Density-indicated mammographic-sonographic breast cancer screening
Not Applicable
Recruiting
- Conditions
- C50Malignant neoplasm of breast
- Registration Number
- DRKS00019097
- Lead Sponsor
- Referenzzentrum Mammographie München
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 30000
Inclusion Criteria
(1) Participant of the German mammography-screening program, (2) age between 50 and 69 years, (3) breast density in the upper 15% range, (4) informed written consent.
Exclusion Criteria
(1) No informed written consent, (2) foreign substances or breast implants, (3) participation in another breast cancer study.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To identify the additional cancer diagnoses due to extra ultrasound examination per 1000 women. Follow-up examinations (imaging studies, biopsies) and false-positive results will also be determined.
- Secondary Outcome Measures
Name Time Method Secondary objectives are: (1) To find an upper threshold, above which the additional ultrasound could be appropriate, while false-positive results are kept as low as possible. (2) To assess the acceptance and feasibility of the additional examination. (3) To estimate additional costs or savings by carrying out a health economic simulation.