{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,16]],"date-time":"2026-09-16T19:46:55Z","timestamp":1789588015589,"version":"build-2803163510"},"reference-count":37,"publisher":"European Respiratory Society (ERS)","license":[{"start":{"date-parts":[[2020,7,30]],"date-time":"2020-07-30T00:00:00Z","timestamp":1596067200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Oncimmune Ltd."},{"DOI":"10.13039\/100011529","name":"Scottish Government Health and Social Care Directorate","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100011529","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["ersjournals.com"],"crossmark-restriction":true},"short-container-title":["Eur Respir J"],"abstract":"<jats:p>The EarlyCDT-Lung test is a high specificity blood-based autoantibody biomarker that could contribute to predicting lung cancer risk. Here we report on the results of a phase IV biomarker evaluation of whether using the EarlyCDT-Lung test and any subsequent CT scanning to identify those at high risk of lung cancer reduces the incidence of patients with stage III\/IV\/Unspecified lung cancer at diagnosis, compared with the standard clinical practice at the time the study began.<\/jats:p><jats:p>ECLS was a randomised controlled trial of 12\u200a208 participants at risk of developing lung cancer in Scotland. The intervention arm received the EarlyCDT-Lung test and, if test positive, low-dose CT scanning six-monthly for up to 2\u2005years. EarlyCDT-Lung test negative and control arm participants received standard clinical care. Outcomes were assessed at 2\u2005years post-randomisation using validated data on cancer occurrence, cancer staging, mortality and comorbidities.<\/jats:p><jats:p>At 2\u2005years, 127 lung cancers were detected in the study population (1.0%).<\/jats:p><jats:p>In the intervention arm, 33\/56 (58.9%) lung cancers were diagnosed at stage III\/IV compared to 52\/71 (73.2%) in the control arm. The hazard ratio for stage III\/IV presentation was 0.64 (95% confidence interval 0.41, 0.99). There were non-significant differences in lung cancer and all-cause mortality after 2\u2005years.<\/jats:p><jats:p>ECLS compared EarlyCDT-Lung plus CT screening to standard clinical care (symptomatic presentation), and was not designed to assess the incremental contribution of the EarlyCDT-Lung test. The observation of a stage-shift towards earlier-stage lung cancer diagnosis merits further investigations to evaluate whether the EarlyCDT-Lung test adds anything to the emerging standard of LDCT.<\/jats:p>","DOI":"10.1183\/13993003.00670-2020","type":"journal-article","created":{"date-parts":[[2020,7,30]],"date-time":"2020-07-30T19:39:39Z","timestamp":1596137979000},"page":"2000670","update-policy":"https:\/\/doi.org\/10.1183\/ers-crossmark-policy","source":"Crossref","is-referenced-by-count":63,"title":["Earlier diagnosis of lung cancer in a randomised trial of an autoantibody blood test followed by imaging"],"prefix":"10.1183","author":[{"given":"Frank M.","family":"Sullivan","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Frances S.","family":"Mair","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"William","family":"Anderson","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pauline","family":"Armory","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrew","family":"Briggs","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cindy","family":"Chew","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alistair","family":"Dorward","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John","family":"Haughney","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fiona","family":"Hogarth","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Denise","family":"Kendrick","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Roberta","family":"Littleford","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alex","family":"McConnachie","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Colin","family":"McCowan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nicola","family":"Mcmeekin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Manish","family":"Patel","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Petra","family":"Rauchhaus","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lewis","family":"Ritchie","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chris","family":"Robertson","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John","family":"Robertson","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jose","family":"Robles-Zurita","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joseph","family":"Sarvesvaran","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Herbert","family":"Sewell","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Sproule","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas","family":"Taylor","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Agnes","family":"Tello","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shaun","family":"Treweek","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9940-7534","authenticated-orcid":false,"given":"Kavita","family":"Vedhara","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stuart","family":"Schembri","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"The Early Diagnosis of Lung Cancer Scotland (ECLS) Team","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"81","published-online":{"date-parts":[[2020,7,30]]},"reference":[{"key":"2021011401300479000_57.1.2000670.1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(17)33326-3"},{"key":"2021011401300479000_57.1.2000670.2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1102873"},{"key":"2021011401300479000_57.1.2000670.3","doi-asserted-by":"crossref","first-page":"1732","DOI":"10.1016\/j.jtho.2019.05.044","article-title":"Lung cancer incidence and mortality with extended follow-up in the National Lung Screening Trial","volume":"14","year":"2019","journal-title":"J Thorac Oncol"},{"key":"2021011401300479000_57.1.2000670.4","doi-asserted-by":"crossref","first-page":"503","DOI":"10.1056\/NEJMoa1911793","article-title":"Reduced lung-cancer mortality with volume CT screening in a randomized trial","volume":"382","author":"de Koning","year":"2020","journal-title":"N Engl J Med"},{"key":"2021011401300479000_57.1.2000670.5","first-page":"1162","article-title":"Long-term follow-up results of the DANTE trial, a randomized study of lung cancer screening with spiral computed tomography","volume":"30","author":"Infante","year":"2019","journal-title":"Ann Oncol"},{"key":"2021011401300479000_57.1.2000670.6","doi-asserted-by":"crossref","first-page":"1162","DOI":"10.1093\/annonc\/mdz117","article-title":"Prolonged lung cancer screening reduced 10-year mortality in the MILD trial","volume":"30","author":"Pastorino","year":"2019","journal-title":"Ann Oncol"},{"key":"2021011401300479000_57.1.2000670.7","doi-asserted-by":"crossref","first-page":"126","DOI":"10.1186\/s12890-019-0883-x","article-title":"Effects of low-dose computed tomography on lung cancer screening: a systematic review, meta-analysis, and trial sequential analysis","volume":"19","author":"Huang","year":"2019","journal-title":"BMC Pulm Med"},{"key":"2021011401300479000_57.1.2000670.8","first-page":"1503","article-title":"Lung cancer mortality reduction by LDCT screening \u2013 results from the randomized German LUSI trial","volume":"1513","author":"Becker","year":"2019","journal-title":"Int J Cancer"},{"key":"2021011401300479000_57.1.2000670.9","doi-asserted-by":"publisher","DOI":"10.1164\/rccm.201505-1040OC"},{"key":"2021011401300479000_57.1.2000670.10","doi-asserted-by":"crossref","first-page":"65","DOI":"10.1097\/RTI.0000000000000367","article-title":"An update on the European lung cancer screening trials and comparison of lung cancer screening recommendations in Europe","volume":"34","author":"Han","year":"2019","journal-title":"J Thorac Imaging"},{"key":"2021011401300479000_57.1.2000670.11"},{"key":"2021011401300479000_57.1.2000670.12","doi-asserted-by":"publisher","DOI":"10.1002\/ijc.20715"},{"key":"2021011401300479000_57.1.2000670.13","doi-asserted-by":"crossref","first-page":"549","DOI":"10.1200\/jco.2005.23.16_suppl.549","article-title":"Autoantibodies in early breast cancer","volume":"23","author":"Robertson","year":"2005","journal-title":"J Clin Oncol"},{"key":"2021011401300479000_57.1.2000670.14","doi-asserted-by":"crossref","first-page":"1319","DOI":"10.1007\/s13277-012-0379-2","article-title":"EarlyCDT-Lung test: improved clinical utility through additional autoantibody assays","volume":"33","author":"Chapman","year":"2012","journal-title":"Tumor Biol"},{"key":"2021011401300479000_57.1.2000670.15","doi-asserted-by":"publisher","DOI":"10.1016\/j.lungcan.2013.10.008"},{"key":"2021011401300479000_57.1.2000670.16","doi-asserted-by":"crossref","first-page":"187","DOI":"10.1186\/s12885-017-3175-y","article-title":"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","volume":"17","author":"Sullivan","year":"2017","journal-title":"BMC Cancer"},{"key":"2021011401300479000_57.1.2000670.17","unstructured":"Health Research Authority . UK Policy Framework for Health and Social Care Research. 2017. www.hra.nhs.uk\/planning-and-improving-research\/policies-standards-legislation\/uk-policy-framework-health-social-care-research Date last accessed: September 26, 2019."},{"key":"2021011401300479000_57.1.2000670.18","doi-asserted-by":"publisher","DOI":"10.1038\/bjc.2012.68"},{"key":"2021011401300479000_57.1.2000670.19","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.c332"},{"key":"2021011401300479000_57.1.2000670.20","doi-asserted-by":"publisher","DOI":"10.1148\/radiol.2017161659"},{"key":"2021011401300479000_57.1.2000670.21","unstructured":"National Institute for Health and Care Excellence . Suspected Cancer: Recognition and Referral. NICE Guideline NG12. London, NICE, 2015."},{"key":"2021011401300479000_57.1.2000670.22","doi-asserted-by":"crossref","first-page":"1276","DOI":"10.1186\/s12889-018-6211-1","article-title":"Determinants of motivation to quit in smokers screened for the early detection of lung cancer: a qualitative study","volume":"18","author":"Young","year":"2018","journal-title":"BMC Public Health"},{"key":"2021011401300479000_57.1.2000670.23","doi-asserted-by":"crossref","first-page":"160","DOI":"10.1016\/j.lungcan.2018.08.001","article-title":"Lung cancer CT screening: psychological responses in the presence and absence of pulmonary nodules","volume":"124","author":"Clark","year":"2018","journal-title":"Lung Cancer"},{"key":"2021011401300479000_57.1.2000670.24","unstructured":"Information Services Division Scotland . Scottish Cancer Registry (SMR06). 2019. www.ndc.scot.nhs.uk\/National-Datasets\/data.asp?SubID=8 Date last accessed: November19, 2019."},{"key":"2021011401300479000_57.1.2000670.25","unstructured":"World Health Organization . International Classification of Diseases for Oncology, 3rd Edition (ICD-O-3). 2015. www.who.int\/classifications\/icd\/adaptations\/oncology\/en Date last accessed: July 23, 2019."},{"key":"2021011401300479000_57.1.2000670.26","doi-asserted-by":"publisher","DOI":"10.1148\/radiol.2351041662"},{"key":"2021011401300479000_57.1.2000670.27","doi-asserted-by":"crossref","first-page":"e89513","DOI":"10.1371\/journal.pone.0089513","article-title":"Association between socioeconomic factors and cancer risk: a population cohort study in Scotland (1991\u20132006)","volume":"9","author":"Sharpe","year":"2014","journal-title":"PLoS One"},{"key":"2021011401300479000_57.1.2000670.28","doi-asserted-by":"crossref","first-page":"399","DOI":"10.1001\/jamainternmed.2016.9022","article-title":"Implementation of lung cancer screening in the Veterans Health Administration","volume":"177","author":"Kinsinger","year":"2017","journal-title":"JAMA Intern Med"},{"key":"2021011401300479000_57.1.2000670.29","doi-asserted-by":"publisher","DOI":"10.1093\/aje\/kwk075"},{"key":"2021011401300479000_57.1.2000670.30","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1211776"},{"key":"2021011401300479000_57.1.2000670.31","doi-asserted-by":"publisher","DOI":"10.1136\/thoraxjnl-2017-211107"},{"key":"2021011401300479000_57.1.2000670.32","doi-asserted-by":"crossref","first-page":"958","DOI":"10.1111\/bjhp.12265","article-title":"Do negative screening test results cause false reassurance? A systematic review","volume":"22","author":"Cooper","year":"2017","journal-title":"Br J Health Psychol"},{"key":"2021011401300479000_57.1.2000670.33","doi-asserted-by":"crossref","first-page":"e0197826","DOI":"10.1371\/journal.pone.0197826","article-title":"Cost-effectiveness of an autoantibody test (EarlyCDT-Lung) as an aid to early diagnosis of lung cancer in patients with incidentally detected pulmonary nodules","volume":"13","author":"Edelsberg","year":"2018","journal-title":"PLoS One"},{"key":"2021011401300479000_57.1.2000670.34","doi-asserted-by":"crossref","first-page":"477","DOI":"10.1016\/j.autrev.2016.01.017","article-title":"Autoantibody production in cancer \u2013 the humoral immune response toward autologous antigens in cancer patients","volume":"15","author":"Zaenker","year":"2016","journal-title":"Autoimmun Rev"},{"key":"2021011401300479000_57.1.2000670.35","doi-asserted-by":"crossref","first-page":"578","DOI":"10.1016\/j.jtho.2016.08.143","article-title":"Autoantibody signature enhances the positive predictive power of computed tomography and nodule-based risk models for detection of lung cancer","volume":"12","author":"Massion","year":"2017","journal-title":"J Thorac Oncol"},{"key":"2021011401300479000_57.1.2000670.36","doi-asserted-by":"publisher","DOI":"10.1038\/s41586-019-1799-6"},{"key":"2021011401300479000_57.1.2000670.37","doi-asserted-by":"crossref","first-page":"25","DOI":"10.1016\/j.lungcan.2019.05.028","article-title":"CT screening for lung cancer: are we ready to implement in Europe?","volume":"134","author":"Balata","year":"2019","journal-title":"Lung Cancer"}],"container-title":["European Respiratory Journal"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1183\/13993003.00670-2020","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,2,24]],"date-time":"2025-02-24T07:36:00Z","timestamp":1740382560000},"score":1,"resource":{"primary":{"URL":"https:\/\/publications.ersnet.org\/lookup\/doi\/10.1183\/13993003.00670-2020"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,7,30]]},"references-count":37,"alternative-id":["10.1183\/13993003.00670-2020"],"URL":"https:\/\/doi.org\/10.1183\/13993003.00670-2020","relation":{},"ISSN":["0903-1936","1399-3003"],"issn-type":[{"value":"0903-1936","type":"print"},{"value":"1399-3003","type":"electronic"}],"subject":[],"published":{"date-parts":[[2020,7,30]]}}}