Evaluation of a Combined Breast Cancer Risk Derived From a Polygenic Risk Score and the Tyrer-Cuzick Model
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 553
- 试验地点
- 4
- 主要终点
- To demonstrate that a combined breast cancer risk derived from a polygenic risk score and a breast cancer risk assessment model is a better predictor of breast cancer than the risk assessment model alone
研究概览
简要总结
A prospective, non-interventional study in women 18 to 84 years of age. Subjects will provide a sample for genetic testing and information about their medical and family history. The results of the genetic test will be combined with clinical data to validate a method of predicting breast cancer risk.
详细描述
This is a prospective, non- interventional study. Women presenting at imaging centers for routine breast cancer screening or breast cancer diagnostic assessment and who provide written informed consent will undergo genetic testing. Subjects will also provide information about their personal medical and cancer history and family cancer history. The results of the genetic test will be combined with the subject's clinical information, family history, and a risk assessment model to validate a new method of predicting breast cancer.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 84 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women without breast cancer:
- •18 to 84 years of age
- •Western/Northern European, Central/Eastern European, or Ashkenazi ancestry
- •No history of invasive breast cancer
- •Women with a history of breast cancer:
- •18 to 84 years of age
- •Western/Northern European, Central/Eastern European, or Ashkenazi ancestry
- •Pathologically confirmed invasive breast cancer diagnosed within the past 12 months
排除标准
- •Unwilling to provide written informed consent
- •Women with history of ductal carcinoma in situ (DCIS).
- •Patient has had a prior breast biopsy, exclusive of a breast biopsy diagnostic of breast cancer, that showed either hyperplasia, atypical hyperplasia, lobular carcinoma in situ (LCIS), or the specific histologic result is unknown to the patient
结局指标
主要结局
To demonstrate that a combined breast cancer risk derived from a polygenic risk score and a breast cancer risk assessment model is a better predictor of breast cancer than the risk assessment model alone
时间窗: Baseline
次要结局
- To derive a distribution of polygenic risk scores in an unselected patient population(baseline)