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Diagnostic and prognostic performance of Secreted Protein Acidic and Rich in Cysteine (SPARC) assay for detecting primary and recurrent urinary bladder cancer.

PURPOSE: To evaluate the diagnostic and prognostic performance of Secreted Protein Acidic and Rich in Cysteine (SPARC) in detecting urinary bladder cancer (UBC).

METHODS: Among the Integrated Study on Bladder Cancer (ISBLaC) study participants (n = 571; mean age:69.4±12.2 years), two cross-sectional studies assessed SPARC diagnostic performance in primary (n = 264, including 179 primary UBC patients and 85 urological controls) and recurrent (n = 307, including 56 recurrent UBC patients and 251 non-recurrent controls) UBC. SPARC prognostic performance was evaluated in a nested cohort (n = 250) prospectively monitored for disease relapse for 80 months. Baseline urine samples were analyzed blindly using a commercially available SPARC ELISA assay, characterized for its analytical performance according to clinical test regulatory requirements (R&D Manufactures Inc.).

RESULTS: While higher mean SPARC levels were detected in primary (p = 0.008) and recurrent (p<0.0001) UBC, the assay had limited diagnostic performance (AUC:0.593; 95% CI:0.524-0.663). SPARC positive patients undergoing disease monitoring were more likely to develop tumor relapse (age and gender Adjusted Hazard Ratio, Adj. HR:1.52; 95% CI:1.04-2.22) and progression (Adj. HR:1.83; 95% CI:1.02-3.27). However, prognostic performance was affected by hematuria.

CONCLUSIONS AND CLINICAL RELEVANCE: SPARC diagnostic performance appears insufficient for clinical implementation in primary and/or recurrent UBC. In patients undergoing disease monitoring, SPARC is a promising prognostic marker for tumor relapse and/or progression, but is affected by hematuria. This article is protected by copyright. All rights reserved.

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