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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

Sullivan, F.M.; Farmer, Eoghan; Mair, Frances S.; Treweek, Shaun; Kendrick, Denise; Jackson, Cathy; Robertson, Chris; Briggs, Andrew; McCowan, Colin; Bedford, Laura; Young, Ben; Vedhara, Kavita; Gallant, Stephanie; Littleford, Roberta; Robertson, John; Sewell, Herb; Dorward, Alistair; Sarvesvaran, Joseph; Schembri, Stuart

Authors

F.M. Sullivan

Eoghan Farmer

Frances S. Mair

Shaun Treweek

Denise Kendrick

Cathy Jackson

Chris Robertson

Andrew Briggs

Colin McCowan

Laura Bedford

Ben Young

Kavita Vedhara

Stephanie Gallant

Roberta Littleford

John Robertson

Herb Sewell

Alistair Dorward

Joseph Sarvesvaran

Stuart Schembri



Abstract

Background: Lung 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?
Methods: A 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.
Discussion: The 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 registration: NCT01925625. August 19, 2013

Journal Article Type Article
Publication Date Mar 11, 2017
Journal BMC Cancer
Electronic ISSN 1471-2407
Publisher Springer Verlag
Peer Reviewed Peer Reviewed
Volume 17
Issue 1
APA6 Citation Sullivan, F., Farmer, E., Mair, F. S., Treweek, S., Kendrick, D., Jackson, C., …Schembri, S. (2017). 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, 17(1), https://doi.org/10.1186/s12885-017-3175-y
DOI https://doi.org/10.1186/s12885-017-3175-y
Keywords Lung cancer; Early diagnosis; Screening; Health economics; RCT; Primary care; Biomarker; Autoantibodies
Publisher URL http://bmccancer.biomedcentral.com/articles/10.1186/s12885-017-3175-y
Copyright Statement Copyright information regarding this work can be found at the following address: http://creativecommons.org/licenses/by/4.0

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Copyright Statement
Copyright information regarding this work can be found at the following address: http://creativecommons.org/licenses/by/4.0





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