A Novel Multiplex ELISA Assay for Evaluating Patients With Microscopic Hematuria for Bladder Cancer
- Conditions
- Bladder Cancer
- Registration Number
- NCT03193541
- Lead Sponsor
- Cedars-Sinai Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - Age 18 years or older<br><br> - Have documented or reported microscopic hematuria within 3 month of study enrollment<br><br> - Willing and able to give written informed consent<br><br>Exclusion Criteria (participants must not):<br><br> - Have history of BCa<br><br> - History of previous cancer (excluding basal and squamous cell skin cancer)<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)<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 hematuria evaluation (i.e., cystoscopy and<br> upper tract imaging)
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 NMP-22 BladderChek.