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Clinical Chemistry and Laboratory Medicine (CCLM)

Published in Association with the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM)

Editor-in-Chief: Plebani, Mario

Ed. by Gillery, Philippe / Lackner, Karl J. / Lippi, Giuseppe / Melichar, Bohuslav / Payne, Deborah A. / Schlattmann, Peter / Tate, Jillian R.

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The ROMA (Risk of Ovarian Malignancy Algorithm) for estimating the risk of epithelial ovarian cancer in women presenting with pelvic mass: is it really useful?

1 / Elisa Danese1 / Orazio Ruzzenente1 / Valentina Bresciani2 / Teresita Nuzzo2 / Matteo Gelati1 / Gian Luca Salvagno1 / Massimo Franchi2 / Giuseppe Lippi3 / Gian Cesare Guidi1

1Clinical Biochemistry Laboratory, Department of Life and Reproduction Sciences, University Hospital of Verona, Verona, Italy

2Obstetrics and Gynecology Clinics, Department of Life and Reproduction Sciences, University Hospital of Verona, Verona, Italy

3Clinical Chemistry and Hematology Laboratory, Department of Pathology and Laboratory Medicine, University Hospital of Parma, Parma, Italy

Corresponding author: Dr. Martina Montagnana, Sezione di Biochimica Clinica, Dipartimento di Scienze della Vita e della Riproduzione, Ospedale Policlinico G.B. Rossi, Piazzale Scuro 10, Verona 37134, Italy Phone: +39-045-8126698, Fax: +39-045-8027484

Citation Information: Clinical Chemistry and Laboratory Medicine. Volume 49, Issue 3, Pages 521–525, ISSN (Online) 1437-4331, ISSN (Print) 1434-6621, DOI: 10.1515/CCLM.2011.075, February 2011

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Background: The study is aimed at evaluating the performance of the predictive model ROMA (Risk of Ovarian Malignancy Algorithm), which utilizes the combination of human epididymis protein 4 (HE4) and CA125 values to assess the risk of epithelial ovarian cancer (EOC) in women with a pelvic mass.

Methods: One hundred and four women diagnosed with a pelvic mass (55 EOC and 49 benign cases) and scheduled to have surgery were enrolled, along with 49 healthy females. Preoperative serum concentrations of HE4 and CA125 were measured. Separate logistic regression algorithms ROMA for pre-menopausal and post-menopausal women were used to categorize patients into low- and high-risk groups for EOC. The area under the curve (AUC), sensitivity and specificity were calculated for HE4, CA125 and ROMA for the diagnosis of ovarian cancer using receiver operating characteristic (ROC) analysis.

Results: The median CA125 and HE4 serum concentrations were significantly higher among EOC patients than in healthy females (both p<0.05) and those with a benign mass (both p<0.05). The pre-menopausal group included 36 benign cases (29 of which were classified by ROMA as low-risk with a specificity of 80.6%; 95% CI: 64.0%–91.8%), and 15 EOC (eight of which were classified by ROMA as high-risk, with a sensitivity of 53.3%; 95% CI: 26.6%–78.7%). The post-menopausal group enclosed 13 benign cases (11 of which were classified by ROMA as low-risk with a specificity of 84.6%; 95% CI: 54.6%–98.0%), and 40 EOC (33 of which were classified by ROMA as high-risk with a sensitivity of 82.5%; 95% CI: 67.2%–92.7%). In the pre-menopausal group, the AUC was 0.64 (p=0.12, 95% CI: 0.44–0.83) for CA125, 0.77 (p=0.003, 95% CI: 0.62–0.92) for HE4 and 0.77 (p=0.002, 95% CI: 0.63–0.92) for ROMA. In the post-menopausal group, the AUC was 0.84 (p=0.0003, 95% CI: 0.73–0.94) for CA125, 0.94 (p<0.0001, 95% CI: 0.88–0.99) for HE4 and 0.92 (p<0.0001, 95% CI: 0.85–0.99) for ROMA.

Conclusions: The ROMA is a simple scoring system which shows excellent diagnostic performance for the detection of EOC in post-menopausal women, but not in pre-menopausal women. Moreover, the dual marker combination of HE4 and CA125 (ROMA) does not show better performance than HE4 alone.

Keywords: biomarkers; CA125; epithelial ovarian cancer; human epididymis protein 4; pelvic mass

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