PI-LBA07 THE DEVELOPMENT AND CLINICAL VALIDATION OF A HIGH SENSITIVITY URINE BIOMARKER TEST FOR THE DETERMINATION OF RECURRENCE IN UROTHELIAL CARCINOMA PATIENTS

Abstract

You have accessJournal of UrologyPlenary I - Tuesday1 Apr 2016PI-LBA07 THE DEVELOPMENT AND CLINICAL VALIDATION OF A HIGH SENSITIVITY URINE BIOMARKER TEST FOR THE DETERMINATION OF RECURRENCE IN UROTHELIAL CARCINOMA PATIENTS Yair Lotan, Jay Raman, Shahrokh Shariat, Laimonis Kavalieris, Chris Frampton, Henry Crist, Elsie Jacobson, Jimmie Suttie, David Darling, Scott Asroff, Doug Scherr, George Adams, Evan Goldfischer, Jeffrey Thill, Joseph Williams, Joshua Stein, and Paul O'Sullivan Yair LotanYair Lotan More articles by this author , Jay RamanJay Raman More articles by this author , Shahrokh ShariatShahrokh Shariat More articles by this author , Laimonis KavalierisLaimonis Kavalieris More articles by this author , Chris FramptonChris Frampton More articles by this author , Henry CristHenry Crist More articles by this author , Elsie JacobsonElsie Jacobson More articles by this author , Jimmie SuttieJimmie Suttie More articles by this author , David DarlingDavid Darling More articles by this author , Scott AsroffScott Asroff More articles by this author , Doug ScherrDoug Scherr More articles by this author , George AdamsGeorge Adams More articles by this author , Evan GoldfischerEvan Goldfischer More articles by this author , Jeffrey ThillJeffrey Thill More articles by this author , Joseph WilliamsJoseph Williams More articles by this author , Joshua SteinJoshua Stein More articles by this author , and Paul O'SullivanPaul O'Sullivan More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2016.03.130AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES To develop a high sensitivity, urine based, gene expression test for the determination of recurrence of Urothelial Carcinoma (UC) and to assess the performance of this test for the segregation of patients with a low probability of recurrence from those requiring further investigation. METHODS 1093 samples were collected from 803 patients prospectively recruited at 11 community and tertiary centres the United States. Voided urine samples were collected pre-cystoscopy for urine dipstick, NMP22 Bladderchek, NMP22 ELISA, urine cytology and Cxbladder. Local cytology and FISH were also collected where available. Patients were partitioned into either a training or validation set based on demographic and risk factors. The training set (n=354 patients) was used to develop a novel algorithm (Cxbladder Monitor) encompassing gene expression data and previous tumor occurrence information. Cxbladder Monitor was validated using an independent validation set (n=449 patients). Final model parameters were derived on all data and bootstrap methods used to estimate 95% CIs and performance characteristics. RESULTS Incidence of confirmed UC within the recruited population was 11%. Confirmed tumor stage was as follows : 64% Ta, 14% T1, 22% Tis. Grade was confirmed as 50% low grade and PUMLMP and 50% high grade disease. Final model Cxbladder Monitor exhibited a sensitivity of 93% (95% CI 82, 97), outperforming all direct comparator tests and locally obtained FISH results, across all stages and grades of tumor; see table 1. Cxbladder Monitor demonstrated an NPV of 97% (95% CI: 93, 98). CONCLUSIONS Cxbladder Monitor has been developed in response to the limitations of current urine based tests, and the unmet clinical need for a high sensitivity, high NPV test to enhance the clinical investigation of recurrent UC. Cxbladder Monitor demonstrated potential to rule out those patients with a low risk of having recurrent disease and therefore to reduce cystoscopy burden on patients undergoing routine investigation. Use of Cxbladder Monitor could reduce the number of invasive procedures required for the evaluation of recurrent UC. © 2016FiguresReferencesRelatedDetails Volume 195Issue 4SApril 2016Page: e1071 Advertisement Copyright & Permissions© 2016MetricsAuthor Information Yair Lotan More articles by this author Jay Raman More articles by this author Shahrokh Shariat More articles by this author Laimonis Kavalieris More articles by this author Chris Frampton More articles by this author Henry Crist More articles by this author Elsie Jacobson More articles by this author Jimmie Suttie More articles by this author David Darling More articles by this author Scott Asroff More articles by this author Doug Scherr More articles by this author George Adams More articles by this author Evan Goldfischer More articles by this author Jeffrey Thill More articles by this author Joseph Williams More articles by this author Joshua Stein More articles by this author Paul O'Sullivan More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...