title: Phase II biomarker trial of a multimarker diagnostic for ovarian cancer.
abstract: OBJECTIVE
  The primary hypothesis to be tested in this study was that the diagnostic performance (as assessed by the area under the receiver operator characteristic curve, AUC) of a multianalyte panel to correctly identify women with ovarian cancer was significantly greater than that for CA-125 alone.
  
  
  METHODS
  A retrospective, case-control study (phase II biomarker trial) was conducted that involved 362 plasma samples obtained from women with ovarian cancer (n = 150) and healthy controls (n = 212). A multivariate classification model was developed that incorporated five biomarkers of ovarian cancer, CA-125; C-reactive protein (CRP); serum amyloid A (SAA); interleukin 6 (IL-6); and interleukin 8 (IL-8) from a modelling cohort (n = 179). The performance of the model was evaluated using an independent validation cohort (n = 183) and compared with of CA-125 alone.
  
  
  RESULTS
  The AUC for the biomarker panel was significantly greater than the AUC for CA-125 alone for a validation cohort (p < 0.01) and an early stage disease cohort (i.e. Stages I and II; p < 0.01). At a threshold of 0.3, the sensitivity and specificity of the multianalyte panel were 94.1 and 91.3%, respectively, for the validation cohort and 92.3 and 91.3%, respectively for an early stage disease cohort.
  
  
  CONCLUSIONS
  The use of a panel of plasma biomarkers for the identification of women with ovarian cancer delivers a significant increase in diagnostic performance when compared to the performance of CA-125 alone.
authors.affiliation: HealthLinx Limited, 576 Swan Street, Richmond, VIC 3121, Australia. t.edgell@healthlinx.com.au
authors.forename: Tracey
authors.initials: T
authors.lastname: Edgell
authors.forename: G
authors.initials: G
authors.lastname: Martin-Roussety
authors.forename: G
authors.initials: G
authors.lastname: Barker
authors.forename: D J
authors.initials: DJ
authors.lastname: Autelitano
authors.forename: D
authors.initials: D
authors.lastname: Allen
authors.forename: P
authors.initials: P
authors.lastname: Grant
authors.forename: G E
authors.initials: GE
authors.lastname: Rice
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D014408:Biomarkers, Tumor / Q000097:blood; D002097:C-Reactive Protein / Q000032:analysis; D018394:CA-125 Antigen / Q000097:blood*; D016022:Case-Control Studies; D017322:Clinical Trials, Phase II as Topic; D015331:Cohort Studies; D005260:Female; D006801:Humans; D015850:Interleukin-6 / Q000097:blood; D016209:Interleukin-8 / Q000097:blood; D008875:Middle Aged; D015999:Multivariate Analysis; D010051:Ovarian Neoplasms / Q000097:blood* / Q000175:diagnosis*; D012189:Retrospective Studies; D012680:Sensitivity and Specificity; D000685:Serum Amyloid A Protein / Q000032:analysis; D055815:Young Adult
chemical_list: D014408:Biomarkers, Tumor; D018394:CA-125 Antigen; D015850:Interleukin-6; D016209:Interleukin-8; D000685:Serum Amyloid A Protein; D002097:C-Reactive Protein