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

NCT06366997 | Completed

• 1 other identifier: CQGOG0207
• Study Type: observational
• Target: 1,352
• Locations: 1 country
• Sites: 1

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.

Conditions

Epithelial Ovarian Cancer; Adnexal Mass

Keywords

early diagnosis; ovarian cancer; OCS test

Outcome Measures

Primary Outcomes (1)

• 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.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adnexal masses (i.e., lumps near the uterus or in or around the ovaries, fallopian tubes, or surrounding connecting tissues) are common and are often detected by primary care providers and gynecologists. Adnexal masses are seen in up to 35% of premenopausal women and 17% of postmenopausal women and can occur throughout a woman's life. Although the majority of these masses are benign, they must be evaluated to rule out the possibility of malignant ovarian cancer. Ovarian cancer is one of the most aggressive gynecologic tumors worldwide, with over 31,4000 new cases diagnosed and 21,3000 deaths each year1,2. Ovarian cancer is the most lethal gynecologic malignancy with an overall 5-year survival rate of 45%.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chongqing University Cancer Hospital: lead
• Zhejiang Cancer Hospital: collaborator
• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: collaborator
• The First Affiliated Hospital of Zhengzhou University: collaborator
• 3D Medicines Corporation: collaborator

Study Sites (1)

No.181, Hanyulu Road, Shapingba District

Chongqing, Chongqing Municipality, 400030, China

Location

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial; Disease; Ovarian Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Qi Zhou

  Chongqing University Cancer Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2024
• First Posted: April 16, 2024
• Study Start: October 9, 2019
• Primary Completion: April 18, 2023
• Study Completion: May 5, 2023
• Last Updated: April 16, 2024

Record last verified: 2024-04

Locations

CN (1)