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

Completed

• Conditions: Adnexal Mass; Epithelial Ovarian Cancer

• Registration Number: NCT06366997
• Lead Sponsor: Chongqing University Cancer Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-09
• Primary Completion: 2023-04-18
• Study Completion: 2023-05-05
• Study First Submitted: 2024-03-13
• Status Verified: 2024-04
• Study First Submitted QC: 2024-04-14
• Last Update Submitted: 2024-04-14
• Study First Posted: 2024-04-16
• Last Update Posted: 2024-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1352

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

No.181, Hanyulu Road, Shapingba District; 🇨🇳 Chongqing, Chongqing, China