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

doi:10.1136/bmjopen-2020-037075

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.

Highlights

Lung cancer is the world’s leading cause of cancer death
In 2014, the US Preventive Services Task Force (USPSTF) recommended Low-dose computed tomography (LDCT) screening for lung cancer based on the National Lung Screening Trial (NLST) findings, extending the upper age to 80 years.[4 5]
Age 55–80, are randomised to either invitation to a telephone assessment followed by a community-based Lung Health Check (LHC) if at high risk or usual care

Summary

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. Low-dose computed tomography (LDCT) screening reduced mortality in the US National Lung Screening Trial (NLST), which randomised 53 439 participants at high risk to annual LDCT or chest X-r ay screening for 2 years.[1] LDCT screening reduced lung cancer specific and all-cause mortality by 20% and 6.7%, respectively. This finding has recently been confirmed by the Nederlands- Leuvens Longkanker Screenings Onderzoek. Despite on-going implementation in the USA, several important issues remain unresolved, including optimising identification of high-risk individuals for screening, embedding smoking cessation in screening programmes and improving uptake in those at highest risk.[6]

Objectives

Methods

Findings

Conclusion