Can we use breast density measurement to indicate whether mammography or MRI can best be used to screen women with familial risk for breast cancer?
Recruiting
- Conditions
- Breast Cancer, Neoplasm Mammae, Screening, MRI, Mammography, Breast DensityBorst kanker, Neoplasma Mammae, Screening, MRI, mammografie, borstdensiteit
- Registration Number
- NL-OMON28552
- Lead Sponsor
- Erasmus MC, Daniel den Hoed Clinic, Faculty of Medicine, Department of Surgical Oncology
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 2000
Inclusion Criteria
1. Cumulative Life Time Risk ≥20%, defined by Claus Adjusted Tables;
2. Age at inclusion 30-55 years, or 5 years younger than youngest case of breast cancer in family;
Exclusion Criteria
1. Personal history of invasive (breast) cancer, except for basal cell carcinoma;
2. Having a (50% risk of a) known BRCA1, BRCA2 or P53 mutation;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The number of tumours detected at screening examinations and in between screening examinations (interval tumours), and the stage distribution at diagnosis in the different trial arms. The results will also be analyzed by density score.
- Secondary Outcome Measures
Name Time Method Sensitivity, proportion of false-positive results and specificity of MRI and mammography in both arms. Furthermore breast cancer mortality reduction will be estimated using breast cancer microsimulation models (MISCAN). Cost effectiveness analyses will be performed. Costs will be calculated per quality adjusted life-year gained.