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

Philip Aj Crosbie, Rhian Gabe, Irene Simmonds, Martyn Kennedy, Suzanne Rogerson, Nazia Ahmed, David R Baldwin, Richard Booton, Ann Cochrane, Michael Darby, Kevin Franks, Sebastian Hinde, Sam M Janes, Una Macleod, Mike Messenger, Henrik Moller, Rachael L Murray, Richard D Neal, Samantha L Quaife, Mark Sculpher, Puvanendran Tharmanathan, David Torgerson, Matthew Ej Callister, Philip Aj Crosbie, Rhian Gabe, Irene Simmonds, Martyn Kennedy, Suzanne Rogerson, Nazia Ahmed, David R Baldwin, Richard Booton, Ann Cochrane, Michael Darby, Kevin Franks, Sebastian Hinde, Sam M Janes, Una Macleod, Mike Messenger, Henrik Moller, Rachael L Murray, Richard D Neal, Samantha L Quaife, Mark Sculpher, Puvanendran Tharmanathan, David Torgerson, Matthew Ej Callister

Abstract

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.

Keywords: chest imaging; respiratory tract tumours.

Conflict of interest statement

Competing interests: PAJC has received consultation fees and shares options from Everest Detection. PAJC is supported by the NIHR Manchester Biomedical Research Centre.

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ.

Figures

Figure 1
Figure 1
YLST flow diagram. GP, general practice; LDCT, low-dose computed tomography; LHC, Lung Health Check, LLP, Liverpool Lung Project; PLCO, Prostate, Lung, Colorectal and Ovarian; USPSTF, US Preventive Services Task Force; YESS, Yorkshire Enhanced Stop Smoking; YLST, Yorkshire Lung Screening Trial.
Figure 2
Figure 2
Management algorithms for (A) solid pulmonary nodules detected in the first screening round (T0); (B) solid nodules detected in an incidence round (T2) and (C) subsolid nodules detected during screening. CTgBx, CT-guided percutaneous biopsy; LTH, Leeds Teaching Hospitals; MDT, lung cancer multidisciplinary team meeting; PET, positron emission tomography; pGGN, pure ground glass nodule; PSN, part solid nodule; VDT, volume doubling time.

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