TY - JOUR
T1 - Yorkshire Lung Screening Trial (YLST)
T2 - 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
AU - Crosbie, Philip A.J.
AU - Gabe, Rhian
AU - Simmonds, Irene
AU - Kennedy, Martyn
AU - Rogerson, Suzanne
AU - Ahmed, Nazia
AU - Baldwin, David R.
AU - Booton, Richard
AU - Cochrane, Ann
AU - Darby, Michael
AU - Franks, Kevin
AU - Hinde, Sebastian
AU - Janes, Sam M.
AU - MacLeod, Una
AU - Messenger, Mike
AU - Moller, Henrik
AU - Murray, Rachael L.
AU - Neal, Richard D.
AU - Quaife, Samantha L.
AU - Sculpher, Mark
AU - Tharmanathan, Puvanendran
AU - Torgerson, David
AU - Callister, Matthew E.J.
N1 - Funding Information:
This work was funded by the Yorkshire Cancer Research (Award references L403 & L403B).
Funding Information:
PAJC has received consultation fees and shares options from Everest Detection. PAJC is supported by the NIHR Manchester Biomedical Research Centre.
Publisher Copyright:
©
PY - 2020/9/10
Y1 - 2020/9/10
N2 - 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. zMethods 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 PLCO M2012 (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.
AB - 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. zMethods 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 PLCO M2012 (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.
KW - chest imaging
KW - respiratory tract tumours
UR - http://www.scopus.com/inward/record.url?scp=85090818818&partnerID=8YFLogxK
U2 - 10.1136/bmjopen-2020-037075
DO - 10.1136/bmjopen-2020-037075
M3 - Article
C2 - 32912947
AN - SCOPUS:85090818818
SN - 2044-6055
VL - 10
SP - 1
EP - 10
JO - BMJ Open
JF - BMJ Open
IS - 9
M1 - e037075
ER -
