title: Combining clinical assessment and the Risk of Ovarian Malignancy Algorithm for the prediction of ovarian cancer.
abstract: OBJECTIVE
  ACOG guidelines for the evaluation of women with a pelvic mass employ a combination of physical exam, imaging, and CA125 to guide physicians in the triage of women to gynecologic oncologists. We studied the use of ROMA with clinical assessment for cancer risk assessment in women with a pelvic mass.
  
  
  METHODS
  This was a prospective, multicenter trial evaluating women with a pelvic mass who had an initial clinical risk assessment (ICRA) performed by a generalist. ROMA scores were calculated and sensitivity, specificity, PPV and NPV were determined for ICRA and ICRA+ROMA.
  
  
  RESULTS
  A total of 461 women were entered into the study. There were 375 benign tumors, 48 EOC, 18 LMP tumors and 20 non-ovarian malignancies. For detection of ovarian cancer alone, ICRA had a sensitivity of 85.4%, a specificity of 84.3%, and a NPV of 97.8%. Adding ROMA to ICRA produced a significant improvement of 8.4% in sensitivity, achieving a sensitivity of 93.8% with a specificity of 67.2% and a NPV of 98.8%. Examination of all malignancies (ovarian & non-ovarian) provided a sensitivity of 89.7% for ROMA+ICRA in comparison to 77.9% for ICRA alone, a significant increase in sensitivity of 11.8%. The NPV also significantly increased from 95.5% to 97.3%. Overall, ROMA detected 13 additional malignancies missed by ICRA.
  
  
  CONCLUSIONS
  Adjunctive use of ROMA with clinical assessment improves the stratification of women with a pelvic mass into low and high risk groups for ovarian cancer. The combination is particularly effective in ruling out malignant disease.
authors.affiliation: Program in Women's Oncology, Department of Obstetrics and Gynecology, Women and Infants Hospital, Alpert Medical School, Brown University, Providence, RI, USA. Electronic address: rmoore@wihri.org.
authors.forename: Richard G
authors.initials: RG
authors.lastname: Moore
authors.affiliation: School of Statistics, University of Minnesota, Minneapolis, MN, USA.
authors.forename: Douglas M
authors.initials: DM
authors.lastname: Hawkins
authors.affiliation: Program in Women's Oncology, Department of Obstetrics and Gynecology, Women and Infants Hospital, Alpert Medical School, Brown University, Providence, RI, USA.
authors.forename: M Craig
authors.initials: MC
authors.lastname: Miller
authors.affiliation: Section of Gynecology Oncology, Department of Obstetrics and Gynecology, Oklahoma University Health Science Center, Oklahoma City, OK, USA.
authors.forename: Lisa M
authors.initials: LM
authors.lastname: Landrum
authors.affiliation: Zimmer Cancer Center, New Hanover Regional Medical Center, Wilmington, NC, USA.
authors.forename: Walter
authors.initials: W
authors.lastname: Gajewski
authors.affiliation: Jackson Clinic, Jackson, TN, USA.
authors.forename: John J
authors.initials: JJ
authors.lastname: Ball
authors.affiliation: Medivice Consulting, New Durham, NH, USA.
authors.forename: W Jeffery
authors.initials: WJ
authors.lastname: Allard
authors.affiliation: Cancer Center, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.
authors.forename: Steven J
authors.initials: SJ
authors.lastname: Skates
mesh_terms: D000465:Algorithms; D014408:Biomarkers, Tumor / Q000378:metabolism; D005260:Female; D006801:Humans; D008954:Models, Biological; D009367:Neoplasm Staging; D010051:Ovarian Neoplasms / Q000175:diagnosis* / Q000378:metabolism / Q000473:pathology; D011446:Prospective Studies; D018570:Risk Assessment
chemical_list: D014408:Biomarkers, Tumor
keywords: Ovarian cancer; Pelvic mass; ROMA; Risk assessment