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.
Study Type
OBSERVATIONAL
Enrollment
900
VA Long Beach Healthcare System
Long Beach, California, United States
RECRUITINGCedars-Sinai Medical Center
Los Angeles, California, United States
RECRUITINGUCLA Medical Center
Los Angeles, California, United States
Sensitivity and specificity of multiplex ELISA assay will be confirmed by cystoscopy.
Time frame: 1 year
Sensitivity and specificity of multiplex ELISA assay will be compared to VUC and NMP-22 BladderChek.
Time frame: 1 year
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Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States
RECRUITINGUniversity of Rochester Medical Center
Rochester, New York, United States
RECRUITINGUT Southwestern Medical Center at Dallas
Dallas, Texas, United States
RECRUITINGNara Prefecture Seiwa Medical Center
Nara, Nara, Japan
RECRUITINGNara Medical University
Nara, Japan
RECRUITING