%0 Journal Article
%T Performance of ROMA based on Architect CA 125 II and HE4 values in Chinese women presenting with a pelvic mass: A multicenter prospective study.
%A Shen F
%A Lu S
%A Peng Y
%A Yang F
%A Chen Y
%A Lin Y
%A Yang C
%A Wu L
%A Li H
%A Zheng Y
%J Clin Chim Acta
%V 471
%N 0
%D Aug 2017
%M 28549533
%F 6.314
%R 10.1016/j.cca.2017.05.029
%X <B>BACKGROUND: </B>We evaluated the performance of human epididymis protein 4 (HE4), cancer antigen 125(CA 125) and Risk of Ovarian Malignancy Algorithm (ROMA) in distinguishing between benign and malignant pelvic masses in Chinese women.<BR><B>METHODS: </B>From April to December 2012, women with a pelvic mass scheduled to have surgery were enrolled in a prospective, multi-center study conducted in 5 different regions in China. Preoperative serum concentrations of HE4 and CA 125 were examined and ROMA was calculated.<BR><B>RESULTS: </B>A total of 684 women with a pelvic mass were included, of which 482 were diagnosed with benign conditions and 202 were diagnosed with malignant ovarian tumors. At cutoffs of 7.4% and 25.3% for ROMA, the sensitivities and specificities were 85.6% and 81.7% for all patients, 85.7% and 81.5% for premenopausal women, and 85.6% and 83.9% for postmenopausal women, respectively. The ROC-AUC of ROMA was significantly better than that of HE4 (P=0.0003) or CA 125 (P<0.0001) for all malignant diseases (including EOC, Non-EOC, LMP, metastases and other pelvic malignancy with no involvement of the ovaries) compared with benign diseases for all patients.<BR><B>CONCLUSIONS: </B>We demonstrated the efficiency of ROMA in the distinction of ovarian cancers from benign disease in a multiple-regions Chinese population, especially in premenopausal women.