Prospective external validation of a bladder cancer detection model

J Urol. 2014 Nov;192(5):1343-8. doi: 10.1016/j.juro.2014.05.087. Epub 2014 May 21.

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.

Keywords: hematuria; nuclear matrix protein 22; prognosis; urinary bladder; urinary bladder neoplasms.

Publication types

  • Multicenter Study
  • Research Support, Non-U.S. Gov't
  • Validation Study

MeSH terms

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

Substances

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