A Novel Multiplex ELISA Assay for Surveilling Patients with History of Bladder Cancer

Inclusion Criteria

Participants must be:

• Age 18 years or older

• Have a history of non-muscle invasive bladder cancer or muscle invasive bladdercancer treated by bladder sparing techniques (or not yet treated) and diagnosedwithin the past 24 months on cystoscopic surveillance

• Participants may be treated with adjuvant intravesical therapy

• Willing and able to give written informed consent (see Appendix 1)

• Be willing to adhere to the surveillance regimen (high risk and intermediate riskseen every 3 months for 2 years; low risk seen every 6-12 months for 2 years)

Exclusion Criteria:

Participants must not:

• Have had radical cystectomy

• History of previous cancer (excluding bladder, 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 >2.0mg/dL) - Serum creatinine value can be up to 60 days before consent, otherwiserepeat.

• 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 surveillance regimen