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
Open Access
- 10 September 2020
- Vol. 10 (9), e037075
- https://doi.org/10.1136/bmjopen-2020-037075
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
Funding Information
- Yorkshire Cancer Research (L403 & L403B)
This publication has 49 references indexed in Scilit:
- Probability of Cancer in Pulmonary Nodules Detected on First Screening CTThe New England Journal of Medicine, 2013
- Characteristics of Lung Cancers Detected by Computer Tomography Screening in the Randomized NELSON TrialAmerican Journal of Respiratory and Critical Care Medicine, 2013
- Applying the National Lung Screening Trial eligibility criteria to the US population: what percent of the population and of incident lung cancers would be covered?Journal of Medical Screening, 2012
- The distribution of lung cancer across sectors of society in the United Kingdom: a study using national primary care dataBMC Public Health, 2011
- Primary care endorsement letter and a patient leaflet to improve participation in colorectal cancer screening: results of a factorial randomised trialBritish Journal of Cancer, 2011
- Reduced Lung-Cancer Mortality with Low-Dose Computed Tomographic ScreeningThe New England Journal of Medicine, 2011
- Inequalities in participation in an organized national colorectal cancer screening programme: results from the first 2.6 million invitations in EnglandInternational Journal of Epidemiology, 2011
- A 12-Item Short-Form Health SurveyMedical Care, 1996
- EuroQol - a new facility for the measurement of health-related quality of lifeHealth Policy, 1990
- A New Design for Randomized Clinical TrialsThe New England Journal of Medicine, 1979