Stockholm Mammography Risk Stratified Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 70,000
- 主要终点
- Incidence of interval cancers
研究概览
简要总结
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.
详细描述
Aims: The overarching aim of SMART is to compare the effectiveness of current screening practice with individualised breast cancer screening. In SMART women who recently had a normal mammogram will be randomised to either age based or individualised screening. Women randomised to individualised screening will have their 2-year breast cancer risk assessed upfront. This is done via an artificial intelligence (AI) 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. The possible benefits of individualised screening will be contrasted to the possible harms defined as unnecessary recalls, biopsies and induced anxiety and worry.
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 74 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Incidence of interval cancers
时间窗: 24-month
For women at high 2-year risk in the intervention arm interval cancers are defined as cancers diagnosed in the interval between 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.
次要结局
- Number of recalled women(24-month)
研究者
Per Hall
Professor, PhD, MD
Karolinska Institutet