跳至主要内容
临床试验/NCT06019923
NCT06019923招募中不适用

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

Women's Hospital School Of Medicine Zhejiang University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年10月26日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
1
主要终点
Progression-Free-Survival

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Progression-Free-Survival

时间窗: 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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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