National Screening i Danmark Med MR-scanning af Brystet Kontra Klinisk Mammografi Hos Kvinder Der er bærere af Risikogivende BRCA1 Eller BRCA2 Mutationer
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 300
- 试验地点
- 5
- 主要终点
- Diagnostic outcome of a yearly screening with MR versus combined mammography and ultrasound of the breast measured by accuracy, sensitivity, specificity, positive and negative predictive values.
研究概览
简要总结
The purpose of the study is to determine whether MR of the breast is a better screening tool than mammography combined with ultrasound of the breast in women with BRCA1 or BRCA2 gene mutations.
详细描述
Study type : Interventional Study design: Diagnostic,Prospective,Non Randomised,Blinded,Efficacy study
Further study details as provided by DBCG ( Danish Breast Cancer Cooperative Group):
Primary outcome measures:
Diagnostic outcome of a yearly screening with MR versus combined mammography and ultrasound of the breast measured by accuracy, sensitivity, specificity, positive and negative predictive values.
Secondary outcome measures:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women tested positive of BRCA1 or BRCA2 gene mutations
- •referred for screening
- •aged 25 - 70 years
排除标准
- •general contraindications for MR
- •pregnant or lactating
- •bilateral mastectomy
- •ongoing treatment with chemotherapy
- •metastatic breast cancer
- •previous breast surgery less than 6 months before MR
- •previous radiation therapy of the breast less than 1 year before
- •incapable of managing her own affairs
结局指标
主要结局
Diagnostic outcome of a yearly screening with MR versus combined mammography and ultrasound of the breast measured by accuracy, sensitivity, specificity, positive and negative predictive values.
时间窗: 3 years
次要结局
- Comparison of the cancers found in women with BRCA gene mutations compared with the cancers found in the background population in respect of morphology, size, histological type, axillary lymph node status and grade.(3 years)
- Comparison of diagnostic outcome of MR versus combined mammography and ultrasound, in women with dense breast tissue compared with women with fatty breast tissue.(3 years)