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Stockholm Mammography Risk Stratified Trial

NCT06270355 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 70000

Last updated 2024-02-28

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

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.

Sponsors & Collaborators

Principal Investigators

  • Per Hall, Professor · Karolinska Institutet

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
74 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-04-08
Primary Completion
2028-04-08
Completion
2032-04-08

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06270355 on ClinicalTrials.gov