Study on the Dynamic Changes of Metabolic Biomarkers and Their Prognostic Relationship in Ovarian Cancer

July 14, 2025 updated by: Women's Hospital School Of Medicine Zhejiang University
Ovarian cancer is a highly lethal gynecological malignancy, often diagnosed at an advanced stage, with high rates of recurrence within 1-2 years after frontline treatment. Current guidelines recommend monitoring tumor markers CA125 and HE4 for disease progression, but these markers may not detect recurrence or disease progression when their levels are below the detection limit. Therefore, there is a need to identify new prognostic biomarkers and monitor their dynamic changes for effective risk stratification and personalized treatment in patients with ovarian cancer

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Ovarian Cancer is the deadliest gynecological malignancy, with over 70% of patients being diagnosed at advanced stages, and more than 70% experiencing recurrence within 1-2 years after frontline treatment. The recommended tumor biomarkers for monitoring ovarian cancer progression, CA125 and HE4, still pose the risk of recurrence and disease progression when their levels are below the detection limit. Therefore, it is of paramount importance to search for new prognostic monitoring biomarkers for ovarian cancer in order to stratify the prognosis and implement personalized treatment, ultimately improving patient outcomes. Previous research and literature have indicated that metabolic biomarkers can directly reflect the biochemical changes, physiological status, and disease progression in cancer patients. In comparison to studying the relationship between metabolite expression levels at a single time point and disease prognosis, the dynamic changes in metabolite trajectories with multiple time points can better reflect the dynamic patterns of disease progression throughout the entire cancer cycle, providing more prognostic information for patients with ovarian cancer.

Study Type

Observational

Enrollment (Estimated)

100

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
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • Recruiting
        • Women's Hospital School of Medicine Zhejiang University
        • Contact:

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Women who were diagnosed as high-grade serous ovarian cancer

Description

Inclusion Criteria:

  • Age between 18 and 75 years;
  • Pathological diagnosis of high-grade serous ovarian cancer;
  • Newly diagnosed ovarian cancer case without prior neoadjuvant therapy.

Exclusion Criteria:

  • Non-primary (recurrent) patients;
  • Ovarian cancer patients who have not undergone surgical treatment;
  • Patients with a history of other malignancies.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free-Survival
Time Frame: 36 months
the length of time after surgical treatment for ovarian cancer that a patient lives without any signs or symptoms of the disease getting worse
36 months

Collaborators and Investigators

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

Sponsor

Women's Hospital School Of Medicine Zhejiang University

Investigators

  • Principal Investigator: Hongyu Xie, phD, Women's Hospital School of Medicine Zhejiang University

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 26, 2023

Primary Completion (Estimated)

September 10, 2026

Study Completion (Estimated)

September 10, 2027

Study Registration Dates

First Submitted

August 24, 2023

First Submitted That Met QC Criteria

August 24, 2023

First Posted (Actual)

August 31, 2023

Study Record Updates

Last Update Posted (Actual)

July 17, 2025

Last Update Submitted That Met QC Criteria

July 14, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-20230265-R

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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