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

Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06019923
• Other study ID #: IRB-20230265-R
• Status: Recruiting
• Start date: October 26, 2023
• Est. completion date: September 10, 2027

Study information

• Verified date: November 2023
• Source: Women's Hospital School Of Medicine Zhejiang University
• Contact: Hongyu Xie, phD
• Phone: +86-15244773429
• Email: xiehongyu[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 10, 2027
• Est. primary completion date: September 10, 2026
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
China	Women's Hospital School of Medicine Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Women's Hospital School Of Medicine Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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