Stockholm Mammography Risk Stratified Trial

Launched by KAROLINSKA INSTITUTET · Feb 20, 2024

Keywords

ClinConnect Summary

The Stockholm Mammography Risk Stratified Trial (SMART) is a study focused on improving breast cancer screening for women. In this trial, women aged 40 to 74 who choose to participate will be randomly assigned to one of two groups: one will receive personalized screening based on their individual risk of developing breast cancer, while the other will follow the standard screening guidelines set by the Swedish National Breast Cancer Screening Program. Women identified as having a higher short-term risk will get a special type of mammogram called contrast-enhanced mammography, along with a regular mammogram a year later.

To be eligible for this trial, participants must be women aged 40 to 74, able to use a smartphone or tablet with a specific identification app called BankID, and must have signed an informed consent form. However, women who are pregnant, breastfeeding, have had previous breast cancer, or have certain health conditions that could affect their safety are not eligible. This trial aims to provide a more tailored approach to breast cancer screening, which could lead to earlier detection and better outcomes for women at higher risk. If a participant cannot undergo the contrast mammogram, they will be offered an automated ultrasound instead.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Have read, understood and signed the informed consent
• • Perform breast cancer screening at Södersjukhuset
• • Females in the age range 40 - 74 years at baseline mammography
• • Using a smartphone or tablet with BankID
• Exclusion Criteria:
• • Pregnant, breast feeding or planning to become pregnant.
• • Previous breast cancer
• • A medical condition that according to the responsible physician would negatively affect the health of the women.
• • Cognitive impairment and / or language ability that would make it difficult for the participant to understand the implication of study and to perform a contrast mammography.
• • For women that will be offered contrast enhanced mammography the clinically accepted and applied exclusion criteria will be used. Women who cannot perform a contrast mammography will be offered an automated ultrasound.