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

Phase 3 Study of Hematuria Evaluation

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.

Inclusion Criteria:

• For those subjects for whom there is no family history of bladder cancer or less than a 20 pack year history of cigarette smoking, subject must be 50 or older.
• Subject's age can be lowered to 45 or older if there is a family history of bladder cancer and/or a 20 or greater pack history of cigarette smoking.
• Subject must have an intact bladder
• Subject must be scheduled to have a cystoscopy to screen for transitional call bladder cancer due to the finding of hematuria.
• Subject must be able to provide a minimum of 25 mL of urine for study purposes.
• Urine samples must be available prior to cystoscopy, bladder biopsy, and TUR.
• Subjects must be willing to sign an Institutional Review Board approved written informed consent prior to any study related procedures being performed.

Exclusion Criteria:

• Subject had a history or current diagnosis of any basal or squamous cell cancer.
• Subject had a known diagnosis of any autoimmune disease.
• Subject had known diagnosis of HIV, HCV or HBV
• Subject had disclosed voluntarily history of or current infection with TB or other systemic disease.
• Subject is currently pregnant or lactating.
• Subject had surgery within 30 days prior to enrollment
• Subject has known allergy to benzalkonium chloride.
• Subject participated in an investigational drug or device trial within 30 days prior to enrollment.