ResearchOncologyHuman epididymis protein 4 offers superior specificity in the differentiation of benign and malignant adnexal masses in premenopausal women
Section snippets
Materials and Methods
The study is a subset analysis of serum samples from a prospective, multicenter, double-blind clinical trial that enrolled women ≥18 years of age presenting with a pelvic mass who were scheduled to undergo surgery (ClinicalTrial.gov identifier NCT00315692). It was conducted at 14 clinical sites across the United States from December 2005 through February 2007. The pelvic mass had to be demonstrable on pelvic sonogram, computed tomography scan, or magnetic resonance imaging. Women with a history
Results
In all, 229 premenopausal (46%) and 265 postmenopausal (54%) women comprised the entire study protocol population. The histologic findings stratified by menopausal status are shown in Table 1. Benign masses were predominant in premenopausal women with only 8% being diagnosed with epithelial ovarian cancers (EOC) and 7% with borderline ovarian tumors (BOT). Further analysis was limited to the premenopausal group only. The median serum CA-125 value in the benign cases was 25.6 U/mL (5.1-2462.2
Comment
The serum CA-125 has been the assay of choice in the evaluation of a suspicious adnexal mass.12 However, CA-125 was proven inferior to gray-scale and Doppler ultrasound for the discrimination of benign and malignant pelvic masses in women with a persistent adnexal mass.14 The most common benign gynecologic conditions causing false-positive CA-125 results in the study by Van Calster et al14 were endometriomas (63%) and abscesses (58%), both of which were more common in premenopausal women.
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2021, International Journal of Mass SpectrometryCitation Excerpt :Dochez et al. compiled a subset of analyses to compare the diagnostic performance of CA125, HE4, and CA125 + HE4. Benchmarks showed sensitivity ranging from 58% to 97 % and specificity ranging from 53% to 98 %; high sensitivity was often accompanied by low specificity or vice versa [9] [–] [26]. OVA1® (Vermillion Inc), an FDA approved multiplexed index assay using CA125, transferrin, beta-2-microglobulin, transthyretin, and apolipoprotein A1 biomarkers, was developed as a new screening tool to be used in conjunction with physician assessment.
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Z.V. is an employee of Fujirebio Diagnostics, Inc. C.M. and R.C.K. are paid consultants for Fujirebio Diagnostics, Inc.
This study was supported by Fujirebio Diagnostics Inc, Malvern, PA.
Cite this article as: Holcomb K, Vucetic Z, Miller MC, et al. Human epididymis protein 4 offers superior specificity in the differentiation of benign and malignant adnexal masses in premenopausal women. Am J Obstet Gynecol 2011;205:358.e1-6.