Prospective external validation of a bladder cancer detection model.

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.

• Authors: Yair Lotan, Robert S Svatek, Laura-Maria Krabbe, Evanguelos Xylinas, Tobias Klatte, Shahrokh F Shariat
• Journal: The Journal of urology (J Urol) Vol. 192 Issue 5 Pg. 1343-8 (Nov 2014) ISSN: 1527-3792 [Electronic] United States
• PMID: 24859442 (Publication Type: Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't, Validation Study)
• Copyright: Copyright © 2014 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

Chemical References

• Biomarkers, Tumor
• Nuclear Proteins
• nuclear matrix protein 22

Topics

• Aged
• Biomarkers, Tumor (metabolism)
• Carcinoma, Transitional Cell (complications, diagnosis, metabolism)
• Cystoscopy (methods)
• Diagnosis, Differential
• Female
• Follow-Up Studies
• Hematuria (diagnosis, etiology)
• Humans
• Male
• Nuclear Proteins (metabolism)
• Predictive Value of Tests
• Prospective Studies
• Urinalysis
• Urinary Bladder Neoplasms (complications, diagnosis, metabolism)