• Obstetrics and gynecology · Aug 2011

    Multicenter Study Clinical Trial

    Evaluation of the diagnostic accuracy of the risk of ovarian malignancy algorithm in women with a pelvic mass.

    • Richard G Moore, M Craig Miller, Paul Disilvestro, Lisa M Landrum, Walter Gajewski, John J Ball, and Steven J Skates.
    • Department of Obstetrics and Gynecology and the Center for Biomarkers and Emerging Technologies, Program in Women's Oncology, Women and Infants' Hospital, Brown University, Providence, Rhode Island 02925, USA. rmoore@wihri.org
    • Obstet Gynecol. 2011 Aug 1; 118 (2 Pt 1): 280-8.

    ObjectiveIt is often difficult to distinguish a benign pelvic mass from a malignancy and tools to help referring physician are needed. The purpose of this study was to validate the Risk of Ovarian Malignancy Algorithm in women presenting with a pelvic mass.MethodsThis was a prospective, multicenter, blinded clinical trial that included women who presented to a gynecologist, a family practitioner, an internist, or a general surgeon with an adnexal mass. Serum HE4 and CA 125 were determined preoperatively. A Risk of Ovarian Malignancy Algorithm score was calculated and classified patients into high-risk and low-risk groups for having a malignancy. The sensitivity, specificity, negative predictive value, and positive predictive value of the Risk of Ovarian Malignancy Algorithm were estimated.ResultsA total of 472 patients were evaluated with 383 women diagnosed with benign disease and 89 women with a malignancy. The incidence of all cancers was 15% and 10% for ovarian cancer. In the postmenopausal group, a sensitivity of 92.3% and a specificity of 76.0% and for the premenopausal group the Risk of Ovarian Malignancy Algorithm had a sensitivity of 100% and specificity of 74.2% for detecting ovarian cancer. When considering all women together, the Risk of Ovarian Malignancy Algorithm had a sensitivity of 93.8%, a specificity of 74.9%, and a negative predictive value of 99.0%.ConclusionThe use of the serum biomarkers HE4 and CA 125 with the Risk of Ovarian Malignancy Algorithm has a high sensitivity for the prediction of ovarian cancer in women with a pelvic mass. These findings support the use of the Risk of Ovarian Malignancy Algorithm as a tool for the triage of women with an adnexal mass to gynecologic oncologists.Level Of EvidenceII.

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