OBJECTIVE: The American College of Obstetricians and Gynecologists (the College) published referral guidelines for @entity1 with a pelvic mass that incorporate @entity10224 . A new multivariate index assay assesses the malignant risk of @entity43 before surgery. Our objective was to estimate the performance of the College guidelines with this new multivariate index assay. METHODS: This prospective, multi-institutional trial included 27 primary care and specialty sites throughout the United States. The College guidelines were evaluated in @entity1 scheduled for surgery for an ovarian mass. Clinical criteria and blood for biomarkers were collected before surgery. A standard @entity10224 -II assay was used and the value applied to the multivariate index assay algorithm and the @entity10224 analysis. Study results were correlated with surgical pathology. RESULTS: Of the 590 @entity1 enrolled with ovarian mass on pelvic imaging, 516 were evaluable. There were 161 @entity5 (45 premenopausal and 116 postmenopausal). The College referral criteria had a modest sensitivity in detecting @entity5 . Replacing @entity10224 with the multivariate index assay increased the sensitivity (77-94%) and negative predictive value (87-93%) while decreasing specificity (68-35%) and positive predictive value (52-40%). Similar trends were noted for premenopausal @entity1 and early-stage disease. CONCLUSION: Replacing @entity10224 with the multivariate index assay improves the sensitivity and negative predictive value of the College referral guidelines while decreasing specificity and positive predictive value. The high sensitivity is maintained in premenopausal @entity1 and early-stage disease.

Performance of the American College of Obstetricians and Gynecologists' XXXX referral guidelines with a multivariate index assay.

@entity1 :: ('9606', 'Species') :: ['women'] @entity43 :: ('MESH:D010051', 'Disease') :: ['ovarian tumors'] @entity5 :: ('MESH:D009369', 'Disease') :: ['malignancy', 'malignancies'] @entity10224 :: ('94025', 'Gene') :: ['CA 125']
@entity43 :: (MESH:D010051,Disease) :: ['ovarian tumor']
