Skip to main content
Clinical Trials/NCT06182917
NCT06182917
Recruiting
Not Applicable

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

West China Second University Hospital1 site in 1 country35 target enrollmentOctober 1, 2023
ConditionsOvarian Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Ovarian Cancer
Sponsor
West China Second University Hospital
Enrollment
35
Locations
1
Primary Endpoint
The prognostic value of MRD
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2023
End Date
June 30, 2026
Last Updated
2 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
West China Second University Hospital
Responsible Party
Principal Investigator
Principal Investigator

Rutie Yin

West China Second University Hospital

West China Second University Hospital

Eligibility Criteria

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;

Outcomes

Primary Outcomes

The prognostic value of MRD

Time Frame: 12 months

The sensitivity of MRD in CA125 low level ovarian patients.

Secondary Outcomes

  • Progress Free Survival(From date of the beginning of therapy to disease metastasis or recurrence due to any cause,assessed up to 24 months)

Study Sites (1)

Loading locations...

Similar Trials