开发并验证一种高灵敏度的基于尿液的检测方法，以识别患有结肠腺瘤性息肉的患者。
Development and validation of a highly sensitive urine-based test to identify patients with colonic adenomatous polyps.
机构信息
Division of Gastroenterology, University of Alberta, Edmonton, Alberta, Canada.
出版信息
Clin Transl Gastroenterol. 2014 Mar 20;5(3):e54. doi: 10.1038/ctg.2014.2.
OBJECTIVES
Adenomatous polyps are precursors of colorectal cancer; their detection and removal is the goal of colon cancer screening programs. However, fecal-based methods identify patients with adenomatous polyps with low levels of sensitivity. The aim or this study was to develop a highly accurate, prototypic, proof-of-concept, spot urine-based diagnostic test using metabolomic technology to distinguish persons with adenomatous polyps from those without polyps.
METHODS
Prospective urine and stool samples were collected from 876 participants undergoing colonoscopy examination in a colon cancer screening program, from April 2008 to October 2009 at the University of Alberta. Colonoscopy reference standard identified 633 participants with no colonic polyps and 243 with colonic adenomatous polyps. One-dimensional nuclear magnetic resonance spectra of urine metabolites were analyzed to define a diagnostic metabolomic profile for colonic adenomas. A urine metabolomic diagnostic test for colonic adenomatous polyps was established using 67% of the samples (un-blinded training set) and validated using the other 33% of the samples (blinded testing set). The urine metabolomic diagnostic test's specificity and sensitivity were compared with those of fecal-based tests.
RESULTS
Using a two-component, orthogonal, partial least-squares model of the metabolomic profile, the un-blinded training set identified patients with colonic adenomatous polyps with 88.9% sensitivity and 50.2% specificity. Validation using the blinded testing set confirmed sensitivity and specificity values of 82.7% and 51.2%, respectively. Sensitivities of fecal-based tests to identify colonic adenomas ranged from 2.5 to 11.9%.
CONCLUSIONS
We describe a proof-of-concept spot urine-based metabolomic diagnostic test that identifies patients with colonic adenomatous polyps with a greater level of sensitivity (83%) than fecal-based tests.
目的
腺瘤性息肉是结直肠癌的前体；它们的检测和切除是结直肠癌筛查计划的目标。然而，基于粪便的方法对腺瘤性息肉的检测灵敏度较低。本研究旨在开发一种高度准确、原型、概念验证、基于点尿的代谢组学诊断测试，以区分有和无腺瘤性息肉的患者。
方法
前瞻性收集 876 名参加结直肠癌筛查计划的参与者的尿液和粪便样本，这些参与者于 2008 年 4 月至 2009 年 10 月在阿尔伯塔大学接受结肠镜检查。结肠镜检查参考标准确定了 633 名无结肠息肉的参与者和 243 名有结肠腺瘤性息肉的参与者。分析尿液代谢物的一维核磁共振谱，以定义结肠腺瘤的诊断代谢组学特征。使用 67%的样本（未盲训练集）建立了用于结肠腺瘤性息肉的尿液代谢组学诊断测试，并使用其余 33%的样本（盲测试集）进行验证。将尿液代谢组学诊断测试的特异性和灵敏度与粪便测试进行比较。
结果
使用代谢组学特征的两成分正交偏最小二乘模型，未盲训练集确定结肠腺瘤性息肉患者的灵敏度为 88.9%，特异性为 50.2%。使用盲测试集进行验证，确认了灵敏度和特异性值分别为 82.7%和 51.2%。基于粪便的测试识别结肠腺瘤的灵敏度范围为 2.5%至 11.9%。
结论
我们描述了一种概念验证的基于点尿的代谢组学诊断测试，该测试对结肠腺瘤性息肉的识别灵敏度（83%）高于基于粪便的测试。
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