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Stockholm Mammography Risk Stratified Trial
Sponsor: Karolinska Institutet
Summary
SMART is a Phase III, randomised, non-blinded screening trial. Women who consent to participate in SMART are randomised to either individualised screening or screening according to the Swedish National Breast Cancer Screening Program. Women randomised to individualised screening get their 2-year risk of breast cancer assessed and women with the highest short-term risk are offered contrast enhanced mammography and a mammogram at 12 months.
Key Details
Gender
FEMALE
Age Range
40 Years - 74 Years
Study Type
INTERVENTIONAL
Enrollment
70000
Start Date
2024-04-08
Completion Date
2032-04-08
Last Updated
2024-02-28
Healthy Volunteers
Yes
Conditions
Interventions
Risk based screening
Women randomised to the individualised screening arm and judged to be at high risk will be invited to a contrast enhanced mammography and a mammography after 12 months. The intervention is thus a different selection of women compared to what is done today.