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

December 26, 2023 updated by: Rutie Yin, West China Second University Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

35

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610016
        • Recruiting
        • west china second University， SICHUAN University, China
        • Contact:
        • Principal Investigator:
          • Rui LI, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

This study intends to include 35 patients with low CA125 level ovarian cancer at first diagnosis or recurrence between the ages of 18-75 years old.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The prognostic value of MRD
Time Frame: 12 months
The sensitivity of MRD in CA125 low level ovarian patients.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progress Free Survival
Time Frame: 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
From date of the beginning of therapy to disease metastasis or recurrence due to any cause,assessed up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

West China Second University Hospital

Investigators

  • Principal Investigator: Mengpei Zhang, West China Second University Hospital
  • Principal Investigator: Rui Li, West China Second University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2023

Primary Completion (Estimated)

December 30, 2025

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

November 25, 2023

First Submitted That Met QC Criteria

December 26, 2023

First Posted (Estimated)

December 27, 2023

Study Record Updates

Last Update Posted (Estimated)

December 27, 2023

Last Update Submitted That Met QC Criteria

December 26, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WCSUH20231108

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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