A Novel Multiplex ELISA Assay for Evaluating Patients With Gross Hematuria for Bladder Cancer

Inclusion Criteria: * Age 18 years or older * Have documented or reported gross hematuria within 3 month of study enrollment * Willing and able to give written informed consent Exclusion Criteria (patients must not): * Have history of BCa * History of previous cancer (excluding basal and squamous cell skin cancer) within the past 3 years * Have a known active urinary tract infection or urinary retention * Have active stone disease (renal or bladder) or renal insufficiency (creatinine \>2.0 mg/dL) Serum creatinine value can be up to 60 days before consent, otherwise repeat * Have ureteral stents, nephrostomy tubes or bowel interposition * Have recent genitourinary instrumentation (within 10 days prior to signing consent) * Be unable or unwilling to complete the hematuria evaluation (i.e., cystoscopy and upper tract imaging)