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Assessing biological and technological variability in protein levels measured in pre-diagnostic plasma samples of women with breast cancer

机译：评估乳腺癌女性预诊断血浆样本中蛋白质水平的生物学和技术差异

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Background Quantitative proteomics allows for the discovery and functional investigation of blood-based pre-diagnostic biomarkers for early cancer detection. However, a major limitation of proteomic investigations in biomarker studies remains the biological and technical variability in the analysis of complex clinical samples. Moreover, unlike ‘omics analogues such as genomics and transcriptomics, proteomics has yet to achieve reproducibility and long-term stability on a unified technological platform. Few studies have thoroughly investigated protein variability in pre-diagnostic samples of cancer patients across multiple platforms. Methods We obtained ten blood plasma “case” samples collected up to 2 years prior to breast cancer diagnosis. Each case sample was paired with a matched control plasma from a full biological sister without breast cancer. We measured protein levels using both mass-spectrometry and antibody-based technologies to: (1) assess the technical considerations in different protein assays when analyzing limited clinical samples, and (2) evaluate the statistical power of potential diagnostic analytes. Results Although we found inherent technical variation in the three assays used, we detected protein dependent biological signal from the limited samples. The three assay types yielded 32 proteins with statistically significantly ( p Conclusions Technical, practical, and study design considerations are essential to maximize information obtained in limited pre-diagnostic samples of cancer patients. This study provides a framework that estimates biological effect sizes critical for consideration in designing studies for pre-diagnostic blood-based biomarker detection.
机译：背景技术定量蛋白质组学可用于基于血液的预诊断生物标记物的发现和功能研究，以用于早期癌症检测。但是，蛋白质组学研究在生物标志物研究中的主要局限性在于复杂临床样品分析中的生物学和技术变异性。此外，蛋白质组学与诸如基因组学和转录组学之类的组学类似物不同，尚未在统一的技术平台上实现可重复性和长期稳定性。很少有研究对跨多个平台的癌症患者的预诊断样本中的蛋白质变异性进行深入研究。方法我们获得了在乳腺癌诊断之前2年收集的10个血浆“病例”样本。每个病例样品与来自没有乳腺癌的完整生物学姐妹的匹配对照血浆配对。我们使用质谱法和基于抗体的技术测量蛋白质水平，以：（1）在分析有限的临床样本时评估不同蛋白质测定法中的技术考虑，以及（2）评估潜在诊断分析物的统计能力。结果尽管我们在所使用的三种测定法中发现了固有的技术差异，但我们从有限的样品中检测到了蛋白质依赖性生物学信号。三种检测方法产生的32种蛋白质具有统计学上的显着性（p结论技术，实用和研究设计方面的考虑因素对于最大化癌症患者有限的预诊断样本中获得的信息至关重要。在设计用于基于血液的预诊断生物标志物检测的研究中。

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