Analytical validation of serum proteomic profiling for diagnosis of prostate cancer: Sources of sample bias
Analytical validation of serum proteomic profiling for diagnosis of prostate cancer: Sources of sample bias
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DOI：
10.1373/clinchem.2007.091470
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发表时间：
2008-01-01
影响因子：
9.3
通讯作者：
Semmes, O. John
中科院分区：
文献类型：
--
作者：
McLerran, Dale;Grizzle, William E.;Semmes, O. John
背景技术背景：本报告和配套报告描述了通过SELDI-TOF质谱法检测前列腺癌的血清蛋白质组学分析的能力的验证。已经描述了该3阶段过程的细节。本文介绍了第一阶段盲法试验的算法和结果。方法：我们通过分析前列腺癌（n = 181）、良性前列腺增生（BPH）（n = 143）和正常对照组（n = 220）的血清样本推导出本研究中使用的决策算法。我们还从来自42名前列腺癌患者和42名无前列腺癌对照的一组单独的、地理上不同的血清样本中推导出了一个验证测试集。等分试样进行随机化和盲法分析，并从每个实验室网站的数据进行决策算法和decoded.RESULTS：使用从验证测试集收集的数据，决策算法是不成功的，在分离癌症与任何预测效用的控制。实验数据的分析揭示了潜在的来源bias.CONCLUSION：决策算法的能力，成功地区分前列腺癌，BPH，和控制样品使用来自血清蛋白质谱的数据受到损害的偏见。(c)2007年美国临床化学协会。
BACKGROUND: This report and a companion report describe a validation of the ability of serum proteomic profiling via SELDI-TOF mass spectrometry to detect prostatic cancer. Details of this 3-stage process have been described. This report describes the development of the algorithm and results of the blinded test for stage 1.METHODS: We derived the decision algorithm used in this study from the analysis of serum samples from patients with prostate cancer (n = 181) and benign prostatic hyperplasia (BPH) (n 143) and normal controls (n = 220). We also derived a validation test set from a separate, geographically diverse set of serum samples from 42 prostate cancer patients and 42 controls without prostate cancer. Aliquots were subjected to randomization and blinded analysis, and data from each laboratory site were subjected to the decision algorithm and decoded.RESULTS: Using the data collected from the validation test set, the decision algorithm was unsuccessful in separating cancer from controls with any predictive utility. Analysis of the experimental data revealed potential sources of bias.CONCLUSION: The ability of the decision algorithm to successfully differentiate between prostate cancer, BPH, and control samples using data derived from serum protein profiling was compromised by bias. (c) 2007 American Association for Clinical Chemistry.