A Novel Multiplex ELISA Assay for Evaluating Patients With Microscopic Hematuria for Bladder Cancer
Purpose
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.
Condition
- Bladder Cancer
Eligibility
- Eligible Ages
- Between 18 Years and 90 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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)
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Recruiting Locations
Long Beach 5367929, California 5332921 90822
Los Angeles 5368361, California 5332921 90048
Los Angeles 5368361, California 5332921 90095
Newport Beach 5376890, California 5332921 92663
Rochester 5134086, New York 5128638 14620
Dallas 4684888, Texas 4736286 75390
More Details
- Status
- Recruiting
- Sponsor
- Cedars-Sinai Medical Center
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.