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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

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.

修改后的项目摘要/摘要部分乳房密度是患乳腺癌的风险因素，降低了乳房X光检查的准确性。据估计，美国有2700万年龄在40岁至74岁之间的女性乳房致密，她们的晚期乳腺癌诊断率较高，而预后较差。现在有37个州要求乳房X光检查设施通知乳房致密的女性乳房X光检查的局限性，并建议与医疗保健提供者讨论筛查选项，一项全国性的法律正在酝酿之中。在缺乏乳房致密妇女筛查指南的情况下，补充超声筛查的使用大幅增加，这种筛查方法随处可见，而且直接医疗成本较低。早期对补充超声表现的研究表明，癌症检测增加了，但假阳性检查的比率很高，导致了不必要的活检。美国预防服务工作组呼吁开展研究，评估补充超声筛查对晚期癌症发病率等有意义的临床结果的影响，为乳房致密的女性提供筛查指南。我们最近证明，在乳房致密的女性中，乳房致密的筛查失败率(即晚期癌症和正常乳房X光检查后的间歇性癌症)随着临床风险因素的不同而有很大差异。因此，我们建议在一个新的基于风险的框架内评估补充超声筛查的性能。我们假设，针对乳房致密、乳房X光检查失败风险较高的女性的补充超声筛查将产生有利的益处-伤害概况。我们将使用通过乳腺癌监测联盟收集的100,000多次筛查超声检查和200万次乳房X光检查的观察数据，(目标1)根据主要筛查类型(数字乳房X光检查与数字乳房断层扫描)检查补充检查超声波的测试性能；以及(目标2)评估针对乳房X光检查失败风险水平的补充筛查超声结果。这些结果将被用作癌症干预和监测建模网络(AIM 3)的两个模拟模型的输入，以评估针对乳房X光检查失败高风险女性的补充超声策略的长期益处、危害和成本。我们的研究将是对补充超声的最大评估，并首次根据乳房X光检查失败的风险评估间歇性癌症和晚期癌症的比率。我们的结果将为女性、医疗保健提供者和指南制定者评估乳房致密女性的筛查选择提供迫切需要的、可操作的证据。这一证据将支持有效的补充筛查策略，在减少潜在危害的同时，减轻乳房X光检查不够充分的妇女患乳腺癌的负担。