NCT01333748已完成2 期
Search Allelic Imbalance of Expression of BRCA Genes in Hereditary Risk of Breast and/or Ovarian Cancer
Centre Francois Baclesse11 个研究点 分布在 1 个国家目标入组 530 人开始时间: 2010年4月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 530
- 试验地点
- 11
- 主要终点
- estimate the proportion of patients with allelic imbalance at the level of expression of BRCA1
研究概览
简要总结
The purpose of this study is to determine proportion of patients presented a search allelic imbalance of expression of genes BRCA 1 and 2 in population with hereditary breast and/or ovarian cancer risk and negative for deletion mutation BRCA 1 and 2 genes
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- 是
入选标准
- •For patients
- •Women with breast cancer and / or ovarian cancer meet criteria suggestive of a hereditary predisposition
- •Deleterious mutation of BRCA1 and BRCA2 sought and not highlighted
- •Age ≥ 18 years
- •Agreeing to participate in the study (a collection of signed informed consent)
- •For control population
- •Women with no history of breast and / or ovarian cancer and no family history of breast and / or ovarian cancer among family members on the 1st and 2nd degree before age 50 for breast cancer and before 60 years for ovarian cancer
- •Agreeing to participate in the study (a collection of signed informed consent)
排除标准
- •For patients:
- •Patients with a known deleterious mutation in BRCA1 and BRCA2
- •Patients do not meet criteria suggestive of a hereditary predisposition
- •Persons deprived of liberty or under guardianship (including guardianship)
- •For control population:
- •Personal or family history of breast and / or ovarian cancer (breast or ovarian cancer in their family experienced 1st and 2nd degree before age 50 for breast cancer before age 60 for cancer ovarian)
- •Persons deprived of liberty or under guardianship (including guardianship)
结局指标
主要结局
estimate the proportion of patients with allelic imbalance at the level of expression of BRCA1
时间窗: blood sample at baseline, no follow-up in this study
The main objective of this study is to estimate the proportion of patients with allelic imbalance at the level of expression of BRCA1 in a population meeting the criteria suggestive of a hereditary predisposition to breast and / or ovarian cancer , and negative for deleterious mutations of BRCA 1 and BRCA 2.
次要结局
- Study the variability of the measurement of the allelic expression depending on the position of SNPs(blood sample at baseline, no follow-up in this study)
- proportion of patients with allelic imbalance at the level of expression of the BRCA2 gene(blood sample at baseline, no follow-up in this study)
- Observe the possible effect of age(blood sample at baseline, no follow-up in this study)
研究者
研究点 (11)
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