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Clinical Trial
. 2011 Aug;118(2 Pt 1):280-288.
doi: 10.1097/AOG.0b013e318224fce2.

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

Richard G Moore  1 , M Craig Miller, Paul Disilvestro, Lisa M Landrum, Walter Gajewski, John J Ball, Steven J Skates
Affiliations
Clinical Trial

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

Richard G Moore et al. Obstet Gynecol. 2011 Aug.

Abstract

Objective: It 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.

Methods: This 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.

Results: A 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%.

Conclusion: The 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 evidence: II.

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Conflict of interest statement

The other authors did not report any potential conflicts of interest.

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