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

Ovarian Cancer Clinical Trial

Official title:

A Study for Assessing the Value of Minimal Residual Disease Detection in Disease Monitoring of CA125 Non-sensitive Ovarian Cancer Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06182917
• Other study ID #: WCSUH20231108
• Status: Recruiting
• Start date: October 1, 2023
• Est. completion date: June 30, 2026

Study information

• Verified date: December 2023
• Source: West China Second University Hospital
• Contact: Rutie Yin
• Phone: 028-88570403
• Email: yrtt2013[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: June 30, 2026
• Est. primary completion date: December 30, 2025
• Gender: Female
• Age group: N/A and older

Eligibility

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;

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

Locations

Country	Name	City	State
China	west china second University, SICHUAN University, China	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
West China Second University Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The prognostic value of MRD	The sensitivity of MRD in CA125 low level ovarian patients.	12 months
Secondary	Progress Free Survival	PFS differences in patients with different MRD level	From date of the beginning of therapy to disease metastasis or recurrence due to any cause,assessed up to 24 months