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

NCT ID: NCT06366997

Last Updated: 2024-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1352 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-10-09

Study Completion Date

2023-05-05

Brief Summary

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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

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Conditions

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Epithelial Ovarian Cancer Adnexal Mass

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Zhejiang Cancer Hospital

OTHER

Sponsor Role collaborator

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Zhengzhou University

OTHER

Sponsor Role collaborator

3D Medicines Corporation

UNKNOWN

Sponsor Role collaborator

Chongqing University Cancer Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Qi Zhou

Role: PRINCIPAL_INVESTIGATOR

Chongqing University Cancer Hospital

Locations

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No.181, Hanyulu Road, Shapingba District

Chongqing, Chongqing Municipality, China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 39793443 (View on PubMed)

Other Identifiers

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CQGOG0207

Identifier Type: -

Identifier Source: org_study_id

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