Detection of bladder cancer using a point-of-care proteomic assay
Detection of bladder cancer using a point-of-care proteomic assay
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DOI：
10.1001/jama.293.7.810
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发表时间：
2005-02-16
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;Messing, E;Shen, Y
背景 膀胱癌的诊断需要结合使用多种方法，因为没有一种方法可以检测出所有恶性肿瘤。尿液检测通常是评估的一部分，但要么对癌症没有特异性，要么需要在实验室进行专门分析。 目的 研究测量排尿中核基质蛋白 NMP22 的即时蛋白质组学检测是否可以增强对具有膀胱癌危险因素或症状的患者的恶性肿瘤的检测。 设计、环境和患者 23 个学术、私人诊所和退伍军人设施 10个州前瞻性地从2001年9月到2002年5月连续招募了患者。参与者包括1331名因吸烟史或血尿和排尿困难等症状而罹患膀胱癌风险较高的患者。有泌尿道恶性肿瘤风险的患者在膀胱镜检查前提供了一份尿液样本，用于 NMP22 蛋白和细胞学分析。 主要结果指标 基于膀胱镜检查和活检的膀胱癌诊断被接受为参考标准。将 NMP22 测试的性能与排泄尿细胞学检查作为癌症检测的辅助手段进行比较。 NMP22肿瘤标志物检测采用盲法进行。结果79例患者确诊为膀胱癌。 79 名癌症患者中有 44 名 NMP22 检测呈阳性（敏感性，55.7%；95% 置信区间 [CI]，44.1%-66.7%），而 76 名患者中有 12 名细胞学检测结果呈阳性（敏感性，15.8%；95% CI，7.6%-24.0%）。 NMP22 检测的特异性为 85.7%（95% Cl，83.8%-87.6%），而细胞学检测的特异性为 99.2%（95% Cl，98.7%-99.7%）。蛋白质组标记物检测到 4 种初次内窥镜检查时未观察到的癌症，其中 3 种是肌肉浸润性癌症，1 种是原位癌。 结论 对尿 NMP22 蛋白升高进行非侵入性即时检测可提高膀胱镜检查的准确性，并在患者就诊期间提供测试结果。
Context A combination of methods is used for diagnosis of bladder cancer because no single procedure detects all malignancies. Urine tests are frequently part of an evaluation, but have either been nonspecific for cancer or required specialized analysis at a laboratory.Objective To investigate whether a point-of-care proteomic test that measures the nuclear matrix protein NMP22 in voided urine could enhance detection of malignancy in patients with risk factors or symptoms of bladder cancer.Design, Setting, and Patients Twenty-three academic, private practice, and veterans' facilities in 10 states prospectively enrolled consecutive patients from September 2001 to May 2002. Participants included 1331 patients at elevated risk for bladder cancer due to factors such as history of smoking or symptoms including hematuria and dysuria. Patients at risk for malignancy of the urinary tract provided a voided urine sample for analysis of NMP22 protein and cytology prior to cystoscopy.Main Outcome Measures The diagnosis of bladder cancer, 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 cancer detection. Testing for the NMP22 tumor marker was conducted in a blinded manner.Results Bladder cancer was diagnosed in 79 patients. The NMP22 assay was positive in 44 of 79 patients with cancer (sensitivity, 55.7%; 95% confidence interval [CI], 44.1%-66.7%), whereas cytology test results were positive in 12 of 76 patients (sensitivity, 15.8%; 95% Cl, 7.6%-24.0%). The specificity of the NMP22 assay was 85.7% (95% Cl, 83.8%-87.6%) compared with 99.2% (95% Cl, 98.7%-99.7%) for cytology. The proteomic marker detected 4 cancers that were not visualized during initial endoscopy, including 3 that were muscle invasive and 1 carcinoma in situ.Conclusion The noninvasive point-of-care assay for elevated urinary NMP22 protein can increase the accuracy of cystoscopy, with test results available during the patient visit.