To investigate the diagnostic value of human epididymis protein (HE4) and carbohydrate antigen-125 (CA₁₂₅) in ovarian cancer.

From January 2009 to August 2010, 59 women with pelvic mass were included into this study. They were divided into two groups according to pathological examination after operation, ovarian cancer group (n=29) and pelvic benign diseases groups (n=30). Meanwhile, another 37 healthy women who had the physical examination during the same period were recruited into control group. The study protocol was approved by the Ethical Review Board of Investigation in Human Being of West China Second University Hospital, Sichuan University. Informed consent was obtained from all participants. The single and combined detection of HE4 and CA₁₂₅ levels in the serum from three groups were quantitatively determined by enzyme-linked immunosorbent assay (ELISA) and chemiluminescence immunoassay (CLIA). At last, the area under curve (AUC) of the total results were evaluated by receiver operating characteristic curve (ROC).

Serum HE4 and CA₁₂₅ levels in ovarian cancer group were significantly higher than those in other two groups with statistically significant difference (P<0.01, P<0.05). There was no significant difference between pelvic benign disease group and control group in the serum HE4 level (P>0.05). Reference to benign disease group(AUC=1), the correspondence AUC by ROC of HE4, CA₁₂₅ and the both indexes were 0.924, 0.793 and 0.931, respectively, and the cut off value of HE4 and CA₁₂₅ in clinical diagnosis was 73.5 pmol/L and 35 IU/mL, respectively.

Combined detection of HE4 and CA₁₂₅ could improve the sensitivity and efficiency in the diagnosis of early ovarian cancer.