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Trial Title:
Study on the Dynamic Changes of Metabolic Biomarkers and Their Prognostic Relationship in Ovarian Cancer
NCT ID:
NCT06019923
Condition:
Ovarian Cancer
Conditions: Official terms:
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
No intervention
Description:
No intervention
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
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.
Criteria for eligibility:
Study pop:
Women who were diagnosed as high-grade serous ovarian cancer
Sampling method:
Non-Probability Sample
Criteria:
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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
75 Years
Locations:
Facility:
Name:
Women's Hospital School of Medicine Zhejiang University
Address:
City:
Hangzhou
Zip:
310000
Country:
China
Status:
Recruiting
Contact:
Last name:
Hongyu Xie, PhD
Email:
xiehongyu@zju.edu.cn
Start date:
October 26, 2023
Completion date:
September 10, 2027
Lead sponsor:
Agency:
Women's Hospital School Of Medicine Zhejiang University
Agency class:
Other
Source:
Women's Hospital School Of Medicine Zhejiang University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06019923
