title: Performance of urine test in patients monitored for recurrence of bladder cancer: a multicenter study in the United States.
abstract: OBJECTIVE
  We assessed the performance of the ImmunoCyt immunocytochemical test for detecting bladder cancer recurrence in patients with prior superficial bladder cancers compared with cystoscopic and histological findings.
  
  
  METHODS
  A total of 341 patients with a history of bladder cancer undergoing monitoring were evaluated at 4 sites. The results of cytology and/or ImmunoCyt were analyzed for sensitivity and specificity compared with biopsy confirmed cancer.
  
  
  RESULTS
  The overall sensitivity of cytology alone, ImmunoCyt alone and the 2 methods combined was 23%, 81% and 81%, respectively. The specificity of cytology alone, ImmunoCyt alone and of the 2 methods combined was 93%, 75% and 73%, respectively. The immunocytochemical test was more sensitive than cytology for detecting grades 1 and 2, and stages Ta, T1, and T2 urothelial carcinoma, and it was equally sensitive for detecting grade 3 cancers and carcinoma in situ (CIS). The sensitivity of the combined tests for grades 1 to 3/CIS was 79%, 90% and 82%, while for stages Ta, T1, T2+ and CIS it was 83%, 75%, 100% and 100%, respectively. The overall positive and negative predictive values of the combined tests were 37% and 95%, respectively. Importantly the immunocytochemical test could detect 71% of small (less than 1 cm) tumors.
  
  
  CONCLUSIONS
  ImmunoCyt is a sensitive test for detecting bladder cancer. Because of its high sensitivity for detecting small tumors, even those of low histological grade, and its high negative predictive value, this test may have a role in decreasing the frequency of cystoscopic examinations for monitoring patients with low risk bladder cancer.
authors.affiliation: Department of Urology, University of Rochester Medical Center, Rochester, New York 14642, USA. edward_messing@urmc.rochester.edu
authors.forename: Edward M
authors.initials: EM
authors.lastname: Messing
authors.forename: Lisa
authors.initials: L
authors.lastname: Teot
authors.forename: Howard
authors.initials: H
authors.lastname: Korman
authors.forename: Eanne
authors.initials: E
authors.lastname: Underhill
authors.forename: Edward
authors.initials: E
authors.lastname: Barker
authors.forename: Brian
authors.initials: B
authors.lastname: Stork
authors.forename: Junqi
authors.initials: J
authors.lastname: Qian
authors.forename: David G
authors.initials: DG
authors.lastname: Bostwick
mesh_terms: D000911:Antibodies, Monoclonal; D014408:Biomarkers, Tumor / Q000652:urine*; D002295:Carcinoma, Transitional Cell / Q000175:diagnosis*; D003558:Cystoscopy; D003581:Cytodiagnosis; D006801:Humans; D008856:Microscopy, Fluorescence; D008991:Monitoring, Physiologic; D009077:Mucins / Q000652:urine; D009364:Neoplasm Recurrence, Local / Q000175:diagnosis* / Q000473:pathology; D011237:Predictive Value of Tests; D012680:Sensitivity and Specificity; D014481:United States; D001749:Urinary Bladder Neoplasms / Q000175:diagnosis* / Q000473:pathology; D014556:Urine / Q000166:cytology
chemical_list: D000911:Antibodies, Monoclonal; D014408:Biomarkers, Tumor; D009077:Mucins