Background:Colorectal cancer (CRC) is a leading cause of death worldwide. Despite its preventability through screening, compliance still needs to improve due to the invasiveness of current tools. There is a growing demand for validated molecular biomarker panels for minimally invasive blood-based CRC screening. This study assessed the diagnostic accuracy of four promising blood-based CRC biomarkers, individually and in combination.Methods:This case–control study involved plasma samples from 124 CRC cases and 124 age- and sex-matched controls. Biomarkers tested included methylated DNA encoding the Septin-9 gene (mSEPT9) using Epi proColon®2.0 CE, insulin-like growth factor binding protein 2 (IGFBP2), dickkopf-3 (DKK3), and pyruvate kinase M2 (PKM2) by ELISA. Diagnostic accuracy was measured using the receiver operating characteristic (ROC), area under the curve (AUC), as well as sensitivity and specificity.Results:Diagnostic accuracy formSEPT9, IGFBP2, DKK3, and PKM2 was 62.9% (95% CI: 56.8–62.9%), 69.7% (95% CI: 63.1–69.7%), 61.6% (95% CI: 54.6–61.6%), and 50.8% (95% CI: 43.4–50.8%), respectively. The combined biomarkers yielded an AUC of 74.4% (95% CI: 68.1–80.6%), outperforming all biomarkers except IGFBP2.Conclusions:These biomarkers show potential for developing a minimally invasive CRC detection tool as an alternative to existing approaches, potentially increasing adherence, early detection, and survivorship.
背景：结直肠癌是全球主要的致死原因之一。尽管通过筛查可以预防，但由于现有检查工具的侵入性，筛查依从性仍有待提高。市场对经过验证的微创血液结直肠癌筛查分子标志物组合的需求日益增长。本研究评估了四种有前景的血液结直肠癌生物标志物单独及联合应用的诊断效能。 方法：本病例对照研究纳入了124例结直肠癌患者和124例年龄性别匹配对照者的血浆样本。检测的生物标志物包括：使用Epi proColon®2.0 CE检测的Septin-9基因甲基化DNA（mSEPT9），以及通过ELISA法检测的胰岛素样生长因子结合蛋白2（IGFBP2）、dickkopf-3（DKK3）和丙酮酸激酶M2（PKM2）。采用受试者工作特征曲线、曲线下面积以及敏感性和特异性评估诊断效能。 结果：mSEPT9、IGFBP2、DKK3和PKM2的诊断准确率分别为62.9%（95% CI：56.8-62.9%）、69.7%（95% CI：63.1-69.7%）、61.6%（95% CI：54.6-61.6%）和50.8%（95% CI：43.4-50.8%）。联合标志物的曲线下面积为74.4%（95% CI：68.1-80.6%），其诊断效能优于除IGFBP2外的所有单一标志物。 结论：这些生物标志物显示出开发微创结直肠癌检测工具的潜力，可作为现有筛查方法的替代方案，有望提高筛查依从性、实现早期检测并改善患者生存预后。
Diagnostic Accuracy of a Blood-Based Biomarker Panel for Colorectal Cancer Detection: A Pilot Study
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