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Assessment of the EarlyCDT-Lung test as an early biomarker of lung cancer in ever-smokers: A retrospective nested case-control study in two prospective cohorts
Umeå University, Faculty of Medicine, Department of Radiation Sciences, Oncology.ORCID iD: 0000-0002-6169-5155
Umeå University, Faculty of Medicine, Department of Radiation Sciences, Oncology.ORCID iD: 0000-0002-0759-3932
Genomic Epidemiology Branch, International Agency for Research on Cancer, Lyon, France.
Department of Epidemiology and Biostatistics, School of Public Health, Imperial College London, London, United Kingdom.
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2023 (English)In: International Journal of Cancer, ISSN 0020-7136, E-ISSN 1097-0215, Vol. 152, no 9, p. 2002-2010Article in journal (Refereed) Published
Abstract [en]

The EarlyCDT-Lung test is a blood-based autoantibody assay intended to identify high-risk individuals for low-dose computed tomography lung cancer screening. However, there is a paucity of evidence on the performance of the EarlyCDT-Lung test in ever-smokers. We conducted a nested case-control study within two prospective cohorts to evaluate the risk-discriminatory performance of the EarlyCDT-Lung test using prediagnostic blood samples from 154 future lung cancer cases and 154 matched controls. Cases were selected from those who had ever smoked and had a prediagnostic blood sample <3 years prior to diagnosis. Conditional logistic regression was used to estimate the association between EarlyCDT-Lung test results and lung cancer risk. Sensitivity and specificity of the EarlyCDT-Lung test were calculated in all subjects and subgroups based on age, smoking history, lung cancer stage, sample collection time before diagnosis and year of sample collection. The overall lung cancer odds ratios were 0.89 (95% CI: 0.34-2.30) for a moderate risk EarlyCDT-Lung test result and 1.09 (95% CI: 0.48-2.47) for a high-risk test result compared to no significant test result. The overall sensitivity was 8.4% (95% CI: 4.6-14) and overall specificity was 92% (95% CI: 87-96) when considering a high-risk result as positive. Stratified analysis indicated higher sensitivity (17%, 95% CI: 7.2-32.1) in subjects with blood drawn up to 1 year prior to diagnosis. In conclusion, our study does not support a role of the EarlyCDT-Lung test in identifying the high-risk subjects in ever-smokers for lung cancer screening in the EPIC and NSHDS cohorts.

Place, publisher, year, edition, pages
John Wiley & Sons, 2023. Vol. 152, no 9, p. 2002-2010
Keywords [en]
biomarkers, EarlyCDT-Lung test, lung cancer, prediagnostic samples
National Category
Cancer and Oncology
Identifiers
URN: urn:nbn:se:umu:diva-201192DOI: 10.1002/ijc.34340ISI: 000879090900001PubMedID: 36305647Scopus ID: 2-s2.0-85141537278OAI: oai:DiVA.org:umu-201192DiVA, id: diva2:1724110
Funder
Cancerforskningsfonden i Norrland, AMP19-962Swedish Cancer SocietySwedish Research Council, 2017-00650Available from: 2023-01-05 Created: 2023-01-05 Last updated: 2023-06-19Bibliographically approved

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Wu, Wendy Yi-YingHaider, ZahraMelin, Beatrice S.Johansson, Mikael

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