Journal of clinical laboratory analysis · 2026
Application of Serum CA125, HE4, ROMA, and CPH-I in the Preoperative Differentiation of Ovarian Tumors: A Diagnostic Accuracy Study.
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Feng Weiming, Zhang Chunying, Meng Lingxin, Chen Yifei, Yu Haiyun, Zhai Yanhong, Cao Zheng
Аннотация
OBJECTIVE: This study aimed to compare the diagnostic accuracy of four serum biomarkers-carbohydrate antigen 125 (CA125), human epididymis protein 4 (HE4), the Risk of Ovarian Malignancy Algorithm (ROMA), and the Copenhagen Index (CPH-I)-for the preoperative discrimination of benign/borderline from malignant ovarian cancer, with particular attention to menopausal status.
METHODS: A retrospective study enrolled 345 patients with histologically confirmed ovarian tumors (187 benign/borderline; 158 malignant). Serum CA125 and HE4 were measured and reported by the electrochemiluminescence immunoassays, along with the calculated indices of ROMA and CPH-I. Diagnostic performance was assessed by the area under the curve (AUC), sensitivity, and specificity, respectively.
RESULTS: Among the 158 ovarian tumors patients, CPH-I demonstrated superior discriminative capacity with the highest AUC (0.924), followed by ROMA (0.916), HE4 (0.897), and CA125 (0.865). Menopausal stratification identified CPH-I as optimal for premenopausal women (AUC 0.886) and ROMA for postmenopausal women (AUC 0.928). ROMA exhibited the highest overall sensitivity (84.8%), whereas CA125 achieved the highest overall specificity (94.1%). In premenopausal patients, HE4 demonstrated exceptional specificity (98.6%), while postmenopausal women showed equivalent specificity between HE4 and CPH-I (both 97.8%). In combined panels, CA125 + HE4 + CPH-I yielded the highest overall accuracy (AUC 0.925), and CA125 + HE4 + ROMA provided optimal postmenopausal performance (AUC 0.930).
CONCLUSIONS: CPH-I demonstrated favorable diagnostic performance compared with conventional biomarkers. Our findings advocate for a menopausal status-guided clinical algorithm, utilizing a CPH-I-based panel for premenopausal women and a ROMA-based panel for postmenopausal women to maximize diagnostic precision.
METHODS: A retrospective study enrolled 345 patients with histologically confirmed ovarian tumors (187 benign/borderline; 158 malignant). Serum CA125 and HE4 were measured and reported by the electrochemiluminescence immunoassays, along with the calculated indices of ROMA and CPH-I. Diagnostic performance was assessed by the area under the curve (AUC), sensitivity, and specificity, respectively.
RESULTS: Among the 158 ovarian tumors patients, CPH-I demonstrated superior discriminative capacity with the highest AUC (0.924), followed by ROMA (0.916), HE4 (0.897), and CA125 (0.865). Menopausal stratification identified CPH-I as optimal for premenopausal women (AUC 0.886) and ROMA for postmenopausal women (AUC 0.928). ROMA exhibited the highest overall sensitivity (84.8%), whereas CA125 achieved the highest overall specificity (94.1%). In premenopausal patients, HE4 demonstrated exceptional specificity (98.6%), while postmenopausal women showed equivalent specificity between HE4 and CPH-I (both 97.8%). In combined panels, CA125 + HE4 + CPH-I yielded the highest overall accuracy (AUC 0.925), and CA125 + HE4 + ROMA provided optimal postmenopausal performance (AUC 0.930).
CONCLUSIONS: CPH-I demonstrated favorable diagnostic performance compared with conventional biomarkers. Our findings advocate for a menopausal status-guided clinical algorithm, utilizing a CPH-I-based panel for premenopausal women and a ROMA-based panel for postmenopausal women to maximize diagnostic precision.