A Multigene Urine Test for the Detection and Stratification of Bladder Cancer in Patients Presenting with Hematuria
2012; Lippincott Williams & Wilkins; Volume: 188; Issue: 3 Linguagem: Inglês
10.1016/j.juro.2012.05.003
ISSN1527-3792
AutoresP.J. O’Sullivan, Katrina Sharples, Mark E. Dalphin, Peter J. Davidson, Peter Gilling, Lisa Cambridge, Justin Harvey, Tumi Toro, Nardia Giles, Carthika Luxmanan, Cris Felipe Alves, Han‐Seung Yoon, Victoria Hinder, Jonathan Masters, Andrew Kennedy‐Smith, Tony Beaven, Parry Guilford,
Tópico(s)Urinary Bladder and Prostate Research
ResumoNo AccessJournal of UrologyAdult Urology1 Sep 2012A Multigene Urine Test for the Detection and Stratification of Bladder Cancer in Patients Presenting with Hematuriais corrected byErratum Paul O'Sullivan, Katrina Sharples, Mark Dalphin, Peter Davidson, Peter Gilling, Lisa Cambridge, Justin Harvey, Tumi Toro, Nardia Giles, Carthika Luxmanan, Cris Felipe Alves, Han-Seung Yoon, Victoria Hinder, Jonathan Masters, Andrew Kennedy-Smith, Tony Beaven, and Parry J. Guilford Paul O'SullivanPaul O'Sullivan Pacific Edge Ltd, Dunedin, New Zealand , Katrina SharplesKatrina Sharples Cancer Trials New Zealand, University of Auckland, Auckland, New Zealand Department of Preventive and Social Medicine, University of Otago, Dunedin, New Zealand , Mark DalphinMark Dalphin Pacific Edge Ltd, Dunedin, New Zealand , Peter DavidsonPeter Davidson Canterbury Urology Research Trust, Christchurch, New Zealand , Peter GillingPeter Gilling Tauranga Urology Research Ltd, Tauranga, New Zealand , Lisa CambridgeLisa Cambridge Pacific Edge Ltd, Dunedin, New Zealand , Justin HarveyJustin Harvey Pacific Edge Ltd, Dunedin, New Zealand , Tumi ToroTumi Toro Pacific Edge Ltd, Dunedin, New Zealand , Nardia GilesNardia Giles Pacific Edge Ltd, Dunedin, New Zealand , Carthika LuxmananCarthika Luxmanan Pacific Edge Ltd, Dunedin, New Zealand , Cris Felipe AlvesCris Felipe Alves Pacific Edge Ltd, Dunedin, New Zealand , Han-Seung YoonHan-Seung Yoon Department of Pathology, University of Otago, Dunedin, New Zealand , Victoria HinderVictoria Hinder Cancer Trials New Zealand, University of Auckland, Auckland, New Zealand , Jonathan MastersJonathan Masters Auckland City Hospital and Middlemore Hospital, Auckland, New Zealand , Andrew Kennedy-SmithAndrew Kennedy-Smith Wakefield Hospital, Wellington, New Zealand , Tony BeavenTony Beaven North Shore Hospital, Takapuna, Auckland, New Zealand , and Parry J. GuilfordParry J. Guilford Pacific Edge Ltd, Dunedin, New Zealand Cancer Genetics Laboratory, University of Otago, Dunedin, New Zealand View All Author Informationhttps://doi.org/10.1016/j.juro.2012.05.003AboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract Purpose: We investigated whether the RNA assay uRNA® and its derivative Cxbladder® have greater sensitivity for the detection of bladder cancer than cytology, NMP22™ BladderChek™ and NMP22™ ELISA, and whether they are useful in risk stratification. Materials and Methods: A total of 485 patients presenting with gross hematuria but without a history of urothelial cancer were recruited prospectively from 11 urology clinics in Australasia. Voided urine samples were obtained before cystoscopy. The sensitivity and specificity of the RNA tests were compared to cytology and the NMP22 assays using cystoscopy as the reference. The ability of Cxbladder to distinguish between low grade, stage Ta urothelial carcinoma and more advanced urothelial carcinoma was also determined. Results: uRNA detected 41 of 66 urothelial carcinoma cases (62.1% sensitivity, 95% CI 49.3–73.8) compared with NMP22 ELISA (50.0%, 95% CI 37.4–62.6), BladderChek (37.9%, 95% CI 26.2–50.7) and cytology (56.1%, 95% CI 43.8–68.3). Cxbladder, which was developed on the study data, detected 82%, including 97% of the high grade tumors and 100% of tumors stage 1 or greater. The cutoffs for uRNA and Cxbladder were prespecified to give a specificity of 85%. The specificity of cytology was 94.5% (95% CI 91.9–96.5), NMP22 ELISA 88.0%, (95% CI 84.6–91.0) and BladderChek 96.4% (95% CI 94.2–98.0). Cxbladder distinguished between low grade Ta tumors and other detected urothelial carcinoma with a sensitivity of 91% and a specificity of 90%. 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Google Scholar © 2012 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetailsCited byLotan Y, Raman J, Konety B, Daneshmand S, Schroeck F, Shariat S, Black P, de Lange M, Asroff S, Goldfischer E, Efros M, Chong K, Huang E, Chua H, Wu Q, Yeow S, Lau W, Yong J and Eng M (2022) Urinary Analysis of FGFR3 and TERT Gene Mutations Enhances Performance of Cxbladder Tests and Improves Patient Risk StratificationJournal of Urology, VOL. 209, NO. 4, (762-772), Online publication date: 1-Apr-2023.Raman J, Kavalieris L, Konety B, Porten S, Daneshmand S, Lotan Y and Loo R (2021) The Diagnostic Performance of Cxbladder Resolve, Alone and in Combination with Other Cxbladder Tests, in the Identification and Priority Evaluation of Patients at Risk for Urothelial CarcinomaJournal of Urology, VOL. 206, NO. 6, (1380-1389), Online publication date: 1-Dec-2021.Wallace E, Higuchi R, Satya M, McCann L, Sin M, Bridge J, Wei H, Zhang J, Wong E, Hiar A, Mach K, Scherr D, Egerdie R, Ohta S, Sexton W, Meng M, Weizer A, Woods M, Jansz G, Zadra J, Lotan Y, Goldfarb B and Liao J (2017) Development of a 90-Minute Integrated Noninvasive Urinary Assay for Bladder Cancer DetectionJournal of Urology, VOL. 199, NO. 3, (655-662), Online publication date: 1-Mar-2018.Kavalieris L, O'Sullivan P, Frampton C, Guilford P, Darling D, Jacobson E, Suttie J, Raman J, Shariat S and Lotan Y (2016) Performance Characteristics of a Multigene Urine Biomarker Test for Monitoring for Recurrent Urothelial Carcinoma in a Multicenter StudyJournal of Urology, VOL. 197, NO. 6, (1419-1426), Online publication date: 1-Jun-2017.Chang 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.Chang S, Boorjian S, Chou R, Clark P, Daneshmand S, Konety B, Pruthi R, Quale D, Ritch C, Seigne J, Skinner E, Smith N and McKiernan J (2016) Diagnosis and Treatment of Non-Muscle Invasive Bladder Cancer: AUA/SUO GuidelineJournal of Urology, VOL. 196, NO. 4, (1021-1029), Online publication date: 1-Oct-2016.Whitson J, Porten S, Hussein A and Meng M (2016) The Efficient and Effective Use of Exfoliative Urinary MarkersUrology Practice, VOL. 3, NO. 3, (195-202), Online publication date: 1-May-2016.Mengual L, Ribal M, Lozano J, Ingelmo-Torres M, Burset M, Fernández P and Alcaraz A (2013) Validation Study of a Noninvasive Urine Test for Diagnosis and Prognosis Assessment of Bladder Cancer: Evidence for Improved ModelsJournal of Urology, VOL. 191, NO. 1, (261-269), Online publication date: 1-Jan-2014.Steers W (2012) This Month in Adult UrologyJournal of Urology, VOL. 188, NO. 3, (687-688), Online publication date: 1-Sep-2012.Related articlesJournal of Urology14 Oct 2013Erratum Volume 188Issue 3September 2012Page: 741-747 Advertisement Copyright & Permissions© 2012 by American Urological Association Education and Research, Inc.Keywordsmolecularpathologyurinary bladder neoplasmsAcknowledgmentsClinical centers included Tauranga Urology Research Ltd: Peter Gilling, Rana Reuther, Jo Pickford; Canterbury Urology Research Trust, Christchurch: Peter Davidson, Liz Mitchell, Lena Gurney, Pam Ayres; North Shore Hospital, Auckland: Tony Beaven, Sue Osbourne; Roundhay Research Centre, Nelson: Patrick Meffan, Janet Evans, Wendy Meffan; Royal Melbourne Hospital: Anthony Costello, Kathryn Chatterton, Pat Bujega; Monash Medical Centre: Mark Frydenburg, Christine Poole; Cardinal Points, Whangerei: Tony Nixon, Sharon Scott; Middlemore Hospital: Jonathan Masters, Yvonne Dunne, Rhonda Litchfield; Auckland City Hospital: Jonathan Masters, Fleur O'Keefe; Devcich Urology Services, Hamilton: Glen Devcich, Lisa Smit; Wakefield Urology Services, Wellington: Andrew Kennedy-Smith, Catherine Acton.MetricsAuthor Information Paul O'Sullivan Pacific Edge Ltd, Dunedin, New Zealand Financial interest and/or other relationship with Pacific Edge Ltd. More articles by this author Katrina Sharples Cancer Trials New Zealand, University of Auckland, Auckland, New Zealand Department of Preventive and Social Medicine, University of Otago, Dunedin, New Zealand More articles by this author Mark Dalphin Pacific Edge Ltd, Dunedin, New Zealand Financial interest and/or other relationship with Pacific Edge Ltd. More articles by this author Peter Davidson Canterbury Urology Research Trust, Christchurch, New Zealand Financial interest and/or other relationship with Pacific Edge Ltd. More articles by this author Peter Gilling Tauranga Urology Research Ltd, Tauranga, New Zealand Financial interest and/or other relationship with Pacific Edge Ltd. More articles by this author Lisa Cambridge Pacific Edge Ltd, Dunedin, New Zealand Financial interest and/or other relationship with Pacific Edge Ltd. More articles by this author Justin Harvey Pacific Edge Ltd, Dunedin, New Zealand Financial interest and/or other relationship with Pacific Edge Ltd. More articles by this author Tumi Toro Pacific Edge Ltd, Dunedin, New Zealand Financial interest and/or other relationship with Pacific Edge Ltd. More articles by this author Nardia Giles Pacific Edge Ltd, Dunedin, New Zealand Financial interest and/or other relationship with Pacific Edge Ltd. More articles by this author Carthika Luxmanan Pacific Edge Ltd, Dunedin, New Zealand Financial interest and/or other relationship with Pacific Edge Ltd. More articles by this author Cris Felipe Alves Pacific Edge Ltd, Dunedin, New Zealand More articles by this author Han-Seung Yoon Department of Pathology, University of Otago, Dunedin, New Zealand More articles by this author Victoria Hinder Cancer Trials New Zealand, University of Auckland, Auckland, New Zealand More articles by this author Jonathan Masters Auckland City Hospital and Middlemore Hospital, Auckland, New Zealand Financial interest and/or other relationship with Pacific Edge Ltd. More articles by this author Andrew Kennedy-Smith Wakefield Hospital, Wellington, New Zealand Financial interest and/or other relationship with Pacific Edge Ltd. More articles by this author Tony Beaven North Shore Hospital, Takapuna, Auckland, New Zealand Financial interest and/or other relationship with Pacific Edge Ltd. More articles by this author Parry J. Guilford Pacific Edge Ltd, Dunedin, New Zealand Cancer Genetics Laboratory, University of Otago, Dunedin, New Zealand Financial interest and/or other relationship with Pacific Edge Ltd. More articles by this author Expand All Advertisement PDF downloadLoading ...
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