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Development and Preliminary Evaluation of a Multivariate Index Assay for Ovarian Cancer 英文参考文献.docVIP

Development and Preliminary Evaluation of a Multivariate Index Assay for Ovarian Cancer 英文参考文献.doc

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Development and Preliminary Evaluation of a Multivariate Index Assay for Ovarian Cancer 英文参考文献

DevelopmentandPreliminaryEvaluationofa MultivariateIndexAssayforOvarianCancer SurajD.Amonkar.,GregP.Bertenshaw.,Tzong-HaoChen,KatharineJ.Bergstrom,JinghuaZhao, ParthaSeshaiah,PingYip,BrianC.Mansfield* CorrelogicSystems,Inc.,Rockville,Maryland,UnitedStatesofAmerica Abstract Background: Mostwomenwithaclinicalpresentationconsistentwithovariancancerhavebenignconditions.Therefore methodstodistinguishwomenwithovariancancerfromthosewithbenignconditionswouldbebeneficial.Wedescribethe development and preliminary evaluation of a serum-based multivariate assay for ovarian cancer. This hypothesis-driven studyexaminedwhetheraninformativepatterncouldbedetectedinstageIdiseasethatpersiststhroughlaterstages. Methodology/Principal Findings: Sera, collected under uniform protocols from multiple institutions, representing 176 cases and 187 controls from women presenting for surgery were examined using high-throughput, multiplexed immunoassays. All stages and common subtypes of epithelial ovarian cancer, and the most common benign ovarian conditionswererepresented.Apanelof104antigens,44autoimmuneand56infectiousdiseasemarkerswereassayedand informativecombinationsidentified.Usingatrainingsetof91stageIdatasets,representing61individualsamples,andan equivalentnumberofcontrols,an11-analyteprofile,composedofCA-125,CA19-9,EGF-R,C-reactiveprotein,myoglobin, apolipoprotein A1, apolipoprotein CIII, MIP-1a, IL-6, IL-18 and tenascin C was identified and appears informative for all stagesandcommonsubtypesofovariancancer.Usingatestingsetof245samples,approximatelytwicethesizeofthe modelbuildingset,theclassifierhad91.3%sensitivityand88.5%specificity.Whilethesepreliminaryresultsarepromising, furtherrefinementandextensivevalidationoftheclassifierinaclinicaltrialisnecessarytodetermineifthetesthasclinical value. Conclusions/Significance: We describe a blood-based assay using 11 analytes that can distinguish women with ovarian cancer from those with benign conditions. Preliminary evaluation of the classif

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