Prognostic and Predictive Biomarkers in Ovarian Cancers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- Progression Free Survival
研究概览
简要总结
The investigators therefore propose to conduct a biological study of prospectively collected patient tumour samples, ascites, blood and other residual samples (feces, urine, vaginal smear) throughout the disease course where markers (at diagnosis and their change with treatment) will be correlated to outcome in order to investigate how genetic diversity in OC prior to treatment and adaptation following treatment contribute to chemotherapy resistance. In addition freshly collected ascitic samples (and tumour samples) will be subjected to ex vivo DNA repair functional assays and isolated in primary culture (and established as xenografts) for target validation experiments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •New patient with a diagnosis of OC, or
- •Previously treated patient with frozen or formalin fixed paraffin embedded primary tumour sample available that can be retrieved by the center presenting with progressive disease, and consenting to CT guided biopsy of relapsed disease, or
- •Previously treated patient with frozen or formalin fixed paraffin embedded primary tumour sample available that can be retrieved by the center scheduled for surgery for relapsed disease.
- •Signed informed consent
- •Patient affiliated to a social security regimen or beneficiary of the same
排除标准
- •Patients who do not fit the inclusion criteria and those who refuse an antitumoral treatment;
- •Coagulation abnormalities that contra-indicates the biopsy
结局指标
主要结局
Progression Free Survival
时间窗: Correlation of baseline biomarkers with PFS will occur at 12 months following last patient inclusion
up to 12 months
次要结局
未报告次要终点
