Lee Hyun Seok, Jeon Seong Woo, Nomura Sachiyo, Seto Yasuyuki, Kwon Yong Hwan, Nam Su Youn, Ishibashi Yuko, Ohtsu Hiroshi, Ohmoto Yasukazu, Yang Hae Min
Department of Internal Medicine, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, Republic of Korea.
Department of Gastrointestinal Surgery, Graduate School of Medicine, University of Tokyo, Tokyo, Japan.
Gastroenterol Res Pract. 2018 May 9;2018:1024074. doi: 10.1155/2018/1024074. eCollection 2018.
The serum pepsinogen test has limitation in its predictive power as a noninvasive biomarker for gastric cancer screening. We aimed to investigate whether the combination of TFF3 and pepsinogen could be an effective biomarker for the detection of gastric cancer even in the early stages.
In total, 281 patients with early gastric cancer (EGC), who underwent endoscopic submucosal dissection in Korea, and 708 healthy individuals from Japan were enrolled in the derivation cohort. The validation cohort included 30 Korean patients with EGC and 30 Korean healthy control blood donors. Serum TFF3 levels were examined using enzyme-linked immunosorbent assay.
Using a cutoff of 6.73 ng/mL in the derivation cohort, the sensitivity of the combination of tests for EGC detection was superior (87.5%) to that of TFF3 (80.4%) or pepsinogen test alone (39.5%). Similarly, in the validation cohort, the sensitivity of TFF3 plus pepsinogen was higher (90.4%) than that of TFF3 (80.0%) or pepsinogen test alone (33.3%).
The combination of serum TFF3 and pepsinogen is a more effective noninvasive biomarker for gastric cancer detection compared with pepsinogen or TFF3 alone, even in EGC. This trial is registered with NCT03046745.
血清胃蛋白酶原检测作为一种用于胃癌筛查的非侵入性生物标志物，其预测能力存在局限性。我们旨在研究三叶因子3（TFF3）与胃蛋白酶原的联合检测是否能成为一种有效的生物标志物，即使在早期阶段也能检测出胃癌。
在韩国，共有281例接受内镜黏膜下剥离术的早期胃癌（EGC）患者以及来自日本的708名健康个体被纳入推导队列。验证队列包括30例韩国EGC患者和30名韩国健康对照献血者。采用酶联免疫吸附测定法检测血清TFF3水平。
在推导队列中，以6.73 ng/mL为临界值，联合检测对EGC检测的敏感性（87.5%）高于单独检测TFF3（80.4%）或胃蛋白酶原（39.5%）。同样，在验证队列中，TFF3加胃蛋白酶原的敏感性（90.4%）高于单独检测TFF3（80.0%）或胃蛋白酶原（3,3.3%）。
血清TFF3与胃蛋白酶原的联合检测是一种比单独使用胃蛋白酶原或TFF3更有效的非侵入性胃癌检测生物标志物，即使在EGC中也是如此。本试验已在ClinicalTrials.gov注册，注册号为NCT03046745。
