AIM: To develop and validate a biomarker-based index to optimize referral and diagnosis of patients with suspected ovarian cancer. Furthermore, to compare this new index with the Risk of Malignancy Index (RMI) and Risk of Ovarian Malignancy Algorithm (ROMA). PATIENTS AND METHODS: A training study, consisting of patients with benign ovarian disease (n=809) and ovarian cancer (n=246), was used to develop the Copenhagen Index (CPH-I) utilizing the variables serum HE4, serum CA125 and patient age. Eight international studies provided the validation population; comprising 1060 patients with benign ovarian masses and 550 patients with ovarian cancer. RESULTS: Overall, 2665 patients were included. CPH-I was highly significant in discriminating benign from malignant ovarian disease. At the defined cut-off of 0.070 for CPH-I the sensitivity and specificity were 95.0% and 78.4% respectively in the training cohort and 82.0% and 88.4% in the validation cohort. Comparison of CPH-I, ROMA and RMI demonstrated area-under-curve (AUC) at 0.960, 0.954 and 0.959 respectively in the training study and 0.951, 0.953 and 0.935 respectively in the validation study. Using a sensitivity of 95.0%, the specificities for CPH-I, ROMA and RMI in the training cohort were 78.4%, 71.7% and 81.5% respectively, and in the validation cohort 67.3%, 70.7% and 69.5% respectively. CONCLUSION: All three indices perform well at the clinically relevant sensitivity of 95%, but CPH-I, unlike RMI and ROMA, is independent of ultrasound and menopausal status, and may provide a simple index to optimize referral of women with suspected ovarian cancer.

• Klíčová slova
• Age, Biomarkers, CA125, CPH-I, Copenhagen Index, HE4, Ovarian cancer, Tumor markers,
• MeSH
• algoritmy MeSH
• antigen CA-125 krev   MeSH
• diferenciální diagnóza MeSH
• dospělí MeSH
• kohortové studie MeSH
• lidé středního věku MeSH
• lidé MeSH
• membránové proteiny krev   MeSH
• mladiství MeSH
• mladý dospělý MeSH
• multivariační analýza MeSH
• nádorové biomarkery krev   MeSH
• nádory vaječníků krev   diagnóza   patologie   MeSH
• nemoci ovaria krev   diagnóza   patologie   MeSH
• prospektivní studie MeSH
• protein WFDC2 MeSH
• proteiny metabolismus   MeSH
• senioři nad 80 let MeSH
• senioři MeSH
• statistické modely MeSH
• stupeň závažnosti nemoci MeSH
• věkové faktory MeSH
• Check Tag
• dospělí MeSH
• lidé středního věku MeSH
• lidé MeSH
• mladiství MeSH
• mladý dospělý MeSH
• senioři nad 80 let MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• multicentrická studie MeSH
• Názvy látek
• antigen CA-125 MeSH
• membránové proteiny MeSH
• MUC16 protein, human MeSH Prohlížeč
• nádorové biomarkery MeSH
• protein WFDC2 MeSH
• proteiny MeSH
• WFDC2 protein, human MeSH Prohlížeč