A Novel Multiplex ELISA Assay for Evaluating Patients With Microscopic Hematuria for Bladder Cancer


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Primary Outcome Measures:

  • Sensitivity and specificity of multiplex ELISA assay will be confirmed by cystoscopy. [ Time Frame: 1 year ]
Secondary Outcome Measures:

  • Sensitivity and specificity of multiplex ELISA assay will be compared to VUC and NMP-22 BladderChek. [ Time Frame: 1 year ]

Urine collection (minimal 50 mL) and cystoscopy (+ biopsy w/in 4 weeks, if abnormal noted)

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.