MP10-20 PROSPECTIVE EVALUATION OF A CLINICAL TOOL FOR SEGREGATION OF HEMATURIA PATIENTS AT RISK FOR HIGH-GRADE UROTHELIAL CARCINOMA

Abstract

You have accessJournal of UrologyBladder Cancer: Epidemiology & Evaluation II1 Apr 2017MP10-20 PROSPECTIVE EVALUATION OF A CLINICAL TOOL FOR SEGREGATION OF HEMATURIA PATIENTS AT RISK FOR HIGH-GRADE UROTHELIAL CARCINOMA Jay D. Raman, Laimonis Kavaliers, Paul O'Sullivan, David Darling, Parry Guilford, and Jimmie Suttie Jay D. RamanJay D. Raman More articles by this author , Laimonis KavaliersLaimonis Kavaliers More articles by this author , Paul O'SullivanPaul O'Sullivan More articles by this author , David DarlingDavid Darling More articles by this author , Parry GuilfordParry Guilford More articles by this author , and Jimmie SuttieJimmie Suttie More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2017.02.348AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES To-date there are no urine-based tests that provide clinical resolution of the severity or grade of urothelial carcinoma (UC) in patients presenting with primary hematuria. Such information permits timely diagnosis and specific management of hematuria patients identified with high grade and/or advanced UC disease. The objective of this study was, therefore, to develop and investigate the performance of Cxbladder Resolve, a new urine-based test offering identification and accurate segregation of patients with high-grade (HG) and/or late-stage disease at the time of initial urological investigation. METHODS Participants in the study (N=863) were recruited from patients presenting with micro-(n=66) or macrohematuria (n=797) across centers in the U.S., New Zealand and Australia. An index incorporating 2 clinical variables and 5 gene expression biomarkers measured in urine was developed to segregate patients into 3 groups: 1. Low risk of UC; 2. Elevated risk of low grade (LG) UC; and 3. High risk of high grade (HG) UC. RESULTS Of the 863 recruited patients, 89 (10.3%) primary cases of UC were observed including 40 LG and 49 HG. Cxbladder Resolve segregated the 863 participants into: low risk of UC (n=479; 55%), elevated risk of LG UC (n=288; 33%) and high risk of HG UC disease (n=96; 11%). (Table) Of the 40 patients with LG bladder tumors, 27 were correctly categorized as Elevated risk of low grade UC, with the remainder; 9 as High risk of HG UC, and 4 as Low risk of UC. Of the 49 patients with HG UC, 47 (96%) were correctly identified as having High risk of HG UC and the remaining 2 patients were classified as elevated risk of LG UC. No patients with HG UC were classified as low risk of UC. Overall a negative predictive value [NPV] of =99% was observed. CONCLUSIONS Cxbladder Resolve accurately identifies over 95% of HG UC patients with a reciprocal high NPV (99%) for low risk patients. The index has a low probability of incorrectly classifying pathologic HG UC patients as low risk. Clinical utility is demonstrated for stratifying hematuria patients into risk groups allowing for prioritization of high risk patients with aggressive disease requiring early investigative procedures. © 2017FiguresReferencesRelatedDetails Volume 197Issue 4SApril 2017Page: e116 Advertisement Copyright & Permissions© 2017MetricsAuthor Information Jay D. Raman More articles by this author Laimonis Kavaliers More articles by this author Paul O'Sullivan More articles by this author David Darling More articles by this author Parry Guilford More articles by this author Jimmie Suttie More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...