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Background This study was conducted to evaluate the performance of human epididymal protein 4 (HE4), cancer antigen 125 (CA 125) and a combination of both via the Risk of Ovarian Malignancy Algorithm (ROMA) in detecting ovarian malignancy. Methods This was a diagnostic study enrolling 129 patients with pelvic mass(es) suspected of originating in the ovary who had been scheduled for surgery or radiological-guided biopsy. Serum HE4 and CA 125 levels were measured. HE4, CA 125 and ROMA were evaluated for sensitivity, specificity, positive predictive value and negative predictive value. The receiver operating characteristic (ROC) plots were graphed and area under the curve (AUC) values were calculated to investigate the accuracy of each marker for predicting ovarian malignancy. Results Overall, CA 125 remained significantly more sensitive (88.9% vs. 51.9%, p = 0.006) but less specific (56.9% vs. 95.1%, p &lt; 0.001) than HE4. HE4 was superior to CA 125 in specificity (97.7% vs. 54.5%, p &lt; 0.001) for premenopausal women. ROMA was non-significantly more sensitive (100.0% vs. 92.3%, p = 1.000) than CA 125 but both were equally specific (71.4%) for the postmenopausal group. In the premenopausal group, the AUC of serum HE4 was higher than serum CA 125 (0.851 vs. 0.817) but was equivalent to ROMA (0.851 vs. 0.859). In the postmenopausal group, ROMA exhibited an excellent AUC value as compared to CA 125 and HE4 (AUC of 0.907 vs. 0.874 vs. 0.863, respectively). Conclusion HE4 is useful in ruling out ovarian malignancy among premenopausal women. For postmenopausal women, ROMA appears to be an all-rounder with overall good sensitivity and specificity.

hormone molecular biology and clinical investigation

Evaluation in the predictive value of serum human epididymal protein 4 (HE4), cancer antigen 125 (CA 125) and a combination of both in detecting ovarian malignancy