A Novel Multiplex ELISA Assay for Evaluating Patients With Microscopic Hematuria for Bladder Cancer
Cedars-Sinai Medical Center
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.
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 sig…
Eligibility
- Age range
- 18–90 years
- Sex
- All
- Healthy volunteers
- Not specified
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…
Locations (8)
- VA Long Beach Healthcare SystemLong Beach, California
- Cedars-Sinai Medical CenterLos Angeles, California
- UCLA Medical CenterLos Angeles, California
- Hoag Memorial Hospital PresbyterianNewport Beach, California
- University of Rochester Medical CenterRochester, New York
- UT Southwestern Medical Center at DallasDallas, Texas