title: Evaluation of the diagnostic accuracy of the risk of ovarian malignancy algorithm in women with a pelvic mass.
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%.
  
  
  CONCLUSIONS
  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.
  
  
  METHODS
  II.
authors.affiliation: From the Department of Obstetrics and Gynecology and the Center for Biomarkers and Emerging Technologies, Program in Women's Oncology, Women and Infants' Hospital, Brown University, Providence, Rhode Island; the Section of Gynecology Oncology, Department of Obstetrics and Gynecology, Oklahoma University Health Science Center, Oklahoma City, Oklahoma; Zimmer Cancer Center, New Hanover Regional Medical Center, Wilmington, North Carolina; Jackson Clinic, Jackson, Tennessee; and the Cancer Center, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.
authors.forename: Richard G
authors.initials: RG
authors.lastname: Moore
authors.forename: M Craig
authors.initials: MC
authors.lastname: Miller
authors.forename: Paul
authors.initials: P
authors.lastname: Disilvestro
authors.forename: Lisa M
authors.initials: LM
authors.lastname: Landrum
authors.forename: Walter
authors.initials: W
authors.lastname: Gajewski
authors.forename: John J
authors.initials: JJ
authors.lastname: Ball
authors.forename: Steven J
authors.initials: SJ
authors.lastname: Skates
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000465:Algorithms; D014408:Biomarkers, Tumor / Q000097:blood; D018394:CA-125 Antigen / Q000097:blood; D004311:Double-Blind Method; D030501:Epididymal Secretory Proteins / Q000032:analysis; D005260:Female; D006801:Humans; D008875:Middle Aged; D010051:Ovarian Neoplasms / Q000175:diagnosis*; D011237:Predictive Value of Tests; D018570:Risk Assessment; D012680:Sensitivity and Specificity; D055815:Young Adult; D023083:beta-Defensins
chemical_list: D014408:Biomarkers, Tumor; D018394:CA-125 Antigen; C426184:DEFB126 protein, human; D030501:Epididymal Secretory Proteins; D023083:beta-Defensins