Urinary Biomarkers for Early Detection of Bladder Cancer: A Prospective Multi-Center Study.
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Abstract
Bladder cancer is an important and common cancer of the urinary tract, prone to high rates of recurrence and the need for invasive diagnostic procedures. Urinary biomarkers are being considered non-invasive diagnostic tools for early detection. To evaluate the diagnostic performance of urinary biomarkers for the early detection of bladder cancer in a prospective multi-center study. A prospective multi-center study conducted at clinical sites in several countries enrolling patients with suspected bladder cancer and control subjects. These solutions included molecular, protein-based, and cytological markers. The diagnostic test accuracy of these solutions was determined utilizing sensitivity, specificity, and predictive values, in comparisons to another standard, cystoscopy and histopathological findings. A total of 1,302 patients were enrolled in multiple centers. Several urinary biomarkers, including nuclear matrix proteins, DNA methylation markers, and microRNAs were noted to have high levels of sensitivity and specificity in early-stage diagnosis. The combined biomarker panels had superior diagnostic accuracy than individual biomarkers, and they significantly accelerated the need for invasive procedures in certain patient groups.