A Novel Multiplex ELISA Assay for Surveilling Patients With History of Bladder Cancer
- Conditions
- Bladder Cancer
- Registration Number
- NCT03193515
- Lead Sponsor
- Cedars-Sinai Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria<br><br>Participants must be:<br><br> - Age 18 years or older<br><br> - Have a history of non-muscle invasive bladder cancer or muscle invasive bladder<br> cancer treated by bladder sparing techniques (or not yet treated) and diagnosed<br> within the past 24 months on cystoscopic surveillance<br><br> - Participants may be treated with adjuvant intravesical therapy<br><br> - Willing and able to give written informed consent (see Appendix 1)<br><br> - Be willing to adhere to the surveillance regimen (high risk and intermediate risk<br> seen every 3 months for 2 years; low risk seen every 6-12 months for 2 years)<br><br>Exclusion Criteria:<br><br>Participants must not:<br><br> - Have had radical cystectomy<br><br> - History of previous cancer (excluding bladder, basal and squamous cell skin cancer)<br> within the past 3 years<br><br> - Have a known active urinary tract infection or urinary retention<br><br> - Have active stone disease (renal or bladder) or renal insufficiency (creatinine >2.0<br> mg/dL) - Serum creatinine value can be up to 60 days before consent, otherwise<br> repeat.<br><br> - Have ureteral stents, nephrostomy tubes or bowel interposition<br><br> - Have recent genitourinary instrumentation (within 10 days prior to signing consent)<br><br> - Be unable or unwilling to complete the surveillance regimen
Not provided
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Sensitivity and specificity of multiplex ELISA assay will be confirmed by cystoscopy.
- Secondary Outcome Measures
Name Time Method Sensitivity and specificity of multiplex ELISA assay will be compared to VUC and NMP22 BladderCheck.