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临床试验/NCT02222883
NCT02222883已完成不适用

Prevalence of BRCA in Patients With Primary or Platinum Sensitive Recurrent Ovarian Cancer.

AGO Research GmbH19 个研究点 分布在 1 个国家目标入组 530 人开始时间: 2015年3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
530
试验地点
19
主要终点
Germline alterations in BRCA1/2 (yes/no) and other ovarian cancer predisposing genes (yes/no; if yes which)

研究概览

简要总结

The aim of this prospective registration and translational research study is to evaluate the praevalence of BRCA regarding germline and somatic mutations.

详细描述

Explorative analysis will be performed.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Female ovarian cancer patients aged >= 18 years.
  • Women with first diagnosis of epithelial ovarian cancer OR women diagnosed with platinum-sensitive recurrent ovarian cancer.
  • Multiple platinum based prior therapies are allowed.

排除标准

  • Non-epithelial ovarian malignancy.
  • Platinum-resistant or refractory disease.
  • Paraffin embedded tumor samples not available.

结局指标

主要结局

Germline alterations in BRCA1/2 (yes/no) and other ovarian cancer predisposing genes (yes/no; if yes which)

时间窗: once per sample

次要结局

  • Results of Immunohistochemistry in tumor samples(once per sample)
  • Patient Survey for perspectives and satisfaction regarding testing and counseling(once after BRCA result is available)
  • Determining the correlation of genetic alterations, cancer treatments, overall survival, progression-free survival and occurrence of new malignancies(once)
  • Somatic alterations in BRCA1/2 (yes/no) and other ovarian cancer predisposing genes (yes/no; if yes which)(once per sample)
  • BRCAness tumor phenotype in ovarian cancer (yes/no).(once per sample)
  • Differences of tumor samples from primary and relapsed disease(once per sample for each stage of disease)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (19)

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