Abstract
Introduction: HE4 is a novel tumour biomarker used for early diagnosis of ovarian cancer. This study evaluated the diagnostic accuracy of HE4 alone and in combination with CA125, risk of malignancy index (RMI), risk of malignancy algorithm (ROMA). Methods: It was a cross sectional study conducted recruiting 88 women with adnexal masses who were planned for surgery. After baseline work up and ultrasound examination, serum samples were collected for estimation of CA 125 and HE4 levels. Serum HE4 levels were estimated using ELISA kit. RMI and ROMA score were calculated and diagnostic accuracy of HE4, CA 125, RMI, ROMA and their combination were compared. Cut off for HE4 and ROMA score were calculated using ROC curve. Results: Of 88 subjects, 66 were analyzed with 19 malignant (including 5 LMP) and 47 benign cases. The median value of HE4 among malignant cases was found to be significantly higher than among the benign cases. PPV and NPV of HE4 at a cut off 130.8 pMol/ml was 85.7% and 77.9% respectively. Highest PPV (88.9%) with acceptable NPV (80.7%) was found with ROMA followed by HE4 (PPV 85.7%; NPV 77.97%), RMI (PPV 76.92%; NPV 83%) and CA125 (PPV 52%; NPV 80.85%). Conclusion: HE4 levels were lower in Indian population both in malignant and benign tumours as compared to other studies. HE4 is a good discriminator and gives best accuracy when it is combined with CA125 in a logistic algorithm, ROMA.
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