Clinical Pilot Study for Personalized Risk-based Breast Cancer Screening
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Assessment of breast cancer risk by polygenetic risk score in the study population
研究概览
简要总结
The study aims to evaluate the impact of implementing population-based genetics testing strategy for breast cancer precision prevention using the polygenic risk score and monogenic pathogenic variant (MPV) testing in the Norwegian healthcare setting.
详细描述
The study will recruit women age 40-50 referred for clinical mammography at the Vestre Viken Breast Center, with mammographic density BI-RADS a or d. After informed consent, saliva from the participants will be sampled and tested for polygenetic risk score (PRS) for breast cancer. The participants will be recommended future mammographic screening based on the PRS (standard screening, or more frequent/start at earlier age). The participants family history of cancer will be assessed, and if indicated, the participants will be referred for full genetic counselling/testing. The study will follow the women for 10 years for development of breast cancer as well as compliance to the recommended follow-up.
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
- 40 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women referred for clinical mammography in the Vestre Viken Breast Centre
- •Breast density BI-RADS a or d
- •40-50 y.o.
排除标准
- •Prior history of breast cancer or premalignant breast disease
- •Prior genetic counselling/testing
结局指标
主要结局
Assessment of breast cancer risk by polygenetic risk score in the study population
时间窗: 10 years
Polygenetic breast cancer risk score (PRS) as a numeric value with 10 percentile, as absolute 10-year breast cancer risk, and as relative risk compared with average women at the same age
次要结局
- Compliance to individual recommedations for breast cancer screening(10 years)
- Correlation of polygenetic risk score and breast cancer risk assessed by family history(10 years)
- Participants´ experience with study participation(10 years)