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

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...

Full description

Saved in:
Bibliographic Details
Main Authors: Richard D Neal, Kevin Franks, David Torgerson, Rachael L Murray, David R Baldwin, Michael Darby, Henrik Moller, Richard Booton, Una MacLeod, Sam M Janes, Samantha L Quaife, Sebastian Hinde, Matthew EJ Callister, Suzanne Rogerson, Rhian Gabe, Mark Sculpher, Philip AJ Crosbie, Irene Simmonds, Martyn Kennedy, Nazia Ahmed, Ann Cochrane, Mike Messenger, Puvanendran Tharmanathan
Format: Article
Language:English
Published: BMJ Publishing Group 2020-09-01
Series:BMJ Open
Online Access:https://bmjopen.bmj.com/content/10/9/e037075.full
Tags: Add Tag
No Tags, Be the first to tag this record!
_version_ 1841556209110351872
author Richard D Neal
Kevin Franks
David Torgerson
Rachael L Murray
David R Baldwin
Michael Darby
Henrik Moller
Richard Booton
Una MacLeod
Sam M Janes
Samantha L Quaife
Sebastian Hinde
Matthew EJ Callister
Suzanne Rogerson
Rhian Gabe
Mark Sculpher
Philip AJ Crosbie
Irene Simmonds
Martyn Kennedy
Nazia Ahmed
Ann Cochrane
Mike Messenger
Puvanendran Tharmanathan
author_facet Richard D Neal
Kevin Franks
David Torgerson
Rachael L Murray
David R Baldwin
Michael Darby
Henrik Moller
Richard Booton
Una MacLeod
Sam M Janes
Samantha L Quaife
Sebastian Hinde
Matthew EJ Callister
Suzanne Rogerson
Rhian Gabe
Mark Sculpher
Philip AJ Crosbie
Irene Simmonds
Martyn Kennedy
Nazia Ahmed
Ann Cochrane
Mike Messenger
Puvanendran Tharmanathan
author_sort Richard D Neal
collection DOAJ
description 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.
format Article
id doaj-art-141871bf552c45debd3c2f5f5adaf27c
institution Kabale University
issn 2044-6055
language English
publishDate 2020-09-01
publisher BMJ Publishing Group
record_format Article
series BMJ Open
spelling doaj-art-141871bf552c45debd3c2f5f5adaf27c2025-01-07T11:35:12ZengBMJ Publishing GroupBMJ Open2044-60552020-09-0110910.1136/bmjopen-2020-037075Yorkshire 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 riskRichard D Neal0Kevin Franks1David Torgerson2Rachael L Murray3David R Baldwin4Michael Darby5Henrik Moller6Richard Booton7Una MacLeod8Sam M Janes9Samantha L Quaife10Sebastian Hinde11Matthew EJ Callister12Suzanne Rogerson13Rhian Gabe14Mark Sculpher15Philip AJ Crosbie16Irene Simmonds17Martyn Kennedy18Nazia Ahmed19Ann Cochrane20Mike Messenger21Puvanendran Tharmanathan2218 North Wales Centre for Primary Care Research, Bangor University, Wrexham, UKLeeds Cancer Centre, St James`s Institute of Oncology, Leeds Teaching Hospitals NHS Trust, Leeds, UKYork Clinical Trials Unit, The University of York, York, UKAcademic Unit of Lifespan and Population Health, University of Nottingham, Nottingham, UKRespiratory Medicine Unit, David Evans Research Centre, Nottingham University Hospitals NHS Trust, Nottingham, UK3 Department of Radiology, North Bristol NHS Trust, Bristol, UKDanish Center for Health Services Research, Department of Clinical Medicine, Aalborg University, Aalborg, Denmark1 Manchester Thoracic Oncology Centre, Wythenshawe Hospital, Manchester University NHS Foundation Trust, Manchester, UKUniversity of Hull, Hull, UKLungs for Living Research Centre, UCL Respiratory, University College London, London, UK1 Queen Mary University of London, London, UKCentre for Health Economics, University of York, Heslington, York, UKDepartment of Respiratory Medicine, Leeds Teaching Hospitals NHS Trust, Leeds, UK3 Department of Research and Innovation, Leeds Teaching Hospitals NHS Trust, Leeds, UK1 Wolfson Institute of Population Health, Queen Mary University, London, UKCentre for Health Economics, University of York, York, UKDivision of Infection, Immunity and Respiratory Medicine, The University of Manchester, Manchester, UK2 Leeds Institute of Health Sciences, University of Leeds, Leeds, UKLeeds Teaching Hospitals NHS Trust, Leeds, UKLeeds Institute of Health Sciences, University of Leeds, Leeds, UK1 Department of Health Sciences, University of York, York, UKUniversity of Leeds, Leeds, UKYork Trials Unit, Department of Health Sciences, University of York, York, UKIntroduction 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.https://bmjopen.bmj.com/content/10/9/e037075.full
spellingShingle Richard D Neal
Kevin Franks
David Torgerson
Rachael L Murray
David R Baldwin
Michael Darby
Henrik Moller
Richard Booton
Una MacLeod
Sam M Janes
Samantha L Quaife
Sebastian Hinde
Matthew EJ Callister
Suzanne Rogerson
Rhian Gabe
Mark Sculpher
Philip AJ Crosbie
Irene Simmonds
Martyn Kennedy
Nazia Ahmed
Ann Cochrane
Mike Messenger
Puvanendran Tharmanathan
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
BMJ Open
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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
url https://bmjopen.bmj.com/content/10/9/e037075.full
work_keys_str_mv AT richarddneal yorkshirelungscreeningtrialylstprotocolforarandomisedcontrolledtrialtoevaluateinvitationtocommunitybasedlowdosectscreeningforlungcancerversususualcareinatargetedpopulationatrisk
AT kevinfranks yorkshirelungscreeningtrialylstprotocolforarandomisedcontrolledtrialtoevaluateinvitationtocommunitybasedlowdosectscreeningforlungcancerversususualcareinatargetedpopulationatrisk
AT davidtorgerson yorkshirelungscreeningtrialylstprotocolforarandomisedcontrolledtrialtoevaluateinvitationtocommunitybasedlowdosectscreeningforlungcancerversususualcareinatargetedpopulationatrisk
AT rachaellmurray yorkshirelungscreeningtrialylstprotocolforarandomisedcontrolledtrialtoevaluateinvitationtocommunitybasedlowdosectscreeningforlungcancerversususualcareinatargetedpopulationatrisk
AT davidrbaldwin yorkshirelungscreeningtrialylstprotocolforarandomisedcontrolledtrialtoevaluateinvitationtocommunitybasedlowdosectscreeningforlungcancerversususualcareinatargetedpopulationatrisk
AT michaeldarby yorkshirelungscreeningtrialylstprotocolforarandomisedcontrolledtrialtoevaluateinvitationtocommunitybasedlowdosectscreeningforlungcancerversususualcareinatargetedpopulationatrisk
AT henrikmoller yorkshirelungscreeningtrialylstprotocolforarandomisedcontrolledtrialtoevaluateinvitationtocommunitybasedlowdosectscreeningforlungcancerversususualcareinatargetedpopulationatrisk
AT richardbooton yorkshirelungscreeningtrialylstprotocolforarandomisedcontrolledtrialtoevaluateinvitationtocommunitybasedlowdosectscreeningforlungcancerversususualcareinatargetedpopulationatrisk
AT unamacleod yorkshirelungscreeningtrialylstprotocolforarandomisedcontrolledtrialtoevaluateinvitationtocommunitybasedlowdosectscreeningforlungcancerversususualcareinatargetedpopulationatrisk
AT sammjanes yorkshirelungscreeningtrialylstprotocolforarandomisedcontrolledtrialtoevaluateinvitationtocommunitybasedlowdosectscreeningforlungcancerversususualcareinatargetedpopulationatrisk
AT samanthalquaife yorkshirelungscreeningtrialylstprotocolforarandomisedcontrolledtrialtoevaluateinvitationtocommunitybasedlowdosectscreeningforlungcancerversususualcareinatargetedpopulationatrisk
AT sebastianhinde yorkshirelungscreeningtrialylstprotocolforarandomisedcontrolledtrialtoevaluateinvitationtocommunitybasedlowdosectscreeningforlungcancerversususualcareinatargetedpopulationatrisk
AT matthewejcallister yorkshirelungscreeningtrialylstprotocolforarandomisedcontrolledtrialtoevaluateinvitationtocommunitybasedlowdosectscreeningforlungcancerversususualcareinatargetedpopulationatrisk
AT suzannerogerson yorkshirelungscreeningtrialylstprotocolforarandomisedcontrolledtrialtoevaluateinvitationtocommunitybasedlowdosectscreeningforlungcancerversususualcareinatargetedpopulationatrisk
AT rhiangabe yorkshirelungscreeningtrialylstprotocolforarandomisedcontrolledtrialtoevaluateinvitationtocommunitybasedlowdosectscreeningforlungcancerversususualcareinatargetedpopulationatrisk
AT marksculpher yorkshirelungscreeningtrialylstprotocolforarandomisedcontrolledtrialtoevaluateinvitationtocommunitybasedlowdosectscreeningforlungcancerversususualcareinatargetedpopulationatrisk
AT philipajcrosbie yorkshirelungscreeningtrialylstprotocolforarandomisedcontrolledtrialtoevaluateinvitationtocommunitybasedlowdosectscreeningforlungcancerversususualcareinatargetedpopulationatrisk
AT irenesimmonds yorkshirelungscreeningtrialylstprotocolforarandomisedcontrolledtrialtoevaluateinvitationtocommunitybasedlowdosectscreeningforlungcancerversususualcareinatargetedpopulationatrisk
AT martynkennedy yorkshirelungscreeningtrialylstprotocolforarandomisedcontrolledtrialtoevaluateinvitationtocommunitybasedlowdosectscreeningforlungcancerversususualcareinatargetedpopulationatrisk
AT naziaahmed yorkshirelungscreeningtrialylstprotocolforarandomisedcontrolledtrialtoevaluateinvitationtocommunitybasedlowdosectscreeningforlungcancerversususualcareinatargetedpopulationatrisk
AT anncochrane yorkshirelungscreeningtrialylstprotocolforarandomisedcontrolledtrialtoevaluateinvitationtocommunitybasedlowdosectscreeningforlungcancerversususualcareinatargetedpopulationatrisk
AT mikemessenger yorkshirelungscreeningtrialylstprotocolforarandomisedcontrolledtrialtoevaluateinvitationtocommunitybasedlowdosectscreeningforlungcancerversususualcareinatargetedpopulationatrisk
AT puvanendrantharmanathan yorkshirelungscreeningtrialylstprotocolforarandomisedcontrolledtrialtoevaluateinvitationtocommunitybasedlowdosectscreeningforlungcancerversususualcareinatargetedpopulationatrisk