Overview
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 signature in voided urine samples of patients with microscopic hematuria.
Eligibility
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)