuals. Responders at high risk will be invited for LDCT scanning for lung cancer on a mobile van in the community. There will be two rounds of screening at an interval of 2 years. Primary objectives are (1) measure participation rates, (2) compare the performance of PLCOM2012 (threshold ≥1.51%), Liverpool Lung Project (V.2) (threshold ≥5%) and US Preventive Services Task Force eligibility criteria for screening population selection and (3) assess lung cancer outcomes in the intervention and usual care arms. Secondary evaluations include health economics, quality of life, smoking rates according to intervention arm, screening programme performance with ancillary biomarker and smoking cessation studies.Ethics and dissemination The study has been approved by the Greater Manchester West research ethics committee (18-NW-0012) and the Health Research Authority following review by the Confidentiality Advisory Group. The results will be disseminated through publication in peer-reviewed scientific journals, presentation at conferences and on the YLST website.Trial registration numbers ISRCTN42704678 and NCT03750110. Lung cancer is the world's leading cause of cancer death. Low-dose computed tomography (LDCT) screening reduced lung cancer mortality by 20% in the US National Lung Screening Trial. Here, we present the Yorkshire Lung Screening Trial (YLST), which will address key questions of relevance for screening implementation.INTRODUCTIONLung cancer is the world's leading cause of cancer death. Low-dose computed tomography (LDCT) screening reduced lung cancer mortality by 20% in the US National Lung Screening Trial. Here, we present the Yorkshire Lung Screening Trial (YLST), which will address key questions of relevance for screening implementation.Using a single-consent Zelen's design, ever-smokers aged 55-80 years registered with a general practice in Leeds will be randomised (1:1) to invitation to a telephone-based risk-assessment for a Lung Health Check or to usual care. The anticipated number randomised by household is 62 980 individuals. Responders at high risk will be invited for LDCT scanning for lung cancer on a mobile van in the community. There will be two rounds of screening at an interval of 2 years. Primary objectives are (1) measure participation rates, (2) compare the performance of PLCOM2012 (threshold ≥1.51%), Liverpool Lung Project (V.2) (threshold ≥5%) and US Preventive Services Task Force eligibility criteria for screening population selection and (3) assess lung cancer outcomes in the intervention and usual care arms. Secondary evaluations include health economics, quality of life, smoking rates according to intervention arm, screening programme performance with ancillary biomarker and smoking cessation studies.METHODS AND ANALYSISUsing a single-consent Zelen's design, ever-smokers aged 55-80 years registered with a general practice in Leeds will be randomised (1:1) to invitation to a telephone-based risk-assessment for a Lung Health Check or to usual care. The anticipated number randomised by household is 62 980 individuals. Responders at high risk will be invited for LDCT scanning for lung cancer on a mobile van in the community. There will be two rounds of screening at an interval of 2 years. Primary objectives are (1) measure participation rates, (2) compare the performance of PLCOM2012 (threshold ≥1.51%), Liverpool Lung Project (V.2) (threshold ≥5%) and US Preventive Services Task Force eligibility criteria for screening population selection and (3) assess lung cancer outcomes in the intervention and usual care arms. Secondary evaluations include health economics, quality of life, smoking rates according to intervention arm, screening programme performance with ancillary biomarker and smoking cessation studies.The study has been approved by the Greater Manchester West research ethics committee (18-NW-0012) and the Health Research Authority following review by the Confidentiality Advisory Group. The results will be disseminated through publication in peer-reviewed scientific journals, presentation at conferences and on the YLST website.ETHICS AND DISSEMINATIONThe study has been approved by the Greater Manchester West research ethics committee (18-NW-0012) and the Health Research Authority following review by the Confidentiality Advisory Group. The results will be disseminated through publication in peer-reviewed scientific journals, presentation at conferences and on the YLST website.ISRCTN42704678 and NCT03750110.TRIAL REGISTRATION NUMBERSISRCTN42704678 and NCT03750110. Lung cancer is the world's leading cause of cancer death. Low-dose computed tomography (LDCT) screening reduced lung cancer mortality by 20% in the US National Lung Screening Trial. Here, we present the Yorkshire Lung Screening Trial (YLST), which will address key questions of relevance for screening implementation. Using a single-consent Zelen's design, ever-smokers aged 55-80 years registered with a general practice in Leeds will be randomised (1:1) to invitation to a telephone-based risk-assessment for a Lung Health Check or to usual care. The anticipated number randomised by household is 62 980 individuals. Responders at high risk will be invited for LDCT scanning for lung cancer on a mobile van in the community. There will be two rounds of screening at an interval of 2 years. Primary objectives are (1) measure participation rates, (2) compare the performance of PLCO (threshold ≥1.51%), Liverpool Lung Project (V.2) (threshold ≥5%) and US Preventive Services Task Force eligibility criteria for screening population selection and (3) assess lung cancer outcomes in the intervention and usual care arms. Secondary evaluations include health economics, quality of life, smoking rates according to intervention arm, screening programme performance with ancillary biomarker and smoking cessation studies. The study has been approved by the Greater Manchester West research ethics committee (18-NW-0012) and the Health Research Authority following review by the Confidentiality Advisory Group. The results will be disseminated through publication in peer-reviewed scientific journals, presentation at conferences and on the YLST website. ISRCTN42704678 and NCT03750110.
Author	Darby, Michael Ahmed, Nazia Gabe, Rhian Crosbie, Philip AJ Kennedy, Martyn Rogerson, Suzanne Sculpher, Mark Moller, Henrik Neal, Richard D Torgerson, David Booton, Richard Franks, Kevin Messenger, Mike Quaife, Samantha L Hinde, Sebastian Cochrane, Ann Janes, Sam M Tharmanathan, Puvanendran Callister, Matthew EJ Simmonds, Irene Macleod, Una Murray, Rachael L Baldwin, David R
AuthorAffiliation	1 Division of Infection, Immunity and Respiratory Medicine , The University of Manchester , Manchester , UK 16 Division of Epidemiology and Public Health, Faculty of Medicine , University of Nottingham , Nottingham , UK 5 Department of Research and Innovation , Leeds Teaching Hospitals NHS Trust , Leeds , UK 9 Department of Radiology , Leeds Teaching Hospitals NHS Trust , Leeds , UK 3 Leeds Institute of Health Sciences, University of Leeds , Leeds , UK 7 Lung Cancer and Thoracic Surgery Directorate, Heart and Lung Division , Manchester University NHS Foundation Trust , Manchester , UK 17 Research Department of Epidemiology and Public Health , University College London , London , UK 14 Leeds Centre for Personalised Medicine and Health , University of Leeds , Leeds , UK 11 Centre for Health Economics , University of York , York , UK 10 Leeds Cancer Centre , Leeds Teaching Hospitals NHS Trust , Leeds , UK 15 Thames Cancer Registry , Kings College London , London , UK 4 Department of Respiratory Medi
AuthorAffiliation_xml	– name: 15 Thames Cancer Registry , Kings College London , London , UK – name: 17 Research Department of Epidemiology and Public Health , University College London , London , UK – name: 13 Hull York Medical School , University of Hull , Hull , UK – name: 9 Department of Radiology , Leeds Teaching Hospitals NHS Trust , Leeds , UK – name: 6 Department of Respiratory Medicine, City Campus , Nottingham University Hospitals , Nottingham , UK – name: 7 Lung Cancer and Thoracic Surgery Directorate, Heart and Lung Division , Manchester University NHS Foundation Trust , Manchester , UK – name: 8 York Trials Unit, Department of Health Sciences , University of York , York , UK – name: 3 Leeds Institute of Health Sciences, University of Leeds , Leeds , UK – name: 5 Department of Research and Innovation , Leeds Teaching Hospitals NHS Trust , Leeds , UK – name: 14 Leeds Centre for Personalised Medicine and Health , University of Leeds , Leeds , UK – name: 1 Division of Infection, Immunity and Respiratory Medicine , The University of Manchester , Manchester , UK – name: 2 Centre for Cancer Prevention, Wolfson Institute of Preventive Medicine , Queen Mary University of London , London , UK – name: 4 Department of Respiratory Medicine, Leeds Teaching Hospitals NHS Trust , Leeds , UK – name: 11 Centre for Health Economics , University of York , York , UK – name: 16 Division of Epidemiology and Public Health, Faculty of Medicine , University of Nottingham , Nottingham , UK – name: 10 Leeds Cancer Centre , Leeds Teaching Hospitals NHS Trust , Leeds , UK – name: 12 Department of Respiratory Medicine , University College London , London , UK
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BackLink	https://www.ncbi.nlm.nih.gov/pubmed/32912947$$D View this record in MEDLINE/PubMed
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Keywords	chest imaging respiratory tract tumours
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low-dose CT screening pilot publication-title: Lung Cancer doi: 10.1016/j.lungcan.2018.10.029
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Snippet	IntroductionLung cancer is the world’s leading cause of cancer death. Low-dose computed tomography (LDCT) screening reduced lung cancer mortality by 20% in the... Lung cancer is the world's leading cause of cancer death. Low-dose computed tomography (LDCT) screening reduced lung cancer mortality by 20% in the US National... Introduction Lung cancer is the world’s leading cause of cancer death. Low-dose computed tomography (LDCT) screening reduced lung cancer mortality by 20% in...
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SubjectTerms	Age Aged Aged, 80 and over chest imaging Clinical outcomes Cost analysis Early Detection of Cancer Ethnicity Humans Intervention Lung Lung cancer Lung Neoplasms - diagnostic imaging Medical screening Middle Aged Mortality Ovaries Performance evaluation Population Prostate Quality of Life Randomized Controlled Trials as Topic Respiratory Medicine respiratory tract tumours Risk Factors Socioeconomic factors Task forces Tomography Tomography, X-Ray Computed
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Title	Yorkshire Lung Screening Trial (YLST): protocol for a randomised controlled trial to evaluate invitation to community-based low-dose CT screening for lung cancer versus usual care in a targeted population at risk
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