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

癌症分期和诊断触发因素作为死亡率替代指标，以验证补充乳腺成像在致密乳房女性中的应用

• 批准号: 10316223
• 负责人: Susanna Nila Basappa
• 金额: $ 5.18万
• 依托单位: MAYO CLINIC ROCHESTER
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-01-01 至 2023-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10316223
• 关键词: Advisory Committees; Age; Biopsy; Breast; Breast Cancer Detection; Breast Cancer Risk Factor; Breast Magnetic Resonance Imaging; Cancer Detection; Caring; Cessation of life; Characteristics; Clinic; Clinical; Consent; Consumption; County; Data; Data Set; Detection; Development; Diagnosis; Diagnostic; Diagnostic Imaging; Digital Breast Tomosynthesis; Disease; Early Intervention; Environment; Epidemiology; Frequencies; Future; Goals; Guidelines; Image; Insurance Coverage; Investigation; Lead; Lesion; Longitudinal Studies; Malignant - descriptor; Malignant Neoplasms; Mammary Gland Parenchyma; Mammary Ultrasonography; Mammographic screening; Mammography; Mandatory Reporting; Masks; Measures; Methods; Modality; Molecular; Nature; Neoplasm Metastasis; Outcome; Patient Care; Patients; Population; Preventive service; Process; Research; Research Support; Resource-limited setting; Risk; Risk Factors; Scientist; Screening for cancer; Specificity; Survival Rate; Techniques; Testing; Time; Tissues; Training; Woman; base; breast cancer diagnosis; breast cancer survival; breast density; breast exam; breast imaging; cancer type; career; cohort; cost; data sharing; density; detection method; early screening; evidence base; experience; imaging modality; innovation; interdisciplinary collaboration; malignant breast neoplasm; mortality; new technology; novel; novel strategies; open source; premalignant; prevent; primary endpoint; research and development; routine care; routine screening; screening; supplemental screening; technology validation; tumor; ultrasound

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.

项目摘要 该项目的长期目标是对诊断性疾病进行明确和充分的评估。 女性乳腺癌筛查补充乳腺X线摄影的潜在和非死亡结局 有着高密度的乳房实现这一目标的目的是为调整目前的不足提供依据 评估指导方针，调整提供的护理，并告知保险范围，特别是在较低的 资源设置。乳腺密度是影响乳腺发育的重要危险因素之一 在30个州，在某些方面必须向患者报告乳腺密度。如果信息 在向患者提供确定增加的风险时，应同时提供额外护理的选择。 为乳腺癌风险增加的妇女制定的补充筛查措施 包括乳房超声（US）、乳房磁共振成像（MRI）、数字乳房断层合成（DBT） 分子乳腺成像（MBI）研究表明，这些模式具有更高的特异性， 与乳房X线照相术相比，并且与乳房X线照相术结合，对肿瘤具有增加的灵敏度。 然而，由于FDA批准这种用途的时间很短，使用量很小，尚未表明 使用这些方法显著降低了死亡率。纵向研究评估 乳腺癌死亡率降低功效被认为是显示这些方式的益处所必需的， 但成本高且耗时。因此，用于评估新药物的效用和益处的其他方法 这将有助于更有效地实施证明有益的技术。 尽管目前的指南没有足够的证据推荐使用新技术，马约 诊所正在实施筛查DBT和MBI在常规护理中的使用， 最有可能受益于这些方式;那些谁是乳腺癌的风险增加。马约诊所 还有一个27个县的数据共享工作，罗切斯特流行病学项目，它允许数据 所有同意EMR研究的患者的摘要。为此，本提案的目的是 描述这些模式的诊断潜力（目标1）和非死亡结局（目标2）， 通过使用阶段和重复性，开发独立于直接死亡率降低的评估方法 在诊断时，在有能力支持这项研究的环境中。这些目标的实现可能 提供一个框架和证据，以便更有效地实施新技术， 癌症检测，潜在地规避了基于纵向死亡率的研究的需要。的 参与该项目进展的跨学科合作和培训环境将支持 申请人的发展和研究经验，并将有助于推动她作为未来的临床科学家的职业生涯。