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dc.contributor.authorFunston, G
dc.contributor.authorHamilton, W
dc.contributor.authorAbel, G
dc.contributor.authorCrosbie, EJ
dc.contributor.authorRous, B
dc.contributor.authorWalter, FM
dc.date.accessioned2020-11-03T13:45:23Z
dc.date.issued2020-10-28
dc.description.abstractBACKGROUND: The serum biomarker cancer antigen 125 (CA125) is widely used as an investigation for possible ovarian cancer in symptomatic women presenting to primary care. However, its diagnostic performance in this setting is unknown. We evaluated the performance of CA125 in primary care for the detection of ovarian and non-ovarian cancers. METHODS AND FINDINGS: We studied women in the United Kingdom Clinical Practice Research Datalink with a CA125 test performed between 1 May 2011-31 December 2014. Ovarian and non-ovarian cancers diagnosed in the year following CA125 testing were identified from the cancer registry. Women were categorized by age: <50 years and ≥50 years. Conventional measures of test diagnostic accuracy, including sensitivity, specificity, and positive predictive value, were calculated for the standard CA125 cut-off (≥35 U/ml). The probability of a woman having cancer at each CA125 level between 1-1,000 U/ml was estimated using logistic regression. Cancer probability was also estimated on the basis of CA125 level and age in years using logistic regression. We identified CA125 levels equating to a 3% estimated cancer probability: the "risk threshold" at which the UK National Institute for Health and Care Excellence advocates urgent specialist cancer investigation. A total of 50,780 women underwent CA125 testing; 456 (0.9%) were diagnosed with ovarian cancer and 1,321 (2.6%) with non-ovarian cancer. Of women with a CA125 level ≥35 U/ml, 3.4% aged <50 years and 15.2% aged ≥50 years had ovarian cancer. Of women with a CA125 level ≥35 U/ml who were aged ≥50 years and who did not have ovarian cancer, 20.4% were diagnosed with a non-ovarian cancer. A CA125 value of 53 U/ml equated to a 3% probability of ovarian cancer overall. This varied by age, with a value of 104 U/ml in 40-year-old women and 32 U/ml in 70-year-old women equating to a 3% probability. The main limitations of our study were that we were unable to determine why CA125 tests were performed and that our findings are based solely on UK primary care data, so caution is need in extrapolating them to other healthcare settings. CONCLUSIONS: CA125 is a useful test for ovarian cancer detection in primary care, particularly in women ≥50 years old. Clinicians should also consider non-ovarian cancers in women with high CA125 levels, especially if ovarian cancer has been excluded, in order to prevent diagnostic delay. Our results enable clinicians and patients to determine the estimated probability of ovarian cancer and all cancers at any CA125 level and age, which can be used to guide individual decisions on the need for further investigation or referral.en_GB
dc.description.sponsorshipCancer Research UKen_GB
dc.description.sponsorshipNational Institute for Health Research (NIHR)en_GB
dc.identifier.citationVol. 17 (10), article e1003295en_GB
dc.identifier.doi10.1371/journal.pmed.1003295
dc.identifier.grantnumberC8640/A23385en_GB
dc.identifier.grantnumberFR17 424en_GB
dc.identifier.grantnumberIS-BRC-1215-20007en_GB
dc.identifier.urihttp://hdl.handle.net/10871/123473
dc.language.isoenen_GB
dc.publisherPublic Library of Science (PLoS)en_GB
dc.relation.urlhttps://www.ncbi.nlm.nih.gov/pubmed/33112854en_GB
dc.relation.urlhttps://doi.org/10.17863/CAM.56363en_GB
dc.rights© 2020 Funston et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.en_GB
dc.titleThe diagnostic performance of CA125 for the detection of ovarian and non-ovarian cancer in primary care: A population-based cohort studyen_GB
dc.typeArticleen_GB
dc.date.available2020-11-03T13:45:23Z
exeter.place-of-publicationUnited Statesen_GB
dc.descriptionThis is the final version. Available on open access from the Public Library of Science via the DOI in this recorden_GB
dc.descriptionData Availability: Data cannot be shared publicly as they are analysed under licence. All data used in this study are available from CPRD (www.cprd.com). Permission to access data is through the Independent Scientific Advisory Committee (ISAC, contact via: isac@cprd.com). Derived data used to prepare article figures are available from the University of Cambridge Repository: www.repository.cam.ac.uk (https://doi.org/10.17863/CAM.56363).en_GB
dc.identifier.eissn1549-1676
dc.identifier.journalPLoS Medicineen_GB
dc.rights.urihttps://creativecommons.org/licenses/by/4.0/en_GB
dcterms.dateAccepted2020-09-11
rioxxterms.versionVoRen_GB
rioxxterms.licenseref.startdate2020-10-28
rioxxterms.typeJournal Article/Reviewen_GB
refterms.dateFCD2020-11-03T13:42:47Z
refterms.versionFCDVoR
refterms.dateFOA2020-11-03T13:45:28Z
refterms.panelAen_GB


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© 2020 Funston et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Except where otherwise noted, this item's licence is described as © 2020 Funston et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.