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

NCT06019923 | Recruiting

• 1 other identifier: IRB-20230265-R
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-Free-Survival

  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

Interventions

No intervention OTHER

No intervention

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women who were diagnosed as high-grade serous ovarian cancer

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Women's Hospital School Of Medicine Zhejiang University: lead

Study Sites (1)

Women's Hospital School of Medicine Zhejiang University

Hangzhou, Zhejiang, 310000, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

The collected plasma samples are used for plasma metabolomics analysis.

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Hongyu Xie, phD

  Women's Hospital School Of Medicine Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hongyu Xie, phD

CONTACT

+86-15244773429; xiehongyu@zju.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2023
• First Posted: August 31, 2023
• Study Start: October 26, 2023
• Primary Completion (Estimated): September 10, 2026
• Study Completion (Estimated): September 10, 2027
• Last Updated: July 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)