Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
PHASE3
70000 participants
INTERVENTIONAL
2024-04-08
2032-04-08
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
KARMA Kontrast Evaluating Contrast Enhanced Mammography in Early Detection of Breast Cancer
NCT04579107
Prognostic and Predictive Factors for Small Breast Tumors
NCT03390608
The Swedish Two-County Trial of Mammography Screening
NCT03217539
S1703 Serum Tumor Marker Directed Disease Monitoring in Patients With Hormone Receptor Positive Her2 Negative Metastatic Breast Cancer
NCT03723928
Using AI to Select Women for Supplemental MRI in Breast Cancer Screening
NCT04832594
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Primary Objectives: The primary benefit endpoint is a comparison of the proportion of interval cancers in the intervention and comparison group. The primary safety endpoint is the number of screen-initiated recalls and biopsies which do not lead to a cancer diagnosis.
Secondary Objectives: The secondary benefit endpoint is a comparison of the tumor characteristics of diagnosed cancers in the intervention and comparison group. The investigators will also compare differences in cancer worry, anxiety and / or depression between the intervention and control groups.
Explorative Objectives: To describe the possible side effects related to contrast enhanced mammography and compare them to those experienced after an ordinary mammogram. Cost-effectiveness as measured using incremental cost-effectiveness ratio and willingness-to-pay amount.
Primary Endpoint: For women at high 2-year risk in the intervention arm interval cancers are defined as cancers diagnosed in the interval between contrast enhanced mammography (CEM) and 12-month mammogram plus in the interval between 12- and 24-month interval. For the remaining women in the trial interval cancers are defined as cancers diagnosed between baseline mammography and 24-month mammography.
Information on date of diagnosis and mode of detection (screen detected or interval cancer) is derived from the National Quality Registry for Breast Cancer. To certify the correct diagnosis, the investigators will also use the electronic medical records, Take Care, at Södersjukhuset. Information on number of recalled women and number of biopsies will gathered from the Radiation Information System at the hospital.
Secondary Endpoint: Information on date of diagnosis and tumour characteristics (eg. stage, receptor status) is derived from the National Quality Registry for Breast Cancer. The investigators will compare how the screening modalities are perceived using answers from the self-reported Cancer Worry Scale and State Trait Anxiety Inventory.
Explorative Endpoint: The possible side effects related to contrast enhanced mammography and ordinary mammography will be identified using the self-reported Test Morbidity Index.
Study design: 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.
Study population: Women invited for screening according to the Swedish National Breast Cancer Screening Program at Södersjukhuset, that is, age range 40 - 74 years of age, will be invited to participate in SMART.
Number of included participants: Participants will be matched 1:1 with 35,000 women in each arm.
Intervention: 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.
Study Duration: There will be two database locks in SMART. The primary lock is done after approximately four years and two months. Women participating in SMART are part of the initial recruitment phase for a total of two years. They perform mammograms at baseline and 24 months. Adding the 2 year follow up for the lastly recruited participant makes a full trial period 4 years in total, with a further two months allowed to capture women whose scan is delayed. After two months the investigators will consider that screening visit to have been missed. The number of high-risk women will be slightly more than 6,000 in each arm (see 10.1 Population / Power). In addition, a second data lock will be performed after 8 years and two months from the start of the trial, that is, after a fourth round of screens (baseline plus 3 routine follow up mammograms). The same objectives and endpoints will be addressed as after the first data base lock with the exception of questionnaire data. Questionnaire data will only be collected between baseline and the next screen in 24 months. SMART will start in 2024, recruit women for 2 years and follow all women for 6 years. The study will thus end in 2032.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Experimental arm
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.
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.
No intervention arm
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
40 Years
74 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Karolinska Institutet
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Per Hall
Professor, PhD, MD
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Per Hall, Professor
Role: PRINCIPAL_INVESTIGATOR
Karolinska Institutet
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2023-06555-01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.