Significantly elevated serum human epididymis protein‐4 in chronic kidney disease patients without ovarian cancer: A large‐scale retrospective study

BACKGROUNDS: Human epididymis protein‐4 (HE‐4) is a commonly used biomarker for diagnosing ovarian cancer. Elevated HE‐4 has also been observed in various benign conditions including chronic kidney disease (CKD); however, generalizability and statistical power of previous studies have been limited by small sample sizes. MATERIALS AND METHODS: We conducted a retrospective study that included 80 pathologically confirmed ovarian cancer patients, 641 CKD patients, and 2661 healthy controls. Serum HE‐4 and several renal function parameters were collected and compared between the three groups. Correlation analysis was conducted to evaluate the relationship between HE‐4 and renal function parameters. A receiver operating characteristic curve was established to evaluate its diagnostic performance. RESULTS: CKD patients had the highest levels of HE‐4, with a median of 193.00 pmol/L, while the median in ovarian cancer patients was 90.82 pmol/L. HE‐4 levels also increased with CKD progression, and Spearman's rank correlation showed that HE‐4 had a strong correlation with renal function parameters in CKD patients. Furthermore, HE‐4 exhibited a satisfactory diagnostic performance in both differentiating CKD patients and controls as well as stage 2 CKD patients and controls. CONCLUSION: HE‐4 can be used as an alternative biomarker for diagnosing CKD as it is less affected by several preanalytical factors. Nevertheless, in clinical practice, elevated HE‐4 requires taking both CKD and ovarian cancer into consideration.