Patients with a negative cystoscopy and negative Nmp22® Bladderchek® test are at low risk of missed transitional cell carcinoma of the bladder: a prospective evaluation

OBJECTIVES: Urine based tumor markers have uncertain utility in diagnosis or surveillance of patients with bladder cancer while cytology is commonly used. We evaluated whether cytology provides additional diagnostic information in patients with a negative NMP22® BladderChek® test (BladderChek) and negative cystoscopy. MATERIALS AND METHODS: We performed subset analyses of 2 large prospective multi-center databases evaluating BladderChek for UCB detection and surveillance. These cohorts were analyzed for presence of cancer and result of urine cytology in setting of a negative cystoscopy and negative BladderChek. Subsequently, we prospectively performed cystoscopy, cytology and BladderChek on 434 patients at our institution being evaluated for UCB. RESULTS: In the detection database (n = 1331), 1065 patients had a negative cystoscopy and BladderChek. There were 3 cancers (stages Ta, Tis and T1) and cytology was atypical in one and reactive in two. In the surveillance cohort (n = 668) patients, 437 patients had negative cystoscopy and BladderChek. Cancer was found in 2 patients (stages Tis and Ta). The patient with Tis has dysplastic cytology and Ta tumor had reactive cytology. In our cohort of 434 patients, 288 pts had negative cystoscopy and BladderChek. One cancer was missed, a Ta ureteral urothelial carcinoma with a reactive cytology. CONCLUSIONS: In patients with negative cystoscopy and BladderChek, very few cancers are missed and cytology was not effective in detection. Use of a point-of-care test in conjunction with cystoscopy in lieu of cytology could decrease cost, provide immediate results, improve negative predictive value and reduce the uncertainty that results from inconclusive cytologic results.

Urine concentration of nuclear matrix protein 22 for diagnosis of transitional cell carcinoma of bladder

The aim of this study was to determine the diagnostic value of urine nuclear matrix protein 22 [NMP22] level in detection of transitional cell carcinoma [TCC] of the bladder. A total of 76 patients with newly-diagnosed or recurrent TCC and 75 controls without urinary tract disorders participated in this study. A urine sample was obtained for measurement of the NMP22 level using the enzyme-linked immunoabsorbent assay. The resulted values were evaluated in comparison with the results of pathologic examination. A total of 76 patients with TCC of the bladder and 75 volunteers without TCC were enrolled in the study. The mean level of urine NMP22 had an increasing trend associated with tumor grade [P = .01] and tumor stage [P < .001]. In participant without TCC, the mean urinary NMP22 level was 5.48 +/- 6.34 U/mL, while this value was 25.01 +/- 35.33 U/mL in patients with TCC of the bladder [P < .001]. The sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of urine NMP22 for detection of TCC were 75.5%, 86.7%, 85.1%, 77.4%, and 80.8%, respectively. The sensitivity of NMP22 in detecting stage Ta tumors appeared to be low [31.3%], but for grade 1 tumors, the sensitivity was 66.7%. Measurement of urine NMP22 is a noninvasive, highly sensitive, and specific method for detecting TCC of the bladder and estimating its grade and stage. Further studies can be helpful to determine whether it can be used in clinical practice