A prospective investigation of tumor membrane fragments in the differentiation of benign and malignant adnexal masses prior to surgery

Abstract

5112 Background: Non-invasive methods of differentiating benign from malignant adnexal masses are urgently needed in order to spare women unnecessary surgery. Methods: We investigated whether the identification of tumor membrane fragments (TMF) in the serum can differentiate between benign and malignant adnexal masses in women prior to surgery. Informed consent was obtained and blood was taken before or at surgery and serum was extracted and stored at -700C. Relevant data was extracted from medical records. A control group was composed of women participating in an ovarian cancer screening study with no personal cancer history and with at least two consecutive normal annual ultrasound scans of the ovaries. TMF were isolated from sera and quantitated using a standard technique. Protein levels are reported in mg/ml. Statistical analysis was performed using Students t-test assuming unequal variances. Results: One hundred and eight women were included in the study with a mean age of 52 years (15–82). Eighty-six underwent surgery for an adnexal mass, 64 were benign, 22 malignant and there were 22 controls. Pathology of the cancers included ovarian cancer 18 (epithelial 15 including 5 low malignant potential, dysgerminoma 1, granulosa cell tumor 2,) and endometrial cancer 4. The FIGO stage included stage I=8, II=1, III= 6, IV=7. The mean TMF protein concentrations (mg/ml ±SD) versus control 0.669 ± 0.259 were benign mass 0.94 ± 0.67 (p=0.003) and malignant mass 1.19 ±0.904 (p=0.007). There was no significant difference of the protein levels between benign and malignant masses (p= ) but there was a trend which was greater when LMP ovarian tumors were excluded. There was no significant difference of TMF protein levels between early and more advanced stage of ovarian cancer, stage I= 1.292 ± 1.198, stage II-IV=1.14 ± 0.911 (p= 0.44). Conclusions: Tumor membrane fragments can differentiate women who are normal from those with an adnexal mass. Greater accuracy in differentiating benign from malignant masses may be possible with the detection of biomarkers associated with the membrane fragments. No significant financial relationships to disclose.