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临床试验/NCT01391351
NCT01391351已完成不适用

Search for Predictors of Therapeutic Response in Patients With Carcinoma of the Ovary, the Fallopian Tube or Peritoneal Serous-type Advanced

Centre Francois Baclesse14 个研究点 分布在 1 个国家目标入组 107 人开始时间: 2011年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
107
试验地点
14
主要终点
search for predictors of response to chemotherapy

研究概览

简要总结

In order to search for predictors of response to chemotherapy in patients with ovarian carcinoma of the ovary, the fallopian tube or peritoneal serous-type advanced stage, we will define the comparative profiles of miRNA expression of serum polymorphisms and determine differential in 2 patient populations (with or without recurrence 6 months after completion of chemotherapy) with (i) the miRNA profile of serum before treatment and (ii) identification of polymorphisms or SNP (Single Nucleotide Polymorphism) in particular genes involved in the metabolism of chemotherapy agents In the case of miRNA, expression profiles will also be studied during the first course in response to chemotherapy. Indeed, the miRNA profile of serum may be different at baseline among the 2 types of populations (or non-recurrence at 6 months).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
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

  • Patients with cancer of the ovary, peritoneum or of the fallopian tube
  • Stage III or IV
  • Cancer of serous histology
  • Patients of any chemotherapy naive
  • Patients should receive treatment with chemotherapy for first line by Taxol- Carboplatin. Avastin is authorized in concomitant.
  • An initial surgery or through authorized
  • Patients who signed informed consent
  • Patients over the age of 18 years

排除标准

  • Patients being treated for another cancer chemotherapy and / or hormone therapy
  • Patients receiving other chemotherapy Taxol-carboplatin associated or not to avastin
  • Patients under guardianship
  • Previous history of pelvic radiotherapy
  • History of malignancy blood

结局指标

主要结局

search for predictors of response to chemotherapy

时间窗: 12 months after beginning treatment

the search for predictors of response to chemotherapy in patients with carcinoma of the ovary, the fallopian tube or peritoneal serous-type advanced by using (i) the miRNA profile of serum before treatment with chemotherapy and (ii) the identification of polymorphisms or SNPs (Single Nucleotide polymorphism) in particular genes involved in the metabolism of chemotherapy agents

次要结局

  • profiling miRNA expression(1 month)
  • study of changes in serum miRNA expression(6 months)

研究者

发起方
Centre Francois Baclesse
申办方类型
Other
责任方
Sponsor

研究点 (14)

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