Diagnostic Accuracy of Risk of Ovarian Malignancy Algorithm (ROMA) in Post-Menopausal Patients with Ovarian Mass.

Abstract

To determine the diagnostic accuracy of ROMA in postmenopausal women with history of ovarian mass. Observational study. Dr. Ziauddin University Hospital, Karachi, from May 2014 to June 2015. Two hundred and sixty postmenopausal women of 40-65 years of age with ovarian masses, planned for surgery, were included in the study. Their samples were obtained preoperatively and analysed on Abbot Architect i1000 SR immunoassay analyser for quantitative estimation of tumor markers, i.e. HE4 and CA125. By combination of these two tumor markers, ROMA scores were calculated and studied after histopathological verification of masses. Total number of patients were 260, out of which 122 (46.9%) were diagnosed as having ovarian cancer, while 138 (53.0%) were diagnosed as benign condition. Median ROMA score levels in patients with malignant masses were 95.58 (IQR=44.4) as compared to 20.6 (IQR=14) in benign masses. ROMA had sensitivity 92.6% (CI=86.47-96.04), specificity 78.3% (CI=70.09-83.82), positive predictive value 79% (CI=70.87-84.29), negative predictive value 92.3% (CI=86.02-95.9) and positive likelihood ratio 4.26, while negative likelihood ratio 0.1. Diagnostic accuracy of ROMA was 85%, based on ROC curve analysis. ROMA had the highest sensitivity in detecting ovarian carcinoma. ROMA is a very useful diagnostic tool for the preoperative stratification of patients with ovarian masses showing 85% diagnostic accuracy. However, there is need of more studies with homogenous laboratory procedures for HE4 and CA125 assays as well as patients, selection criteria, so we can draw firm conclusion about utility of ROMA in clinical setups.