Adnexal Mass, Epithelial Ovarian Cancer
Conditions
Keywords
early diagnosis, ovarian cancer, OCS test
Brief summary
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.
Interventions
None listed
Sponsors
Zhejiang Cancer Hospital
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
The First Affiliated Hospital of Zhengzhou University
3D Medicines Corporation
Chongqing University Cancer Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Outcome results
None listed