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临床试验/NCT03010124
NCT03010124招募中不适用

Prognostic and Predictive Biomarkers in Ovarian Cancers

Gustave Roussy, Cancer Campus, Grand Paris1 个研究点 分布在 1 个国家目标入组 350 人开始时间: 2016年9月26日最近更新:
适应症

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

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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