Detection in blood of autoantibodies to tumour antigens as a case-finding method in lung cancer using the EarlyCDT®-Lung Test (ECLS): study protocol for a randomized controlled trial

BMC Cancer

Study Protocol

Stephanie Gallant¹  Alistair Dorward²  Stuart Schembri³  Chris Robertson⁴  Herb Sewell⁵  Frances S. Mair⁶  F. M. Sullivan⁷  John Robertson⁸  Andrew Briggs⁹  Shaun Treweek^1,10  Colin McCowan^1,11  Kavita Vedhara^1,12  Denise Kendrick^1,12  Laura Bedford^1,13  Ben Young^1,13  Cathy Jackson^1,14  Eoghan Farmer^1,15  Roberta Littleford^1,16  Joseph Sarvesvaran^1,17 

[1] Clinical Trial Manager, Tayside Clinical Trials Unit, University of Dundee, Dundee, UK;Consultant Physician, NHS Greater Glasgow & Clyde, Glasgow, UK;Consultant Respiratory Physician, Ninewells Hospital, Dundee, UK;Department of Mathematics and Statistics, Livingstone Tower, 26 Richmond Street, G1 1XH, Glasgow, UK;Division of Immunology, School of Life Sciences, Queens Medical Centre, Nottingham, UK;General Practice and Primary Care, Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK;Gordon F. Cheesbrough Research Chair & Director of UTOPIAN, Department of Family and Community Medicine University of Toronto, North York General Hospital, 4001 Leslie St LE140, M2K 1E1, Toronto, ON, Canada;Graduate Entry Medicine & Health School (GEMS), University of Nottingham, Royal Derby Hospital, Nottingham, UK;Health Economics & Health Technology Assessment, Institute of Health & Wellbeing, University of Glasgow, Glasgow, UK;Health Services Research Unit, University of Aberdeen, Aberdeen, UK;Robertson Centre for Biostatistics, University of Glasgow, Glasgow, UK;School of Medicine, Division of Primary Care, Floor 13, Tower Building, University Park, Nottingham, UK;School of Medicine, Division of Primary Care, Medical School, Queen’s Medical Centre, Nottingham, UK;School of Medicine, University of Central Lancashire, Preston, UK;School of Medicine,, St Andrews University, St Andrews, UK;Senior Clinical Trial Manager, Tayside Clinical Trials Unit, University of Dundee, Dundee, UK;The Queen Elizabeth University Hospital Glasgow, 1345 Govan Road, G51 4TF, Glasgow, UK;

关键词: Lung cancer;    Early diagnosis;    Screening;    Health economics;    RCT;    Primary care;    Biomarker;    Autoantibodies;   

DOI  :  10.1186/s12885-017-3175-y

 received in 2015-12-17, accepted in 2017-03-04,  发布年份 2017

来源: Springer

【 摘 要 】

BackgroundLung cancer is the most common cause of cancer related death worldwide. The majority of cases are detected at a late stage when prognosis is poor. The EarlyCDT®-Lung Test detects autoantibodies to abnormal cell surface proteins in the earliest stages of the disease which may allow tumour detection at an earlier stage thus altering prognosis.The primary research question is: Does using the EarlyCDT®-Lung Test to identify those at high risk of lung cancer, followed by X-ray and computed tomography (CT) scanning, reduce the incidence of patients with late-stage lung cancer (III & IV) or unclassified presentation (U) at diagnosis, compared to standard practice?MethodsA randomised controlled trial of 12 000 participants in areas of Scotland targeting general practices serving patients in the most deprived quintile of the Scottish Index of Multiple Deprivation. Adults aged 50–75 who are at high risk of lung cancer and healthy enough to undergo potentially curative therapy (Performance Status 0–2) are eligible to participate. The intervention is the EarlyCDT®-Lung Test, followed by X-ray and CT in those with a positive result. The comparator is standard clinical practice in the UK. The primary outcome is the difference, after 24 months, between the rates of patients with stage III, IV or unclassified lung cancer at diagnosis. The secondary outcomes include: all-cause mortality; disease specific mortality; a range of morbidity outcomes; cost-effectiveness and measures examining the psychological and behavioural consequences of screening.Participants with a positive test result but for whom the CT scan does not lead to a lung cancer diagnosis will be offered 6 monthly thoracic CTs for 24 months. An initial chest X-ray will be used to determine the speed and the need for contrast in the first screening CT. Participants who are found to have lung cancer will be followed-up to assess both time to diagnosis and stage of disease at diagnosis.DiscussionThe study will determine the clinical and cost effectiveness of EarlyCDT®-Lung Test for early lung cancer detection and assess its suitability for a large-scale, accredited screening service. The study will also assess the potential psychological and behavioural harms arising from false positive or false negative results, as well as the potential benefits to patients of true negative EarlyCDT lung test results. A cost-effectiveness model of lung cancer screening based on the results of the EarlyCDT Lung Test study will be developed.Trial registrationNCT01925625. August 19, 2013

【 授权许可】

CC BY   
© The Author(s). 2017