跳至主要内容
临床试验/NCT02133222
NCT02133222已完成不适用

Circulating Cell-free DNA in Metastatic Melanoma Patient: Mutational Analyses in Consecutive Measurement Before and After Chemotherapy.

Centre Hospitalier Universitaire de Nice2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2014年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
22
试验地点
2
主要终点
Response to treatment (MRI, Scanner)

研究概览

简要总结

Therapies that target specific molecules markedly inhibit cancer growth in several malignancies, and provide valuable strategies for the treatment of advanced melanoma. In recent years, BRAF and KIT have become established therapeutic targets in melanoma patients showing activating mutations in these oncogenes. However, it is crucial that genetic mutations present in the melanoma lesions are identified if the investigators are to design tailormade therapies for individual patients. The tumour genotypes that determine the selection of molecular-targeted therapies are usually identified in primary tumours; however, primary tumours are not always representative of metastases. Circulating free DNA may be a source of valuable information because it can be obtained via routine blood sampling, it provides real-time information about a patient's current disease state, and it allows monitoring and molecular characterization before and after chemotherapy. The aim of the study is to determine the mutational status in circulating DNA in melanoma metastatic patients, with the Sequenom Mass Array, a next generation sequencing technology. Results obtained before and after treatment will be compared with the primary tumor genotype.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Screening
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age>18 years
  • Surgical biopsy for histologic diagnostic
  • All melanoma subtypes
  • Known genotype BRAF V600
  • Affiliation social security
  • Consent form signed

排除标准

  • Patient with histories of cancer or the other synchronous cancer
  • Pregnant women
  • Breast-feeding women
  • Vulnerable patients: major under guardianship; patient deprived of its rights

结局指标

主要结局

Response to treatment (MRI, Scanner)

时间窗: at three months

Comparison between first day and third 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 (2)

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