Identifying effective risk-based supplemental ultrasound screening strategies for women with dense breasts

为乳房致密的女性确定有效的基于风险的补充超声筛查策略

基本信息

批准号：
10113566
负责人：
Brian L Sprague
金额：
$ 67.5万
依托单位：
UNIVERSITY OF VERMONT & ST AGRIC COLLEGE
依托单位国家：
美国
项目类别：
财政年份：
2020
资助国家：
美国
起止时间：
2020-03-01 至 2025-02-28
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10113566
关键词：
Advanced Malignant Neoplasm Advisory Committees Awareness Biopsy Breast Breast Cancer Detection Breast Cancer Model Breast Cancer Risk Factor Breast Cancer Surveillance Consortium Cancer Detection Cancer Intervention and Surveillance Modeling Network Cancer Model Characteristics Clinic Clinical Clinical Data Computer Simulation Confusion Data Databases Decision Making Diagnostic Imaging Digital Breast Tomosynthesis Digital Mammography Effectiveness Evaluation Failure Geography Guidelines Health Personnel High Risk Woman Image Laws Letters Link Malignant Neoplasms Mammary Gland Parenchyma Mammary Ultrasonography Mammographic Density Mammographic screening Mammography Medical Care Costs Modality Notification Outcome Pathology Performance Policy Maker Positioning Attribute Preventive service Provider Quality-Adjusted Life Years Radiology Specialty Recommendation Regional Cancer Registries Research Infrastructure Risk Risk Factors Techniques Testing Ultrasonography United States Woman Work advanced breast cancer aged base breast cancer diagnosis breast density breast exam breast imaging clinical practice clinical risk comparative effectiveness cost density experience high risk malignant breast neoplasm models and simulation mortality multidisciplinary neoplasm registry network models novel performance tests personalized screening response screening screening guidelines supplemental screening

Advanced Malignant Neoplasm Advisory Committees Awareness Biopsy Breast Breast Cancer Detection Breast Cancer Model Breast Cancer Risk Factor Breast Cancer Surveillance Consortium Cancer Detection Cancer Intervention and Surveillance Modeling Network Cancer Model Characteristics Clinic Clinical Clinical Data Computer Simulation Confusion Data Databases Decision Making Diagnostic Imaging Digital Breast Tomosynthesis Digital Mammography Effectiveness Evaluation Failure Geography Guidelines Health Personnel High Risk Woman Image Laws Letters Link Malignant Neoplasms Mammary Gland Parenchyma Mammary Ultrasonography Mammographic Density Mammographic screening Mammography Medical Care Costs Modality Notification Outcome Pathology Performance Policy Maker Positioning Attribute Preventive service Provider Quality-Adjusted Life Years Radiology Specialty Recommendation Regional Cancer Registries Research Infrastructure Risk Risk Factors Techniques Testing Ultrasonography United States Woman Work advanced breast cancer aged base breast cancer diagnosis breast density breast exam breast imaging clinical practice clinical risk comparative effectiveness cost density experience high risk malignant breast neoplasm models and simulation mortality multidisciplinary neoplasm registry network models novel performance tests personalized screening response screening screening guidelines supplemental screening

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项目摘要

Modified Project Summary/Abstract Section Breast density is a risk factor for developing breast cancer and decreases the accuracy of screening mammography. An estimated 27 million women aged 40-74 in the U.S. have dense breasts and they experience elevated rates of advanced stage breast cancer diagnoses associated with poor outcomes. Thirty-seven states now require mammography facilities to notify women with dense breasts of the limitations of mammography and recommend discussion of screening options with their healthcare providers, and a national law is pending. In the absence of screening guidelines for women with dense breasts, there has been a dramatic increase in use of supplemental ultrasound screening, which is widely available and has low direct medical costs. Early studies of supplemental ultrasound performance suggest increased cancer detection but high rates of false positive exams leading to unnecessary biopsies. The United States Preventive Services Task Force has called for studies that evaluate the impact of supplemental ultrasound screening on meaningful clinical outcomes, such as advanced cancer rates, to inform screening guidelines for women with dense breasts. We recently demonstrated that mammography screening failure rates (i.e., advanced cancers and interval cancers after a normal mammogram) among women with dense breasts vary widely according to clinical risk factors. Therefore, we propose to assess supplemental ultrasound screening performance within a new risk-based framework. We hypothesize that supplemental ultrasound screening targeted to the subset of women with dense breasts at high risk of mammography screening failures will yield a favorable benefit-to-harm profile. We will use observational data from more than 100,000 screening ultrasound exams and 2 million mammography screening exams collected via the Breast Cancer Surveillance Consortium to (Aim 1) examine the test performance of supplemental screening ultrasound according to type of primary screening (digital mammography vs. digital breast tomosynthesis); and (Aim 2) evaluate supplemental screening ultrasound outcomes across levels of risk for mammography screening failures. These results will be used as inputs in two simulation models from the Cancer Intervention and Surveillance Modeling Network to (Aim 3) evaluate the long-term benefits, harms, and costs of supplemental ultrasound strategies targeted to women at high risk of mammography screening failures. Our study will be the largest evaluation of supplemental ultrasound and the first to evaluate rates of interval and advanced cancers according to risk of mammography screening failures. Our results will provide urgently needed, actionable evidence for women, healthcare providers, and guideline-makers evaluating screening options for women with dense breasts. This evidence will support effective supplemental screening strategies that reduce the burden of breast cancer among women for whom mammography screening is not adequate, while minimizing potential harms.

修改的项目摘要/摘要部分乳房密度是发展乳腺癌的危险因素，并降低了筛查乳房X线摄影的准确性。美国估计有2700万名40-74岁的妇女的乳房密集，并且与预后不良有关的晚期乳腺癌诊断率升高。现在，三十七个州需要乳房X线照相设施，将乳房X线摄影的局限性通知乳房的妇女，并建议与他们的医疗保健提供者讨论筛查选择，并正在审理国家法律。在没有针对乳房密集的女性筛查指南的情况下，补充超声筛查的使用急剧增加，这是广泛可用的，直接医疗费用较低。补充超声表现的早期研究表明，癌症检测增加，但假阳性检查率很高，导致不必要的活检。美国预防服务工作队呼吁进行研究，以评估补充超声检查对有意义的临床结果（例如晚期癌症）的影响，以告知对乳房密集的女性的筛查指南。我们最近证明，根据临床危险因素，乳房X线摄影筛查失败率（即正常乳房X光检查后的晚期癌症和间隔癌症）的差异很大。因此，我们建议在新的基于风险的框架内评估补充超声筛查性能。我们假设针对具有高乳房乳腺X线摄影筛查失败风险的乳房的子集的补充超声筛查将产生有利的利益对损害的特征。我们将使用超过100,000次筛查超声检查的观察数据和通过乳腺癌监测财团收集的200万次乳房X线摄影筛查检查，以检查（AIM 1）根据原发性筛查类型（数字乳腺检查与数字乳腺乳房乳房合成的类型）检查补充筛查超声检查的测试性能）；（AIM 2）评估乳房X线摄影筛查失败风险水平的补充筛查超声结果。这些结果将用作来自癌症干预和监视模型网络的两个模拟模型的输入，以评估针对乳房X线摄影筛查失败的高风险女性的补充超声策略的长期收益，危害和成本。我们的研究将是对补充超声检查的最大评估，也是第一个根据乳房X线摄影筛查失败的风险评估间隔和晚期癌症率的评估。我们的结果将为妇女，医疗保健提供者和准则制定者提供急需的，可行的证据，以评估乳房密集的妇女的筛查选择。该证据将支持有效的补充筛查策略，以减轻乳房X线摄影筛查不足的女性的乳腺癌负担，同时最大程度地减少潜在危害。