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dc.contributor.authorSullivan, F. M.
dc.contributor.authorFarmer, Eoghan
dc.contributor.authorMair, Frances S.
dc.contributor.authorTreweek, Shaun
dc.contributor.authorKendrick, Denise
dc.contributor.authorJackson, Cathy
dc.contributor.authorRobertson, Chris
dc.contributor.authorBriggs, Andrew
dc.contributor.authorMcCowan, Colin
dc.contributor.authorBedford, Laura
dc.contributor.authorYoung, Ben
dc.contributor.authorVedhara, Kavita
dc.contributor.authorGallant, Stephanie
dc.contributor.authorLittleford, Roberta
dc.contributor.authorRobertson, John
dc.contributor.authorSewell, Herb
dc.contributor.authorDorward, Alistair
dc.contributor.authorSarvesvaran, Joseph
dc.contributor.authorSchembri, Stuart
dc.date.accessioned2017-03-13T17:30:10Z
dc.date.available2017-03-13T17:30:10Z
dc.date.issued2017-03-11
dc.identifier.citationSullivan , F M , Farmer , E , Mair , F S , Treweek , S , Kendrick , D , Jackson , C , Robertson , C , Briggs , A , McCowan , C , Bedford , L , Young , B , Vedhara , K , Gallant , S , Littleford , R , Robertson , J , Sewell , H , Dorward , A , Sarvesvaran , J & 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 , vol. 17 , no. 1 , 187 . https://doi.org/10.1186/s12885-017-3175-yen
dc.identifier.issn1471-2407
dc.identifier.otherPURE: 249366658
dc.identifier.otherPURE UUID: cc9e8c48-6734-43be-814e-624a3f7e6fa5
dc.identifier.otherRIS: Sullivan2017
dc.identifier.otherScopus: 85014881385
dc.identifier.otherWOS: 000397775400002
dc.identifier.otherORCID: /0000-0002-6623-4964/work/33508475
dc.identifier.urihttps://hdl.handle.net/10023/10460
dc.descriptionFunding for the study was provided by the Chief Scientist Office, Scottish Government and Oncimmune Ltd.en
dc.description.abstractBackground: 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.
dc.format.extent10
dc.language.isoeng
dc.relation.ispartofBMC Canceren
dc.rights© The Author(s). 2017 Open Access. This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.en
dc.subjectLung canceren
dc.subjectEarly diagnosisen
dc.subjectScreeningen
dc.subjectHealth economicsen
dc.subjectRCTen
dc.subjectPrimary careen
dc.subjectBiomarkeren
dc.subjectAutoantibodiesen
dc.subjectRC0254 Neoplasms. Tumors. Oncology (including Cancer)en
dc.subjectOncologyen
dc.subjectGeneticsen
dc.subjectCancer Researchen
dc.subjectT-DASen
dc.subjectSDG 3 - Good Health and Well-beingen
dc.subject.lccRC0254en
dc.titleDetection 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 trialen
dc.typeJournal articleen
dc.description.versionPublisher PDFen
dc.contributor.institutionUniversity of St Andrews. School of Medicineen
dc.contributor.institutionUniversity of St Andrews. Population and Behavioural Science Divisionen
dc.identifier.doihttps://doi.org/10.1186/s12885-017-3175-y
dc.description.statusPeer revieweden
dc.identifier.urlhttp://www.scopus.com/inward/record.url?scp=85014881385&partnerID=8YFLogxKen


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