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Prognostic Value of MRD Detection in CA125 Non-sensitive Ovarian Cancer Patients

NCT ID: NCT06182917

Last Updated: 2023-12-27

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

RECRUITING

Total Enrollment

35 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-01

Study Completion Date

2026-06-30

Brief Summary

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Ovarian cancer ranks third in the incidence of gynecologic malignancies, while mortality ranks first. The tumor marker CA125 is the most concerned tumor marker in the clinical monitoring prognosis of ovarian cancer, and an elevated CA125 indicates a later stage and a worse prognosis. However about 20% of patients with ovarian cancer have low CA125 expression. Therefore, CA125 is not sensitive to some ovarian cancers with a high risk of recurrence. How to improve the diagnostic performance of these CA125-insensitive patients is a difficult problem in current research. Minimal residual disease (MRD) refers to the residual tumor components in the body of tumor patients after achieving complete remission through treatment. MRD detection is mainly achieved by liquid biopsy, and residual tumor components can be detected by circulating tumor DNA (ctDNA). This study aims to explore the value of MRD (ctDNA) in the risk assessment of CA125 non sensitive ovarian cancer populations by combining ctDNA with traditional imaging and serological tumor markers.

Detailed Description

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Conditions

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Ovarian Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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ctDNA alternation during the treatment of Ovarian cancer

Tumor samples of included patients were detected by WES, and 16 major clonal mutation sites were screened for the personalized monitoring panel. All patients received blood ctDNA detection to monitor the major clonal alternation after 3 cycels treatment or 3 months after therapy, at the same time, the detection of serum tumor markers (CA125) and imaging examination were carried out, in order to evaluate the MRD detection efficiency.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Age 18-75;
* Pathologically confirmed ovarian cancer;
* CA125 ≤200U/ml at first diagnosis or recurrence;
* Physical condition score PS ≤ 2 points;
* Enough tumor samples for WES detection;
* Patients and their families can understand and are willing to participate in this study and provide written informed consent.

Exclusion Criteria

* Patients unable to provide sufficient tissue / blood samples for research detection;
* Pregnant or lactating women;
* Other diseases considered by the research doctor to affect the prognosis and survival;
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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West China Second University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Rutie Yin

West China Second University Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mengpei Zhang

Role: PRINCIPAL_INVESTIGATOR

West China Second University Hospital

Rui Li

Role: PRINCIPAL_INVESTIGATOR

West China Second University Hospital

Locations

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west china second University， SICHUAN University, China

Chengdu, Sichuan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Rutie Yin

Role: CONTACT

Phone: 028-88570403

Email: [email protected]

Facility Contacts

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rutie YIN, M.D.

Role: primary

Other Identifiers

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WCSUH20231108

Identifier Type: -

Identifier Source: org_study_id