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 bladder cancer treated by bladder sparing techniques (or not yet treated) and diagnosed within 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 risk seen 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 >2.0 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 surveillance regimen