Clinical Trial: Hematuria Evaluation Trial for Subjects With Microscopic or Gross Hematuria to Determine the Absence or Presence of Bladder Cancer

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Phase 3 Study of Hematuria Evaluation

Brief Summary: The purpose of the study is to evaluate subjects with gross or microscopic hematuria undergoing scheduled cystoscopy to determine the absence or presence of bladder cancer.

Detailed Summary:
Sponsor: Predictive Biosciences

Current Primary Outcome: To establish the performance characteristics of the Predictive Biosciences Assay relative to the cystoscopy results for subjects undergoing evaluation for the referral diagnosis of gross or microscopic hematuria [ Time Frame: Initial Visit only ]

Original Primary Outcome: Same as current

Current Secondary Outcome: To establish the performance characteristics of the PB assay relative to urine cytology results for subjects undergoing evaluation for the referral diagnosis of gross or microscopic hematuria. [ Time Frame: Initial Visit ]

Original Secondary Outcome: Same as current

Information By: Predictive Biosciences

Dates:
Date Received: September 10, 2009
Date Started: July 2009
Date Completion:
Last Updated: June 7, 2011
Last Verified: November 2009