Wang Haixia, Zhu Jianqing, Zou Dongling, Rao Qunxian, Han Liping, Lu Huaiwu, Wang Junjian, Liu Liya, Ma Lifang, Sun Lu, Yi Lin, Feng Wenlong, Zhang Yanan, Du Ye, Yang Min, Feng Yan, Zhang Dadong, Lin Zhongqiu, Zhou Qi
Department of Gynecologic Oncology, Chongqing University Cancer Hospital & Chongqing Cancer Institute & Chongqing Cancer Hospital, Chongqing, China; Chongqing Specialized Medical Research Center of Ovarian Cancer, Chongqing, China; Organoid Transformational Research Center, Chongqing Key Laboratory for the Mechanism and Intervention of Cancer Metastasis, Chongqing University Cancer Hospital, Chongqing, China.
Department of Gynecologic Oncology, Zhejiang Cancer Hospital, Hangzhou, China.
Gynecol Oncol. 2025 Feb;193:58-64. doi: 10.1016/j.ygyno.2024.12.017. Epub 2025 Jan 9.
Early detection is crucial for improving survival of patients with ovarian cancer (OC), yet current diagnostic tools lack adequate sensitivity and specificity, especially for early stage disease. The study aimed to validate the serum small extracellular vesicles (sEV) protein based Ovarian Cancer Score (OCS) in detecting OC.
This multicenter study included 1183 adult females with adnexal masses from four hospitals in China (October 2019-April 2023). Of these, 1024 samples were prospectively collected, and 159 were from biobanks. All serum samples were collected before surgery. The concentrations of sEV carbohydrate antigen 125 (CA125), human epididymis protein 4 (HE4), and complement component 5a protein (C5a) were quantified using chemiluminescence immunoassay and then used for calculating OCS. Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were calculated.
The OCS demonstrated high sensitivity (95.4 %) and specificity (90.4 %) in diagnosis of OC in the prospective cohort (n = 1024) and in total cases (n = 1183, 95.5 % and 90.2 %), with stable performance across menopausal status and FIGO stages. The OCS maintained a high specificity in premenopausal patients (89.6 %) and postmenopausal patients (92.1 %). The OCS showed high sensitivity in early stage epithelial OC (FIGO I: 89.7 %, I + II: 91.4 %), in patients aged ≤45 years (92.7 %), and in patients with normal CA125 levels (72.7 %), although these results were obtained from subgroups with small sample sizes.
This multicenter study demonstrated that the OCS is a promising non-invasive diagnostic tool for the detection of OC.
This study was registered at ClinicalTrials.gov: NCT06366997.
早期检测对于提高卵巢癌（OC）患者的生存率至关重要，但目前的诊断工具缺乏足够的敏感性和特异性，尤其是对于早期疾病。本研究旨在验证基于血清小细胞外囊泡（sEV）蛋白的卵巢癌评分（OCS）在检测OC中的作用。
这项多中心研究纳入了来自中国四家医院的1183名患有附件肿块的成年女性（2019年10月至2023年4月）。其中，前瞻性收集了1024份样本，159份来自生物样本库。所有血清样本均在手术前采集。使用化学发光免疫分析法对sEV糖类抗原125（CA125）、人附睾蛋白4（HE4）和补体成分5a蛋白（C5a）的浓度进行定量，然后用于计算OCS。计算敏感性、特异性、阳性预测值（PPV）和阴性预测值（NPV）。
OCS在前瞻性队列（n = 1024）和所有病例（n = 1183，95.5%和90.2%）中对OC诊断显示出高敏感性（95.4%）和特异性（90.4%），在绝经状态和国际妇产科联盟（FIGO）分期中表现稳定。OCS在绝经前患者（89.6%）和绝经后患者（92.1%）中保持高特异性。OCS在早期上皮性OC（FIGO I：89.7%，I + II：91.4%）、年龄≤45岁的患者（92.7%）以及CA125水平正常的患者（72.7%）中显示出高敏感性，尽管这些结果来自样本量较小的亚组。
这项多中心研究表明，OCS是一种有前景的用于检测OC的非侵入性诊断工具。
本研究已在ClinicalTrials.gov注册：NCT06366997。
