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• W1968573729 abstract "No AccessJournal of UrologyInvestigative Urology1 Jan 2014Validation Study of a Noninvasive Urine Test for Diagnosis and Prognosis Assessment of Bladder Cancer: Evidence for Improved Models Lourdes Mengual, María José Ribal, Juan José Lozano, Mercedes Ingelmo-Torres, Moisés Burset, Pedro Luís Fernández, and Antonio Alcaraz Lourdes MengualLourdes Mengual Laboratory and Department of Urology, Hospital Clínic, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Universitat de Barcelona, Barcelona, Spain Equal study contribution. More articles by this author , María José RibalMaría José Ribal Laboratory and Department of Urology, Hospital Clínic, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Universitat de Barcelona, Barcelona, Spain Equal study contribution. More articles by this author , Juan José LozanoJuan José Lozano Plataforma de Bioinformática, Centro de Investigación Biomédica en red de Enfermedades Hepáticas y Digestivas, Hospital Clínic, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Universitat de Barcelona, Barcelona, Spain More articles by this author , Mercedes Ingelmo-TorresMercedes Ingelmo-Torres Laboratory and Department of Urology, Hospital Clínic, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Universitat de Barcelona, Barcelona, Spain More articles by this author , Moisés BursetMoisés Burset Laboratory and Department of Urology, Hospital Clínic, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Universitat de Barcelona, Barcelona, Spain More articles by this author , Pedro Luís FernándezPedro Luís Fernández Pathology Department, Hospital Clínic, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Universitat de Barcelona, Barcelona, Spain More articles by this author , and Antonio AlcarazAntonio Alcaraz Laboratory and Department of Urology, Hospital Clínic, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Universitat de Barcelona, Barcelona, Spain More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2013.06.083AboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract Purpose: We validated the performance of our previously reported test for bladder cancer based on urine gene expression patterns using an independent cohort. We also ascertained whether alternative models could achieve better accuracy. Materials and Methods: Gene expression patterns of the previously reported 48 genes, including the 12 + 2 genes of the signature, were analyzed by TaqMan® arrays in an independent set of 207 urine samples. We pooled all samples analyzed to date to obtain a larger training set of 404 and used it to search for putative improved new models. Results: Our 12 + 2 gene expression signature had overall 80% sensitivity with 86% specificity (AUC 0.914) to discriminate between bladder cancer and control samples. It had 75% sensitivity and 75% specificity (AUC 0.83) to predict tumor aggressiveness in the validation set of urine samples. After grouping all samples 3 new signatures for diagnosis containing 2, 5 and 10 genes, respectively, and 1 containing 6 genes for prognosis were designed. Diagnostic performance of the 2, 5, 10 and 12-gene signatures was maintained or improved in the enlarged sample set (AUC 0.913, 0.941, 0.949 and 0.944, respectively). Performance to predict aggressiveness was also improved in the 14 and 6-gene signatures (AUC 0.855 and 0.906, respectively). Conclusions: This validation study confirms the accuracy of the 12 + 2 gene signature as a noninvasive tool for assessing bladder cancer. We present improved models with fewer genes that must be validated in future studies. References 1 : Surveillance for recurrent bladder cancer using a point-of-care proteomic assay. JAMA2006; 295: 299. Google Scholar 2 : Tumor markers in the diagnosis of primary bladder cancer. A systematic review. J Urol2003; 169: 1975. Link, Google Scholar 3 : Bladder tumor markers beyond cytology: International Consensus Panel on bladder tumor markers. Urology2005; 66: 35. Google Scholar 4 : Biomarkers in bladder cancer. Histopathology2010; 57: 1. 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Google Scholar 16 Hastie TJ and Pregibon D: Generalized linear models. In: Statistical Models in S. Edited by JM Chambers and TJ Hastie. Independence, Kentucky: Wadsworth & Brooks Cole 1992. Google Scholar 17 : pROC: an open-source package for R and S+ to analyze and compare ROC curves. BMC Bioinformatics2011; 12: 77. Google Scholar 18 : A global test for groups of genes: testing association with a clinical outcome. Bioinformatics2004; 20: 93. Google Scholar 19 : Clinical model of lifetime cost of treating bladder cancer and associated complications. Urology2006; 68: 549. Google Scholar 20 : Bladder cancer biomarkers and their role in surveillance and screening. Int J Urol2009; 16: 23. Google Scholar 21 : Bladder cancer: translating molecular genetic insights into clinical practice. Hum Pathol2011; 42: 455. Google Scholar 22 : A multigene urine test for the detection and stratification of bladder cancer in patients presenting with hematuria. J Urol2012; 188: 741. Link, Google Scholar 23 : Bladder cancer-associated gene expression signatures identified by profiling of exfoliated urothelia. Cancer Epidemiol Biomarkers Prev2009; 18: 444. Google Scholar 24 : A candidate molecular biomarker panel for the detection of bladder cancer. Cancer Epidemiol Biomarkers Prev2012; 21: 2149. Google Scholar 25 : Contemporary management of stage T1 transitional cell carcinoma of the bladder. J Urol2002; 167: 1573. Link, Google Scholar 26 : Targeting the insulin-like growth factor-1 receptor in human cancer. Front Pharmacol2013; 4: 30. Google Scholar 27 : Hedgehog pathway activation in human transitional cell carcinoma of the bladder. Br J Cancer2012; 106: 1177. Google Scholar 28 : Mage-A cancer/testis antigens inhibit p53 function by blocking its interaction with chromatin. Cancer Res2010; 70: 10362. Google Scholar 29 : Expression of MAGE-A3, NY-ESO-1. LAGE-1 and PRAME in urothelial carcinoma. Br J Cancer2012; 107: 116. Google Scholar 30 : Bladder cancer or bladder cancers? Genetically distinct malignant conditions of the urothelium. Urol Oncol2010; 28: 409. Google Scholar © 2014 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetailsCited byChang S (2016) Re: Gene Expression Test for the Non-Invasive Diagnosis of Bladder Cancer: A Prospective, Blinded, International and Multicenter Validation StudyJournal of Urology, VOL. 196, NO. 4, (1044-1046), Online publication date: 1-Oct-2016.Klatte T and Shariat S (2013) Novel Urinary Markers for Detection of Bladder Cancer—Are we Failing?Journal of Urology, VOL. 191, NO. 1, (9-10), Online publication date: 1-Jan-2014.Andersson K (2013) This Month in Investigative UrologyJournal of Urology, VOL. 191, NO. 1, (5-6), Online publication date: 1-Jan-2014. Volume 191Issue 1January 2014Page: 261-269Supplementary Materials Advertisement Copyright & Permissions© 2014 by American Urological Association Education and Research, Inc.Keywordsbiological markersurotheliumurinary bladdercarcinomagene expressionAcknowledgmentsHelena Kruyer assisted with English.MetricsAuthor Information Lourdes Mengual Laboratory and Department of Urology, Hospital Clínic, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Universitat de Barcelona, Barcelona, Spain Equal study contribution. More articles by this author María José Ribal Laboratory and Department of Urology, Hospital Clínic, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Universitat de Barcelona, Barcelona, Spain Equal study contribution. More articles by this author Juan José Lozano Plataforma de Bioinformática, Centro de Investigación Biomédica en red de Enfermedades Hepáticas y Digestivas, Hospital Clínic, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Universitat de Barcelona, Barcelona, Spain More articles by this author Mercedes Ingelmo-Torres Laboratory and Department of Urology, Hospital Clínic, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Universitat de Barcelona, Barcelona, Spain More articles by this author Moisés Burset Laboratory and Department of Urology, Hospital Clínic, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Universitat de Barcelona, Barcelona, Spain More articles by this author Pedro Luís Fernández Pathology Department, Hospital Clínic, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Universitat de Barcelona, Barcelona, Spain More articles by this author Antonio Alcaraz Laboratory and Department of Urology, Hospital Clínic, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Universitat de Barcelona, Barcelona, Spain More articles by this author Expand All Advertisement PDF downloadLoading ..." @default.
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