Assessment of the Minimal Residual Disease in Ovarian Cancer From Circulating Tumor DNA and Immune Repertoire
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 104
- 试验地点
- 6
- 主要终点
- The ctDNA characteristics in patients with ovarian cancer , the correlation between the clonal status of mutations and therapy response and whether ctDNA detection can be used to predict the risk of ovarian cancer recurrence.
研究概览
简要总结
To analyze the proportion of hereditary tumors in ovarian cancer patients in China, as well as the spectrum of variations; the ctDNA characteristics in patients with ovarian cancer; the correlation between the clonal status of mutations and therapy response; whether ctDNA detection can be used to predict the risk of ovarian cancer recurrence; and the characteristics of immune repertoire before and after treatment in patients with ovarian cancer.
详细描述
100 OC cases with available matched tumor DNA and plasma will be collected. All patients will be treated according to clinical guidelines, and receive circulating tumor DNA (ctDNA) liquid biopsy at the time of diagnosis, at mid treatment, at the end of treatment and during follow-up. The study will be ended when the patients have progressive disease (PD) or reach the longest follow-up time (2 years).
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 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients who have not received treatment including radiotherapy, chemotherapy, and surgery.
- •Expected to achieve satisfactory tumor cytoreductive surgery.
- •Estimated lifetime is more than 3 months.
- •Understand the research plan and voluntarily participate in the study, sign the informed consent form.
- •Ability to collect specimens from each time point and provide corresponding clinical information.
排除标准
- •Patients who will receive new adjuvant therapy.
- •Patients who have other primary cancer.
- •Pregnant or breast-feeding woman.
- •Patients with severe mental illness.
- •Patients achieve unsatisfactory tumor cytoreductive surgery.
- •Patients who voluntarily withdraw for any reason.
- •Patients who cannot complete the research plan.
结局指标
主要结局
The ctDNA characteristics in patients with ovarian cancer , the correlation between the clonal status of mutations and therapy response and whether ctDNA detection can be used to predict the risk of ovarian cancer recurrence.
时间窗: 2 years
次要结局
- The proportion of hereditary tumors in ovarian cancer patients in China, as well as the spectrum of variations and the characteristics of immune repertoire before and after treatment in patients with ovarian cancer.(1 years)