Surveillance for recurrent bladder cancer using a point-of-care proteomic assay
Surveillance for recurrent bladder cancer using a point-of-care proteomic assay
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DOI：
10.1001/jama.295.3.299
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发表时间：
2006-01-18
影响因子：
120.7
通讯作者：
Shen, Y
中科院分区：
文献类型：
--
作者：
Grossman, HB;Soloway, M;Shen, Y
背景至少50%有膀胱癌病史的患者有复发，因此严格的监测是必要的。膀胱镜检查是标准的，但不能检测到一些膀胱癌，所以尿液检查经常是评估的一部分。目的研究在监测有膀胱癌病史的患者期间，测量排尿中核基质蛋白NMP 22的即时蛋白质组学检测是否可以提高复发的检测。设计，设置和患者从2001年9月至2002年2月，在这项横断面研究中，美国9个州的23个学术、私人诊所和医院机构前瞻性地招募了668名有膀胱癌病史的连续患者。膀胱镜检查前患者提供尿液标本进行NMP 22蛋白和细胞学分析。主要结果测量膀胱镜检查活检的基础上，膀胱癌复发的诊断，被接受为参考标准。将NMP 22检测的性能与作为检测辅助手段的排尿细胞学进行比较。NMP 22肿瘤标志物的检测以盲法进行。结果103例患者被诊断为膀胱癌。仅膀胱镜检查就可识别91.3%的癌症（94/103; 95%置信区间[CI]，84.1%-95.9%）。膀胱镜检查与NMP 22检测的组合检测到99.0%的恶性肿瘤（102/103; 95% CI，94.7%-100%; P=.005）。NMP 22检测检测了9种在初始膀胱镜检查期间不可见的癌症中的8种，包括7种高级别癌症。单纯NMP 22检测的敏感性和特异性分别为49.5%和49.5%，（51/103; 95% CI，39.5%-59.5%）和87.3%（493/565; 95%CI，84.2%-89.9%），在初次膀胱镜检查时漏诊的恶性肿瘤中，尿细胞学检查仅检出3例，且未显著增加膀胱镜检查的敏感性（94.2%;结论尿NMP 22蛋白的无创床旁检测可提高膀胱癌复发的检出率，且检测结果可在患者就诊时获得。
Context At least 50% of patients with a history of bladder cancer have recurrences, so rigorous surveillance is necessary. Cystoscopy is standard but can fail to detect some bladder cancers, so a urine test is frequently part of the evaluation.Objective To investigate whether a point-of-care proteomic test that measures the nuclear matrix protein NMP22 in voided urine could improve detection of recurrence during monitoring of patients with a history of bladder cancer.Design, Setting, and Patients From September 2001 to February 2002, 23 academic, private practice, and hospital facilities in 9 US states prospectively enrolled 668 consecutive patients with a history of bladder cancer in this cross-sectional study. Patients provided a voided urine sample for analysis of NMP22 protein and cytology prior to cystoscopy.Main Outcome Measures Diagnosis of bladder cancer recurrence, based on cystoscopy with biopsy, was accepted as the reference standard. The performance of the NMP22 test was compared with voided urine cytology as an aid to detection. Testing for the NMP22 tumor marker was conducted in a blinded manner.Results Bladder cancer was diagnosed in 103 patients. Cystoscopy alone identified 91.3% of the cancers (94/103; 95% confidence interval [CI], 84.1%-95.9%). The combination of cystoscopy with the NMP22 assay detected 99.0% of the malignancies (102/103; 95% CI, 94.7%-100%; P=.005). The NMP22 assay detected 8 of 9 cancers that were not visualized during initial cystoscopy, including 7 that were high-grade. The sensitivity and specificity of the NMP22 test alone were 49.5% (51/103; 95% CI, 39.5%-59.5%) and 87.3% (493/565; 95% CI, 84.2%-89.9%), respectively, Voided cytology detected only 3 of the malignancies missed during initial cystoscopy and did not significantly increase the sensitivity of cystoscopy (94.2%; 95% CI, 87.7%-97.8%; P=.08).Conclusion The noninvasive point-of-care assay for elevated urinary NMP22 protein can increase the ability to detect recurrent bladder cancer, with test results available during the patient visit.