title: Ovarian malignancy risk stratification of the adnexal mass using a multivariate index assay.
abstract: OBJECTIVE
  To validate the effectiveness of a multivariate index assay in identifying ovarian malignancy compared to clinical assessment and CA125-II, among women undergoing surgery for an adnexal mass after enrollment by non-gynecologic oncology providers.
  
  
  METHODS
  A prospective, multi-institutional trial enrolled female patients scheduled to undergo surgery for an adnexal mass from 27 non-gynecologic oncology practices. Pre-operative serum samples and physician assessment of ovarian cancer risk were correlated with final surgical pathology.
  
  
  RESULTS
  A total of 494 subjects were evaluable for multivariate index assay, CA125-II, and clinical impression. Overall, 92 patients (18.6%) had a pelvic malignancy. Primary ovarian cancer was diagnosed in 65 patients (13.2%), with 43.1% having FIGO stage I disease. For all ovarian malignancies, the sensitivity of the multivariate index assay was 95.7% (95%CI=89.3-98.3) when combined with clinical impression. The multivariate index assay correctly predicted ovarian malignancy in 91.4% (95%CI=77.6-97.0) of cases of early-stage disease, compared to 65.7% (95%CI=49.2-79.2) for CA125-II. The multivariate index assay correctly identified 83.3% malignancies missed by clinical impression and 70.8% cases missed by CA125-II. Multivariate index assay was superior in predicting the absence of an ovarian malignancy, with a negative predictive value of 98.1% (95%CI=95.2-99.2). Both clinical impression and CA125-II were more accurate at identifying benign disease. The multivariate index assay correctly predicted benign pathology in 204 patients (50.7%, 95%CI=45.9-55.6) when combined with clinical impression.
  
  
  CONCLUSIONS
  The multivariate index assay demonstrated higher sensitivity and negative predictive value for ovarian malignancy compared to clinical impression and CA125-II in an intended-use population of non-gynecologic oncology practices.
authors.affiliation: University of California, Irvine-Medical Center, Orange, CA, USA. rbristow@uci.edu
authors.forename: Robert E
authors.initials: RE
authors.lastname: Bristow
authors.forename: Alan
authors.initials: A
authors.lastname: Smith
authors.forename: Zhen
authors.initials: Z
authors.lastname: Zhang
authors.forename: Daniel W
authors.initials: DW
authors.lastname: Chan
authors.forename: Gillian
authors.initials: G
authors.lastname: Crutcher
authors.forename: Eric T
authors.initials: ET
authors.lastname: Fung
authors.forename: Donald G
authors.initials: DG
authors.lastname: Munroe
mesh_terms: D000291:Adnexal Diseases / Q000097:blood / Q000175:diagnosis* / Q000473:pathology / Q000601:surgery; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018394:CA-125 Antigen / Q000097:blood; D005260:Female; D006801:Humans; D008565:Membrane Proteins / Q000097:blood; D008875:Middle Aged; D015999:Multivariate Analysis; D009367:Neoplasm Staging; D010051:Ovarian Neoplasms / Q000097:blood / Q000175:diagnosis* / Q000473:pathology / Q000601:surgery; D055815:Young Adult
chemical_list: D018394:CA-125 Antigen; C451759:MUC16 protein, human; D008565:Membrane Proteins