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

Epithelial Ovarian Cancer Clinical Trial

Official title:

Multicenter Clinical Research for Diagnosis of Epithelial Ovarian Cancer Using OCS Test

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06366997
• Other study ID #: CQGOG0207
• Status: Completed
• Start date: October 9, 2019
• Est. completion date: May 5, 2023

Study information

• Verified date: April 2024
• Source: Chongqing University Cancer Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1352
• Est. completion date: May 5, 2023
• Est. primary completion date: April 18, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adnexal Mass
• Carcinoma, Ovarian Epithelial
• Epithelial Ovarian Cancer
• Ovarian Neoplasms

Locations

Country	Name	City	State
China	No.181, Hanyulu Road, Shapingba District	Chongqing	Chongqing

Sponsors (5)

Lead Sponsor	Collaborator
Chongqing University Cancer Hospital	3D Medicines Corporation, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, The First Affiliated Hospital of Zhengzhou University, Zhejiang Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Data analysis would be completed in three months after all data were collected.