The study is designed to confirm the performance of the 3D Medicines Corporation OCS test in diagnosis of epithelial ovarian cancer in patients with adnexal mass. To this end, blood samples from female patients with adnexal mass required surgical resection from four centers are obtained and analysis in the study.
Study Type
OBSERVATIONAL
Enrollment
1,352
No.181, Hanyulu Road, Shapingba District
Chongqing, Chongqing Municipality, China
the Performance of Discrimination of Benign Disease and Malignant tumors by the OCS Value.
Evaluation of the performance of the OCS value in discriminating between benign and malignant tumors. Serum was collected before surgery. The serum OCS value was calculated with the serum level of extracellular vesicle biomarkers using a preset formula. The unit for each EV biomarker in the formula was as follows: Carbohydrate antigen 125 (CA125, U/ml), Human Epididymis Protein (HE4, pmol/L) and Complement Component 5a (5a, ng/ml). The OCS value was a numerical value witout units. The OCS value above the preset cut-off (0.506) value indicated maligant tumor, otherwise the adnexal mass was benign. The concordance between the pathological results (gold standard) and the results predicted by the OCS value was compared.
Time frame: Data analysis would be completed in three months after all data were collected.
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