Clinical trial · Interventional
Stockholm Mammography Risk Stratified Trial
NCT06270355CI-TRIAL-00074496SMARTnot yet recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Risk based screening | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental arm
- description
- Women randomised to the experimental arm / individualised screening will have their 2-year breast cancer risk assessed upfront. This is done via an AI (artificial intelligence) derived analyses of the mammograms. Women scored with the highest 2-year risk will be offered a contrast enhanced mammography and an additional mammography at 12 months.
- interventionNames
- Procedure: Risk based screening
- type
- ACTIVE_COMPARATOR
- label
- No intervention arm
- description
- The 35,000 women randomised to the no intervention arm will continue in the Swedish National Breast Cancer Screening Program. This means that they are invited for the next mammography screening after 24 months.
- interventionNames
- Procedure: Risk based screening
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 40 Years
- Maximum age
- 74 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.