Cancer stage and diagnostic triggers as mortality surrogate to validate supplemental breast imaging use in women with dense breasts

项目摘要 该项目的长期目标是制定一个明确和充分的诊断评估 乳腺癌筛查作为女性乳房X光检查补充的潜在和非死亡结果 丰满的乳房。实现这一目标的目的是为调整当前的不足提供证据 调整提供的护理并告知保险覆盖范围的评估指南，特别是在较低的 资源设置。乳房密度是乳房发育最重要的危险因素之一。 癌症和乳房密度是30个州在某些方面强制向患者报告的。如果信息 在向患者提供识别风险增加的情况下，应同时提供额外护理的选项。 为乳腺癌风险增加的女性开发的补充筛查措施 包括乳房超声(US)、乳房磁共振成像(MRI)、数字乳房断层合成(DBT) 和分子乳房成像(MBI)。研究表明，这些模式具有更高的特异性 与乳房X光检查相比，联合乳房X光检查对肿瘤的敏感度更高。 然而，由于使用最少，而且FDA批准使用的时间很短，还没有显示出有 这些模式的使用大大降低了死亡率。评估的纵向研究 降低乳腺癌死亡率的疗效被认为是显示这些方法的好处所必需的， 但成本高昂，耗时长。因此，评估小说的效用和效益的其他方法 技术是必要的，并将使事实证明有益的技术得到更有效的实施。 尽管目前的指导方针没有足够的证据来建议使用新技术，但梅奥 临床正在实施筛查DBT和MBI在常规护理中的使用，这些患者是 最有可能从这些方式中受益的人是那些乳腺癌风险增加的人。梅奥诊所 还有一个27个县范围的数据共享努力，罗切斯特流行病学项目，它允许数据 从所有同意EMR研究的患者中提取。为此，这项提议的目的是 按顺序确定这些模式的诊断潜力(目标1)和非死亡结果(目标2) 开发一种独立于直接降低死亡率的评估方法，使用分期和症状 在诊断时，在有能力支持这项研究的环境中。完成这些目标可以 为新技术的实用性和更高效的实施提供框架和证据 癌症检测，潜在地规避了基于死亡率的纵向研究的需要。这个 参与本项目进展的跨学科协作和培训环境将支持 申请者的开发和研究经验，并将有助于推动她的职业生涯作为一名未来的临床科学家。

Project Summary The long term goal of this project is to develop a definitive and adequate assessment of the diagnostic potential and non-mortality outcomes of breast cancer screening in supplement to mammography for women with dense breasts. The purpose of achieving this goal is to provide evidence to adjust the current inadequate assessment guidelines that modulate care provided and inform insurance coverage, especially in lower resource settings. Breast density is one of the most significant risk factors for the development of breast cancer, and breast density is mandatorily reported to patients in some respect in 30 states. If information identifying increased risk is provided to patients, options for additional care should be provided simultaneously. Supplemental screening measures developed for use by women with an increased risk for breast cancer include breast ultrasound (US), breast magnetic resonance imaging (MRI), digital breast tomosynthesis (DBT) and molecular breast imaging (MBI). Studies have shown that these modalities have an increased specificity compared to mammography, and in conjunction with mammography have an increased sensitivity for tumors. However, with minimal use and short times from FDA approval for this use, it has not been shown that there has been a significant reduction in mortality with use of these modalities. Longitudinal studies assessing the efficacy of breast cancer mortality mitigation are thought to be necessary to show benefit of these modalities, but are costly and time consuming. Therefore, other methods for assessing the utility and benefit of novel technology are required, and will allow for more efficient implementation of technologies that prove beneficial. Regardless of current guidelines with insufficient evidence to recommend use of novel technologies, the Mayo Clinic is in the process of implementing use of screening DBT and MBI in routine care for patients who are the most likely to benefit from these modalities; those who are at increased risk of breast cancer. The Mayo Clinic also has a 27 county wide data sharing effort, the Rochester Epidemiology Project, which allows data abstraction from all patients consenting to EMR research. To that end, the purpose of this proposal is to characterize diagnostic potential (Aim 1) and non-mortality outcomes (Aim 2) for these modalities in order develop a method of assessment independent of direct mortality reduction, by using stage and symptomaticity at time of diagnosis in a setting with the capacity to support this research. Completion of these aims may provide a framework and evidence for the utility and more efficient implementation of new technologies in cancer detection, potentially circumventing the need for longitudinal mortality-based studies. The interdisciplinary collaboration and training environment engaged in the progress of this project will support the applicant’s development and research experience, and will help drive her career as a future clinician scientist.