Trial on five plasma biomarkers (CA125, HE4, OPN, leptin, prolactin) and their possible role in differentiating benign from malignant ovarian tumors. In this unicentric prospective trial preoperative blood samples of 43 women with ovarian masses determined for ovarian surgery were analyzed. 25 patients had pathologically confirmed benign, 18 malignant ovarian tumors. Blood plasma was analyzed for CA125, HE4, OPN, leptin, prolactin and MIF by multiplex immunoassay analysis. Each single protein and a logistical regression model including all the listed proteins were tested as preoperative predictive marker for suspect ovarian masses. Plasma CA125 was confirmed as a highly accurate tumor marker in ovarian cancer. HE4, OPN, leptin and prolactin plasma levels differed significantly between benign and malignant ovarian masses. With a logistical regression model a formula including CA125, HE4, OPN, leptin and prolactin was developed to predict malignant ovarian tumors. With a discriminatory AUC of 0.96 it showed to be a highly sensitive and specific diagnostic test for a malignant ovarian tumor. The calculated formula with the combination of CA125, HE4, OPN, leptin and prolactin plasma levels surpasses each single marker in its diagnostic value to discriminate between benign and malignant ovarian tumors. The formula, applied to our patient population was highly accurate but should be validated in a larger cohort. Clinical Trials.gov under NCT01763125 , registered Jan. 8, 2013.

中文翻译：

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基于患者血浆中五种蛋白质特征的上皮性卵巢癌生物标志物早期检测——一项前瞻性试验


对五种血浆生物标志物（CA125、HE4、OPN、瘦素、催乳素）的试验及其在区分良性和恶性卵巢肿瘤中的可能作用。在这项单中心前瞻性试验中，对 43 名患有卵巢肿块且需要进行卵巢手术的女性的术前血液样本进行了分析。病理证实卵巢良性肿瘤25例，恶性肿瘤18例。通过多重免疫分析分析血浆中的 CA125、HE4、OPN、瘦素、催乳素和 MIF。每个单一蛋白质和包括所有列出的蛋白质的逻辑回归模型都被测试作为可疑卵巢肿块的术前预测标记。血浆CA125被证实是卵巢癌中高度准确的肿瘤标志物。良性和恶性卵巢肿块之间的 HE4、OPN、瘦素和催乳素血浆水平存在显着差异。通过逻辑回归模型，建立了一个包含 CA125、HE4、OPN、瘦素和催乳素的公式来预测卵巢恶性肿瘤。它的区分性 AUC 为 0.96，被证明是一种对恶性卵巢肿瘤具有高度敏感性和特异性的诊断测试。结合CA125、HE4、OPN、瘦素和催乳素血浆水平计算得出的公式在区分良性和恶性卵巢肿瘤的诊断价值上超过了单个标志物。该公式适用于我们的患者群体，非常准确，但应该在更大的队列中进行验证。 Clinical Trials.gov 下的 NCT01763125，注册于 2013 年 1 月 8 日。