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Prospective external validation of a bladder cancer detection model

J Urol. 2014 Nov;192(5):1343-8.

J Urol. 2014 Nov;192(5):1343-8.

Abstract

PURPOSE:

Few studies have combined clinical prognostic factors with urinary biomarkers into risk profiles that can be used to predict the likelihood of bladder cancer. We previously developed and internally validated a bladder cancer detection nomogram that combines clinical features with the NMP22® BladderChek® test. To consider extensive use of the model the nomogram was tested in a prospective cohort of patients who presented with hematuria.

MATERIALS AND METHODS:

Patients referred for hematuria evaluation were prospectively enrolled at 3 centers. Each patient underwent complete urological evaluation, including history, examination, cystoscopy, cytology and NMP22. A logistic regression model to predict urothelial bladder carcinoma was also developed to compare the performance of clinical data with and without adding NMP22 and urinary cytology.

RESULTS:

The study included 381 patients (50.7% women) with a median age of 58 years. Urothelial bladder carcinoma was detected in 23 patients (6%). It was associated with age greater than 65 (11.1% vs 4% of patients, p = 0.012), male gender (10.1% vs 2%, p = 0.003), white ethnicity (9.2% vs 3.1%, p = 0.016), gross hematuria (9.9% vs 2.5%, p = 0.005), positive NMP22 (37% vs 3.7%, p <0.001) and positive cytology (83.3% vs 3.9%, p <0.001). Predictive accuracy of the bladder cancer detection nomogram was 80.2%. The calibration plot indicated that the previously published nomogram was well calibrated in patients with a less than 15% predicted probability of urothelial bladder carcinoma.

CONCLUSIONS:

We prospectively validated a highly accurate tool that combines clinical factors and a urinary biomarker to detect bladder cancer. This tool can help prioritize urological referrals for patients with hematuria.

Copyright © 2014 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

KEYWORDS:

hematuria; nuclear matrix protein 22; prognosis; urinary bladder; urinary bladder neoplasms

Comment from Maria Ribal: Molecular markers are not yet approved for use in bladder cancer management. Huge efforts are being performed to incorporate molecular marker to clinical practice in order to improve our current outcomes on bladder cancer. The authors in this article externally validate a previously reported nomogram including both, clinical and molecular information, which could help to better stratify patients into risk of bladder cancer.

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