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

Sponsor
Women's Hospital School Of Medicine Zhejiang University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06019923
Collaborator
(none)
100
48

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Other: No intervention

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 Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Study on the Dynamic Changes of Metabolic Biomarkers and Their Prognostic Relationship in Ovarian Cancer
Anticipated Study Start Date :
Sep 10, 2023
Anticipated Primary Completion Date :
Sep 10, 2026
Anticipated Study Completion Date :
Sep 10, 2027

Outcome Measures

Primary Outcome Measures

  1. Progression-Free-Survival [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
Female
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Women's Hospital School Of Medicine Zhejiang University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Women's Hospital School Of Medicine Zhejiang University
ClinicalTrials.gov Identifier:
NCT06019923
Other Study ID Numbers:
  • IRB-20230265-R
First Posted:
Aug 31, 2023
Last Update Posted:
Aug 31, 2023
Last Verified:
Aug 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 31, 2023