NCT01992471已完成不适用
Multiplex Testing for Breast Cancer Susceptibility: A Pilot Study of Subject Preferences for Information and Responses After Testing
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 197
- 试验地点
- 1
- 主要终点
- women's preferences with respect to the type of information they would like to receive from multiplex testing
研究概览
简要总结
The purpose of this study is to find out what kinds of information people would like to receive from a new kind of genetic testing, and how they respond to this new kind of testing.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Male or Female age 18 or older
- •Personal history of breast cancer AND one of the following:
- •Invasive breast cancer or DCIS diagnosed at or before age 45 Invasive breast cancer diagnosed at/before age 50 with one or more of the following:
- •Limited family history (Fewer than 2 first- or second-degree female relatives in the same lineage that lived to age
- •The "limited family history" can occur on either the maternal or paternal side of the family.)
- •1 or more first-/second-degree relatives with invasive BC at/before 50
- •1 or more first-/second-degree relatives with invasive epithelial ovarian cancer (any age)
- •1 or more first- or second-degree relatives with male breast cancer
- •2 or more first- or second-degree relatives with pancreas cancer
- •Invasive breast cancer diagnosed at or before age 60 with at least 2 first or second-degree relatives affected with any combination of invasive breast cancer before age 50, invasive epithelial ovarian cancer at any age, male breast cancer, or pancreas cancer.
- •Full sequence BRCA1 and BRCA2 testing completed with no deleterious mutation identified.
排除标准
- •Unable to provide informed consent for testing
- •Unable to complete English language questionnaire
结局指标
主要结局
women's preferences with respect to the type of information they would like to receive from multiplex testing
时间窗: 2 years
Proportions of subjects declaring a pre-test preference to receive 1) all available information, 2) all information related to breast cancer predisposition (whether or not clinical utility is established), 3) all information of established clinical utility (whether related to breast cancer risk or not), 4) only a subset of high-penetrance information (masking certain results), 5) no information.
次要结局
未报告次要终点
研究者
研究点 (1)
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