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

Recruiting

• Conditions: Ovarian Cancer

• Registration Number: NCT06182917
• Lead Sponsor: West China Second University Hospital

Brief Summary

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

Not available

Study Timeline

• Study Start: 2023-10-01
• Study First Submitted: 2023-11-25
• Status Verified: 2023-12
• Study First Submitted QC: 2023-12-26
• Last Update Submitted: 2023-12-26
• Study First Posted: 2023-12-27
• Last Update Posted: 2023-12-27
• Primary Completion: 2025-12-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 35

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;

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The prognostic value of MRD	12 months	The sensitivity of MRD in CA125 low level ovarian patients.

Secondary Outcome Measures

Name	Time	Method
Progress Free Survival	From date of the beginning of therapy to disease metastasis or recurrence due to any cause,assessed up to 24 months	PFS differences in patients with different MRD level

Trial Locations

Locations (1)

west china second University， SICHUAN University, China; 🇨🇳 Chengdu, Sichuan, China