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

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.

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Key information

Conditions

Epithelial Ovarian Cancer Adnexal Diseases Adnexal Mass Carcinoma Carcinoma, Ovarian Epithelial Disease Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Ovarian Diseases Ovarian Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

No.181, Hanyulu Road, Shapingba District

Chongqing, Chongqing Municipality, 400030, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

the Performance of Discrimination of Benign Disease and Malignant tumors by the OCS Value.

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Chongqing University Cancer Hospital

Other

Collaborators

3D Medicines Corporation
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
The First Affiliated Hospital of Zhengzhou University
Zhejiang Cancer Hospital

Registry information

Official study title

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

Important dates

Study start: 2019
Primary completion: 2023
Study completion: 2023
First posted: Apr 16, 2024
Registry last updated: Apr 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed