Bladder Cancer Clinical Trial
A Novel Multiplex ELISA Assay for Evaluating Patients With Microscopic Hematuria for Bladder Cancer
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.
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.
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)
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