title: Performance of the American College of Obstetricians and Gynecologists' ovarian tumor referral guidelines with a multivariate index assay.
abstract: OBJECTIVE
  The American College of Obstetricians and Gynecologists (the College) published referral guidelines for women with a pelvic mass that incorporate CA 125. A new multivariate index assay assesses the malignant risk of ovarian tumors 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 women scheduled for surgery for an ovarian mass. Clinical criteria and blood for biomarkers were collected before surgery. A standard CA 125-II assay was used and the value applied to the multivariate index assay algorithm and the CA 125 analysis. Study results were correlated with surgical pathology.
  
  
  RESULTS
  Of the 590 women enrolled with ovarian mass on pelvic imaging, 516 were evaluable. There were 161 malignancies (45 premenopausal and 116 postmenopausal). The College referral criteria had a modest sensitivity in detecting malignancy. Replacing CA 125 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 women and early-stage disease.
  
  
  CONCLUSIONS
  Replacing CA 125 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 women and early-stage disease.
authors.affiliation: From the Department of Obstetrics and Gynecology, Division of Gynecologic Oncology, University of Kentucky Markey Cancer Center, Lexington, Kentucky; Applied Clinical Intelligence, Bala Cynwyd, Pennsylvania; and the Department of Pathology, Center for Biomarker Discovery, Johns Hopkins Medical Institutions, Baltimore, Maryland.
authors.forename: Rachel Ware
authors.initials: RW
authors.lastname: Miller
authors.forename: Alan
authors.initials: A
authors.lastname: Smith
authors.forename: Christopher P
authors.initials: CP
authors.lastname: DeSimone
authors.forename: Leigh
authors.initials: L
authors.lastname: Seamon
authors.forename: Scott
authors.initials: S
authors.lastname: Goodrich
authors.forename: Iwona
authors.initials: I
authors.lastname: Podzielinski
authors.forename: Lori
authors.initials: L
authors.lastname: Sokoll
authors.forename: John R
authors.initials: JR
authors.lastname: van Nagell
authors.forename: Zhen
authors.initials: Z
authors.lastname: Zhang
authors.forename: Frederick R
authors.initials: FR
authors.lastname: Ueland
mesh_terms: D000328:Adult; D000368:Aged; D000465:Algorithms; D014408:Biomarkers, Tumor / Q000097:blood*; D018394:CA-125 Antigen / Q000097:blood; D005260:Female; D006801:Humans; D008875:Middle Aged; D010051:Ovarian Neoplasms / Q000097:blood* / Q000175:diagnosis*; D017410:Practice Guidelines as Topic; D011237:Predictive Value of Tests; D011446:Prospective Studies; D012017:Referral and Consultation; D018570:Risk Assessment; D012680:Sensitivity and Specificity; D012720:Severity of Illness Index; D012955:Societies, Medical
chemical_list: D014408:Biomarkers, Tumor; D018394:CA-125 Antigen