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. CONCLUSION: 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.
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. CONCLUSION: 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: Richard G Moore; Alexandra Blackman; M Craig Miller; Katina Robison; Paul A DiSilvestro; Elizabeth E Eklund; Robert Strongin; Geralyn Messerlian Journal: Gynecol Oncol Date: 2019-04-13 Impact factor: 5.482
Authors: Elizabeth Lokich; Marguerite Palisoul; Nicole Romano; M Craig Miller; Katina Robison; Ashley Stuckey; Paul DiSilvestro; Cara Mathews; C O Granai; Geralyn Lambert-Messerlian; Richard G Moore Journal: Gynecol Oncol Date: 2015-09-11 Impact factor: 5.482
Authors: Matthew F Buas; Haiwei Gu; Danijel Djukovic; Jiangjiang Zhu; Charles W Drescher; Nicole Urban; Daniel Raftery; Christopher I Li Journal: Gynecol Oncol Date: 2015-10-30 Impact factor: 5.482
Authors: Jin Song; Lori J Sokoll; Jered J Pasay; Abigail L Rubin; Hanying Li; Dylan M Bach; Daniel W Chan; Zhen Zhang Journal: Cancer Epidemiol Biomarkers Prev Date: 2018-10-17 Impact factor: 4.254