الفهرس 
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Abstract
The poor prognosis of ovarian cancer is attributed to the fact that the cancer is generally asymptomatic in the early stages and initial symptoms occur only during the late stage of the disease. Data from previous studies on the accuracy of serum CA125 and HE4 as well as ROMA in ovarian cancer diagnosis are contradictory. Thus, there is a pressing need to identify new tools with higher diagnostic accuracy for ovarian cancer diagnosis.
Purpose
The current study was conducted to evaluate the diagnostic accuracy of tissue CA125 and HE4 gene expression levels in comparison to serum CA125 and HE4 levels as well as ROMA in a cohort of Egyptian women with a pelvic mass.
Subjects and methods
1) A total of 100 Egyptian women were enrolled in this study, including 60 patients with epithelial ovarian cancer (EOC), 20 patients with benign ovarian tumors as well as 20 apparently healthy women.
2) Preoperative serum levels of CA125 and HE4 were measured by immunoassays.
3) The ROMA score was calculated based on CA125 and HE4 serum values using logistic regression analysis for premenopausal and postmenopausal women.
4) The mRNA expression levels of genes encoding CA125 and HE4 were determined in the normal, benign and malignant tissue specimens by quantitative real time polymerase chain reaction (qRT-PCR).
5) The diagnostic performance of CA125 and HE4, measured either as mRNA or protein levels, as well as that of ROMA, was evaluated by constructing a receiver operating characteristic (ROC) curve.
Results
1) Serum CA125+serum HE4 combination and serum HE4 as well as ROMA with AUC values of 0.935, 0.932 and 0.889, respectively, performed significantly better than serum CA125 alone (AUC=0.592; P<0.001) in distinguishing patients with EOC from those suffering from benign ovarian tumors.
2) Serum HE4 (AUC=0.932) and serum CA125+serum HE4 combination (AUC=0.935) yielded similar diagnostic accuracy (P=0.939).
3) Serum CA125+serum HE4 combination and serum HE4 with AUC values of 0.935 and 0.932, respectively, did not show better diagnostic performance than ROMA (AUC=0.889; P>0.05).
4) Tissue CA125 and HE4, either alone or in combination, performed significantly better than serum CA125 alone (AUC: 0.592 vs. 1; P<0.001), serum HE4 alone (AUC: 0.932 vs. 1; P=0.016) and serum CA125+serum HE4 combination (AUC: 0.935 vs. 1; P=0.018) as well as ROMA (AUC: 0.889 vs. 1; P=0.002).
Conclusion
Our findings strongly suggest that the measurement of tissue CA125 and HE4 gene expression levels, either alone or in combination, not only improves the discriminatory performance between benign and malignant pelvic masses, but also broadens the range of differential diagnostic possibilities for distinguishing EOC from benign ovarian tumors.