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.