Evaluation of Clonal Heterogeneity and Tumor Evolution Using Liquid Biopsy in Newly Diagnosed Patients With High Grade Adenocarcinoma of Ovarian Origin, Fallopian Tubes or Primary Peritoneal
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Using the concentration of cfDNA to predict disease events
研究概览
简要总结
BOVARY-CE is a monocentric, pilot, longitudinal, real-life study with a total duration of 36 months. The purpose of this study is to assess the feasibility of using liquid biopsy as a substitute for tissue multisampling, in order to describe clonal heterogeneity and tumor evolution in patients with ovarian cancer. The method involves the inclusion of 20 patients with high-grade ovarian adenocarcinoma, fallopian tubes or primary peritoneal origin, not pretreated, newly diagnosed, and eligible for treatment who will participate in the research. These patients will have several samples throughout their treatment for a period of 2 years: blood samples which will be taken at each therapeutic moment of interest.
Tissue samples which will be taken at the time of the diagnostic laparoscopy and at the time of surgery.
The concentration of cfDNA and tumor heterogeneity will be used to predict disease-related events defined as relapse, progression or death.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Age ≥ 18 years
- •Patient with non-treated high grade serous and endometrioid carcinoma of ovarian, fallopian tube, or primary peritoneal origin proven cytologically or histologically at inclusion and eligible for treatment
- •Patient eligible for an upfront surgery or pretherapeutic coelioscopy
- •Adequate haemoglobin rate ≥ 9 g/dL
- •Patient affiliated to a social security scheme
- •Ability to provide written informed consent
排除标准
- •Age < 18 years
- •Any concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study
- •Contraindication to blood samples of 20 mL
- •Pregnant or breast-feeding women
- •Ongoing treatment for the newly diagnosed cancer or the recurrence
- •Other cancers treated within the last 5 years
- •Patient under guardianship or curatorship or deprived of liberty
研究组 & 干预措施
Experimental
blood sample (20 ml) and biopsy
干预措施: Diagnostic Test (Other)
结局指标
主要结局
Using the concentration of cfDNA to predict disease events
时间窗: 12 months
cfDNA concentration (ng / µl)
次要结局
未报告次要终点