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Background: This study aimed to determine the serum concentrations of CA125 and human epididymis protein 4 (HE4) in patients with ovarian cancer, and to evaluate the sensitivity and specificity of these biomarkers for differentiating between patients with benign gynecological disease and those with ovarian cancer, when used alone and in combination in a Korean population. Methods: We consecutively recruited 159 women with an adnexal mass, including 78 women with ovarian cancer. A total of 224 healthy women served as controls. The serum concentrations of HE4 and CA125 were analyzed using immunochemiluminescence assays. The concentrations of the markers were compared among the different subgroups, and the diagnostic accuracy of each marker and the combination of the two markers was assessed by plotting receiver operating characteristic (ROC) curves. In addition, the Risk of Ovarian Malignancy Algorithm (ROMA) was utilized to categorize patients into low- and high-risk groups for epithelial ovarian cancer. Results: Serum HE4 and CA125 concentrations were significantly higher in the ovarian cancer patients compared with those seen in patients with benign disease or in the healthy controls (p<0.0001 in both). In patients with an adnexal mass, the area under the ROC curve was higher when the combination of the markers was used compared with use of CA125 only. Using ROMA, patients could be successfully classified into high- and low-risk group, with 87.5% sensitivity at a specificity of 93.8%. Conclusions: These findings suggest that measuring serum HE4 concentrations along with CA125 concentrations may provide higher accuracy for detecting ovarian cancer. [ABSTRACT FROM AUTHOR]