对尿液细胞学检查呈良性的膀胱癌患者，采用尿液样本的形态学和荧光原位杂交联合分析进行膀胱癌检测及随访。

Combined morphologic and fluorescence in situ hybridization analysis of voided urine samples for the detection and follow-up of bladder cancer in patients with benign urine cytology.

作者信息

Daniely Michal, Rona Roni, Kaplan Tal, Olsfanger Shirley, Elboim Lea, Freiberger Avner, Lew Sylvia, Leibovitch Ilan

机构信息

BioView Ltd, Rehovot, Israel.

出版信息

Cancer. 2007 Dec 25;111(6):517-24. doi: 10.1002/cncr.23119.

DOI:10.1002/cncr.23119

PMID:17963263

Abstract

BACKGROUND

Bladder cancer is among the 5 most common malignancies worldwide. Patients with bladder cancer are closely followed with periodic cystoscopies and urine cytology analyses due to the significant risk of tumor recurrence. The UroVysion fluorescence in situ hybridization (FISH) test demonstrated higher sensitivity over urine cytology in detecting bladder cancer by most comparative studies.

METHODS

In the current study, the diagnostic usefulness of a combined cytology and FISH analysis approach was tested using the Duet automatic scanning system in patients with benign urine cytology who were being monitored for recurrent urothelial carcinoma or being assessed for various urologic symptoms.

RESULTS

By combining the benefits of conventional cytology with molecular diagnostics, a more sensitive detection of bladder cancer was attained. All patients who had positive cystoscopy concomitantly with urine sampling were detected by combined analysis. Additional patients that developed transitional cell carcinoma during a follow-up period of 24 months had a previous positive result on combined analysis. Only 2 patients with a negative combined analysis result presented with late disease recurrence (20 months and 22 months, respectively, after the negative test). Therefore, negative combined analysis was found to be predictive of a lack of disease recurrence for at least 12 months. In this timeframe, the overall sensitivity, specificity, negative predictive value (NPV), and positive predictive values of the combined analysis test were 100%, 65%, 100%, and 44%, respectively.

CONCLUSIONS

Given the absolute sensitivity and NPV of the combined analysis test, the management of patients with a negative combined analysis result might be revised and allow for more flexible assessment and management of bladder cancer patients relying more on urine bound tests.

摘要

背景

膀胱癌是全球最常见的5种恶性肿瘤之一。由于肿瘤复发风险高，膀胱癌患者需定期进行膀胱镜检查和尿液细胞学分析以密切随访。大多数比较研究表明，UroVysion荧光原位杂交（FISH）检测在检测膀胱癌方面比尿液细胞学具有更高的灵敏度。

方法

在本研究中，使用Duet自动扫描系统对尿液细胞学检查结果为良性、正在接受复发性尿路上皮癌监测或因各种泌尿系统症状接受评估的患者，测试了细胞学和FISH联合分析方法的诊断效用。

结果

通过将传统细胞学的优势与分子诊断相结合，实现了对膀胱癌更灵敏的检测。联合分析检测出了所有膀胱镜检查阳性且同时进行尿液采样的患者。在24个月的随访期内发生移行细胞癌的其他患者，联合分析此前结果为阳性。只有2例联合分析结果为阴性的患者出现疾病晚期复发（分别在阴性检测后20个月和22个月）。因此，发现联合分析结果为阴性可预测至少12个月内无疾病复发。在此时间范围内，联合分析检测的总体灵敏度、特异性、阴性预测值（NPV）和阳性预测值分别为100%、65%、100%和44%。