Dynamic Monitoring of ctDNA Predicts Recurrence of Advanced Ovarian Cancer After Primary Treatments
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- 2 years DFS rate
研究概览
简要总结
Patients who receive satisfactory PDS, currently the change in CA125 during chemotherapy can only be used to evaluate the effectiveness of chemotherapy. This study plans to use ctDNA dynamic monitoring to detect minimal residual lesions during treatment, to demonstrate the application value of ctDNA dynamic monitoring in predicting the recurrence of ovarian cancer after PDS/IDS surgery.
详细描述
This study plans to include ovarian cancer patients who have undergone PDS/IDS surgery. By analyzing the surgical tissue samples of ovarian cancer patients, we aim to identify risk factors related to the prognosis and recurrence of ovarian cancer. By monitoring the ctDNA status after PDS surgery, we analyze the role of ctDNA-MRD in predicting postoperative recurrence of ovarian cancer. By monitoring the MRD status at the end of the 3rd cycle of adjuvant chemotherapy and at the end of adjuvant treatment, we analyze the predictive role of serial cDNA-MRD for the efficacy of adjuvant treatment, providing a basis for determining the number of cycles of adjuvant treatment after PDS.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
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
- •≥ 18 years old.
- •Patients diagnosed with stage IIIC-IVA ovarian cancer through pathological examination.
- •The participant has read and fully understands the patient information, and has signed the informed consent form.
- •The patient is willing to undergo primary debulking surgery (PDS) or interval debulking surgery（IDS）. -
排除标准
- •Other tumors have been detected within the last 5 years.
- •Organ transplant recipients or those who previously had non-autologous (allogeneic) bone marrow or stem cell transplants.
- •Patients was deemed unsuitable to participate in this study by other researchers.
- •Patients who have previously received neoadjuvant chemotherapy or targeted therapy.
结局指标
主要结局
2 years DFS rate
时间窗: 2 years
The recurrence rate of patients at two years after surgery
次要结局
- DFS(2 years)
研究者
Jing Li
Professor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University