Diagnosis of Epithelial Ovarian Cancer Using Ovarian Cancer Score (OCS) Test

Primary outcomes

• the Performance of Discrimination of Benign Disease and Malignant tumors by the OCS Value. [Data analysis would be completed in three months after all data were collected.]: 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.

Sex: Female, ages: 18 Years to any, accepts healthy volunteers

Inclusion Criteria:

* a) ≥ 18 years of age;
* b) Patients with adnexal masses;
* c) Sign the informed consent form;
* d) Adnexal mass that requires excision;

Exclusion Criteria:

* a) history of chemoradiotherapy;
* b) history of malignancy;
* c) pregnancy;
* d) Adnexal mass not require surgical excision;
* e) The adnexal mass has been diagnosed as malignant before surgery, and the number of cases enrolled in a single institution exceeds 50;
* f) Blood CA125 value greater than 1000 U/ml at initial treatment.

• Results publication: Wang H, Zhu J, Zou D, Rao Q, Han L, Lu H, Wang J, Liu L, Ma L, Sun L, Yi L, Feng W, Zhang Y, Du Y, Yang M, Feng Y, Zhang D, Lin Z, Zhou Q. Multicenter study of ovarian cancer score for diagnosing ovarian cancer. Gynecol Oncol. 2025 Feb;193:58-64. doi: 10.1016/j.ygyno.2024.12.017. Epub 2025 Jan 9. PMID 39793443

• Qi Zhou, Principal investigator, Chongqing University Cancer Hospital