Circulating Tumor DNA as a Novel Molecular Marker of Treatment Efficacy to Guide Targeted Maintenance Therapy for Patients With High Grade Serous Ovarian Cancer
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
This study is a prospective observational clinical trial. Patients who were diagnosed and treated for the first time were enrolled and their surgical pathology was confirmed to be high-grade serous ovarian cancer. At the same time, these patients will receive first-line maintenance treatment with PARP inhibitors after traditional chemotherapy. During the trial period, patients' plasma will be collected before surgery, after chemotherapy, during targeted maintenance therapy, and during disease progression, and ctDNA-specific genomes will be detected, and clinical data will be collected over the same period. It is expected that specific ctDNA can be used to predict the efficacy of PARP inhibitors in patients with ovarian cancer, and to detect the recurrence of the disease early.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Ovarian cancer first diagnosed and treated;
- •Pathologically confirmed as epithelial ovarian cancer/fallopian tube cancer/primary peritoneal cancer;
- •The stage of the disease is II-IV, and surgery will be performed after evaluation;
- •Age ≥ 18 years old;
- •Subjects and their families fully understand the research plan and sign an informed consent form.
排除标准
- •Pathologically confirmed as non-epithelial ovarian cancer;
- •Surgical treatment cannot be performed after evaluation;
- •Malignant tumors found in other parts of the study were found within five years before enrollment or at the time of enrollment;
- •Patients who do not agree to use clinical first-line targeted drugs;
- •Severe mental illness;
- •Severe cardiovascular disease, uncontrollable infection, or other uncontrollable comorbid diseases.
研究组 & 干预措施
patients using olaparib only
patients using olaparib combined with bevacizumab
结局指标
主要结局
Progression-free survival
时间窗: about 36 months after using PARP inhibitors
To determine the different prognosis of patients after using the PARP inhibitor for first-line maintenance treatment, at the same time, the plasma will be collected and tested for ctDNA before using the PARP inhibitor, during use and when the disease is progressing.
次要结局
- Overall survival(about over 5 years after using PARP inhibitors)
- Objective response rate(36 months after using PARP inhibitors)