Objectives. 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.
Bibliographical noteFunding Information:
Richard G. Moore has received research funding from Fujirebio Diagnostics, Inc. and Abbott Diagnostics, Inc. Doug M. Hawkin is a Statistical Consultant for Fujirebio Diagnostics, Inc. M. Craig Miller is a Database design consultant for Fujirebio Diagnostics, Inc. W. Jeffrey Allard is a consultant for Fujirebio Diagnostics, Inc. Lisa M. Landrum, Walter Gajewski, John J. Ball and Steven J. Skates have no conflicts to report.
© 2014 Elsevier Inc. All rights reserved.
- Ovarian cancer
- Pelvic mass
- Risk assessment