The Utility of Circulating Tumor DNA in Monitoring the Response to Pegylated Liposomal Doxorubicin in Platinum-resistant Ovarian Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 主要终点
- the consistency of circulating tumor DNA with CT scan
研究概览
简要总结
This observational study is conducted to assess the utility of circulating tumor DNA in monitoring the response to pegylated liposomal doxorubicin in platinum-resistant ovarian cancer，and evaluate the consistency of circulating tumor DNA with imaging and CA125 in platinum-resistant ovarian cancer.
详细描述
The goal of this study is to assess the utility of circulating tumor DNA in monitoring the response to pegylated liposomal doxorubicin in platinum-resistant ovarian cancer.This is a single-arm, single-center prospective clinical study.
After enrollment, patients will receive standard treatment (pegylated liposomal doxorubicin)and follow-up strategy. Peripheral blood samples will be collected from all patients before treatment and 3 weeks after the first cycle of treatment，If necessary, Peripheral blood samples also be collected after 2 cycles of treatment.Peripheral blood ctDNA will be tested for genetic variation based on next-generation sequencing (NGS).
Finally, this study will to evaluate the consistency of circulating tumor DNA with imaging and CA125 in platinum-resistant ovarian cancer.
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
- •Female, over 18 years of age;
- •Patients with histopathological diagnosis of high-grade serous epithelial ovarian cancer;
- •pathological report:phenotype of p53 mutation；or previous genetic tests of tumor tissue indicated TP53 gene mutations;
- •Expected survival time ≥3 months;
- •The subjects were able to understand the study process and voluntarily joined the study.
排除标准
- •Pregnant and lactating patients;
- •Patients with severe or uncontrolled infections;
- •Patients who are allergic or intolerant to the investigational drug;
- •Patients who are enrolled in or within a month of another clinical trial.
研究组 & 干预措施
treatment group
After enrollment, patients will receive standard treatment (pegylated liposomal doxorubicin) and follow-up strategy. Peripheral blood samples will be collected from all patients before treatment and 3 weeks after the first cycle of treatment，If necessary, Peripheral blood samples also be collected after 2 cycles of treatment.
干预措施: pegylated liposomal doxorubicin (Drug)
结局指标
主要结局
the consistency of circulating tumor DNA with CT scan
时间窗: at the beginning of Cycle 1 and 3 weeks after Cycle 1. If necessary, also including 3 weeks after Cycle 2（each cycle is 28 days）
measuring the mutations of TP53，reporting the changes from baseline to 3 weeks after the first cycle, contrasting with CT scan changes，calculating Kappa value，and conducting a intrarater reliability
次要结局
未报告次要终点
研究者
Xiaohua Wu
Director,Clinical Professor
Fudan University