DETERMINATION OF MOLECULAR TUMOR MARKER LEVELS HE4 (HUMAN EPIDIDYMIS PROTEIN 4) AND CA125 IN OVARIAN CANCERS”: A CROSS SECTIONAL STUDY

Abstract

BACKGROUND: The determination of molecular tumor markers HE4 (Human Epididymis Protein 4) and CA125 has become increasingly important for managing ovarian cancer. Ovarian cancer is asymptomatic, because it is often discovered at an advanced stage, and the death rate is increased. CA125 has been a traditional biomarker for ovarian cancer, but its limitations include false positives and poor sensitivity in early-stage disease.HE4, a newer biomarker, offers enhanced sensitivity and specificity, particularly when distinguishing benign gynecological disorders from ovarian cancer. Combining HE4 and CA125 biomarkers along with calculating the ‘Risk of ovarian malignancy algorithm’,‘ Risk malignancy index’enhances accuracy for diagnosis, facilitating better differentiation, whether the condition is malignant and non-malignant. This dual-marker approach also improves the monitoring of treatment response and early detection of recurrence, contributing to more effective clinical management and improved patient outcomes. AIMS: The overall aim of conducting the study is the evaluation of the molecular tumor markers level for those patients that have been diagnosed with ovarian tumors, notably CA125 and HE4 MATERIALS & METHODS: Women diagnosed with ovarian cancer, who had given consent for study underwent routine physical examination. Preoperative evaluations such as CA 125, and HE4 were done, and ROMA and the Risk malignancy index were calculated. “Elecsys CA 125 II and Elecsys HE4 test reagents” were used together with Cobas E 602 immunoassay analyzer to conduct the HE4 and CA 125 tests.Surgical intervention was done for patients with suspected ovarian malignancy, and sample was sent for histopathological examination. RESULTS:54 females were part of the study population.HE 4 achieves a slightly higher diagnostic accuracy (69.45%) compared to CA 125 (65.56%). Overall, these metrics suggest HE 4 may be slightly more effective as a diagnostic biomarker than CA 125.But,combining HE4 and CA125 for diagnosis and assessing treatment response demonstrates notable efficacy. xx This study reported that the sensitivity of this combination is 90.12%,specificity is 82.64%, and positive predictive value is 96.12% independently. The overall precision of diagnosis of the HE4 and CA125 combination stands at 69.25%. CONCLUSION: The determination ofHE4 and CA125 levels is vitalin early diagnosis, treatment, and prevention of ovarian cancer. By overcoming current limitations through strategic recommendations. It is possible to maximize these biomarkers' clinical utility, leading to better patient care and outcomes.