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NCT Number: NCT06019923

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

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

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Key information

Age range

18 year–75 year

Sex eligibility

Female

Study type

Observational

Primary location

Women's Hospital School of Medicine Zhejiang University

Hangzhou, Zhejiang, 310000, China

Location status: Recruiting

Location contact

Hongyu Xie, PhD

CONTACT

[email protected]

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Hongyu Xie, phD

CONTACT

[email protected]

+86-15244773429

Sponsors and collaborators

Lead sponsor

Women's Hospital School Of Medicine Zhejiang University

Other

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Aug 31, 2023
Registry last updated
Jul 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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