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
To improve upon the non-invasive detection of BCa by further validating a multiplex ELISA assay directed at a BCa-associated diagnostic signature in voided urine samples of patients with microscopic hematuria.
- Detailed Description
Hematuria is the most common presentation of BCa with 8% of patients with microscopic hematuria harboring BCa. VUC is the most widely used urine-based assay for detecting BCa; however, it fails to detect approximately 50% of low-grade or early stage BCa when it is most curable. Because of this severe limitation, patients with hematuria will undergo an invasive examination of the urinary bladder, where a miniature camera is inserted into the bladder.
We propose to improve the non-invasive detection of BCa by further validating a multiplex ELISA assay directed at a BCa-associated diagnostic signature in voided urine samples of patients with microscopic hematuria.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 900
- Age 18 years or older
- Have documented or reported microscopic hematuria within 3 month of study enrollment
- Willing and able to give written informed consent
Exclusion Criteria (participants must not):
- Have history of BCa
- History of previous cancer (excluding basal and squamous cell skin cancer)
- 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)
- 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 hematuria evaluation (i.e., cystoscopy and 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. 1 year
- Secondary Outcome Measures
Name Time Method Sensitivity and specificity of multiplex ELISA assay will be compared to VUC and NMP-22 BladderChek. 1 year
Trial Locations
- Locations (7)
University of Rochester Medical Center
🇺🇸Rochester, New York, United States
Nara Prefecture Seiwa Medical Center
🇯🇵Nara, Japan
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
UT Southwestern Medical Center at Dallas
🇺🇸Dallas, Texas, United States
UCLA Medical Center
🇺🇸Los Angeles, California, United States
VA Long Beach Healthcare System
🇺🇸Long Beach, California, United States
Nara Medical University
🇯🇵Nara, Japan