Brief Title: A Novel Multiplex ELISA Assay for Surveilling Patients With History of Bladder Cancer

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Sensitivity and specificity of multiplex ELISA assay will be confirmed by cystoscopy.

Primary Outcome 1 - Timeframe: 2 years

CONDITION

• Bladder Cancer

ELIGIBILITY

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Hideki Furuya, PhD, Charles Rosser

Role: Principal Investigator, Study Director

Affiliation: Cedars-Sinai Medical Center, Nonagen Bioscience Corporation

Overall Contact

Name: Charles Rosser, MD

Phone: 310-423-5609

Email: [email protected]

LOCATION