C50
Conditions
Interventions
Group 1: Breast density is measured objectively. If breast density is in the upper 15% range, an extra ultrasound examination will be performed in addition to mammography.
Group 2: Breast density is m
Sponsors
Referenzzentrum Mammographie München
Eligibility
Sex/Gender
Female
Age
50 Years to 69 Years
Inclusion criteria
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
Exclusion criteria: (1) No informed written consent, (2) foreign substances or breast implants, (3) participation in another breast cancer study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Germany
Contacts
Public ContactEva Mieskes
Referenzzentrum Mammographie München
Outcome results
None listed