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A Serum MicroRNA Biomarker Panel for Detection of Gastric Cancer

机译：用于检测胃癌的血清MicroRNA生物标志物组

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BACKGROUND AND AIM: Gastric cancer is the 2nd leading cause of cancer deaths worldwide. Currently, endoscopy is the only reliable method for early diagnosis. However, the invasiveness and cost limit its usage as a screening test. MicroRNAs (miRNAs) are important regulator of cancer pathogenesis and are exceptionally stable in body fluids. This study aimed to identify a serum miRNA panel as biomarker for minimally-invasive detection of gastric cancer. METHODS: We performed a multi-center, retrospective study including 682 high risk and gastric cancer subjects. In the Singaporean discovery cohort, 578 miRNAs were quantified using qPCR in the sera of 236 gastric cancer subjects and 236 matched high risk subjects. A 24-miR biomarker panel was formulated and used for blinded validation in a Korean (n = 121) and a Singaporean (n = 89) case-control cohort. RESULTS: 191 miRNAs were reliably detected in all serum samples, among which 75 were significantly altered (P-value<0.01 after FDR) between gastric cancer and high risk subjects. A 24-miR model was optimized based on the discovery cohort (AUC = 0.92] and validated in two blinded studies with fixed algorithm and threshold cutoff. The panel showed 90% sensitivity and 81% specificity in the Korean cohort (AUC = 0.91] and had 90% sensitivity and 75% specificity in the Singaporean cohort (AUC = 0.89). Importantly, the 24-miR panel was able to detect stage 1 and 2 gastric cancer in both Korean [AUC = 0.88] and Singaporean (AUC = 0.91) cohorts. Cost-effectiveness analysis showed that there is significant cost saving in comparison to the current clinical practice. CONCLUSIONS: We have identified a serum miRNA panel which can differentiate patients with various stage gastric cancer from high risk controls. It may serve as a minimally-invasive screening test for gastric cancer prior to endoscopy.
机译：背景与目的：胃癌是全球癌症死因的第二名。目前，内窥镜检查是早期诊断的唯一可靠方法。但是，侵入性和成本将其用途限制为筛选测试。 microRNAs（miRNA）是癌症发病机制的重要调节因子，并且在体液中具有异常稳定。本研究旨在鉴定血清miRNA面板作为生物标志物，用于微创检测胃癌。方法：我们进行了多中心，回顾性研究，包括682种高风险和胃癌受试者。在新加坡发现队列中，使用QPCR在236例胃癌受试者的血清中量化了578 miRNA，236种匹配的高风险受试者。制定了24立方米生物标志物面板，并用于韩国（n = 121）和新加坡人（n = 89）病例对照队列的盲验证。结果：在所有血清样品中可靠地检测到191个miRNA，其中75在胃癌和高风险受试者之间显着改变75（FDR后的P值<0.01）。基于发现群组（AUC = 0.92]进行了优化了24 MiR模型，并以固定算法和阈值截止的两个盲化研究验证。该面板在韩国队列（AUC = 0.91]中显示了90％的灵敏度和81％的特异性在新加坡队列（AUC = 0.89）中有90％的灵敏度和75％的特异性。重要的是，24-miR面板能够在韩国[AUC = 0.88]和新加坡人（AUC = 0.91）中检测阶段1和2胃癌与当前的临床实践相比，成本效益分析表明，与目前的临床实践相比，节省了显着的成本。结论：我们已经确定了一种血清MiRNA面板，可以将患有各种阶段胃癌的患者与高风险控制分化。它可以作为最低限度 - 在内窥镜检查前胃癌的筛查试验。

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