1. 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
- Author
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Samantha L Quaife, Michael Darby, Matthew E.J. Callister, Rhian Gabe, Mike Messenger, Henrik Møller, Nazia Ahmed, Richard D Neal, Mark Sculpher, Kevin Franks, Una Macleod, Irene Simmonds, Suzanne Rogerson, Philip A.J. Crosbie, Richard Booton, Ann Cochrane, Puvanendran Tharmanathan, Sam M. Janes, David J. Torgerson, Martyn P.T. Kennedy, Rachael L Murray, Sebastian Hinde, and David R Baldwin
- Subjects
medicine.medical_specialty ,Lung Neoplasms ,medicine.medical_treatment ,Population ,law.invention ,Randomized controlled trial ,Quality of life ,law ,Risk Factors ,medicine ,Humans ,education ,Lung cancer ,Respiratory Medicine ,Lung ,Early Detection of Cancer ,Aged ,Randomized Controlled Trials as Topic ,Aged, 80 and over ,education.field_of_study ,Research ethics ,Health economics ,respiratory tract tumours ,business.industry ,General Medicine ,Middle Aged ,medicine.disease ,Family medicine ,Quality of Life ,Medicine ,Smoking cessation ,National Lung Screening Trial ,chest imaging ,business ,Tomography, X-Ray Computed - 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 numbersISRCTN42704678andNCT03750110.
- Published
- 2020