PERsonalized Mammographic Screening in Norway; Additional Examination for Women With Increased Risk of Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 3,000
- 主要终点
- Attendance rate to extra imaging with digital breast tomosynthesis for women with extremely high mammographic density
研究概览
简要总结
The aim of this study is to assess attendance among women invited to additional breast imaging because they were identified as having an increased risk of breast cancer at screening. High-risk women were defined in two studies: Study A; women with high mammographic density, representing approximately 3-5% of screened women, and Study B; women with a false-positive screening result. Women in Study A will be offered an additional screening examination with digital breast tomosynthesis immediately within 6 months after the screening examination. Women in Study B will be offered an additional standard digital mammography examination one year after their initial screening.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 71 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •invited to screening
- •extremely dense breast (Study A) or a false positive screening result (Study B)
排除标准
- •Opted out or not signed written consent related to the study
- •Women who have opted out from giving us permission to use screening data for quality assurance and research
研究组 & 干预措施
Women attending mammographic screening at three sites in BreastScreen Norway
Those 3-5% with the highest mammographic density in Study A and those with a false positive screening result in Study B will be offered additional imaging with digital breast tomosynthesis within 6 months after the screening examination (A) and an additional standard screening examination after one year (B)
结局指标
主要结局
Attendance rate to extra imaging with digital breast tomosynthesis for women with extremely high mammographic density
时间窗: Women will be invited to the extra examination with DBT within 6 months after index screening mammography.
Women with extremely dense breasts will be offered an extra examination with DBT within 6 months after index screening mammography. The investigators will assess the attendance rate to this extra examination.
Attendance rate to an additional screening mammography for women with false positive screening result
时间窗: Women will be invited to the additional screening mammography within 12 months after index screening mammography.
Women with false positive screening result will be offered an additional screening mammography within 12 months after index screening mammography. The investigators will assess the attendance rate to this additional examination.
次要结局
未报告次要终点