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.

项目概要 该项目的长期目标是对诊断进行明确且充分的评估 乳腺癌筛查作为女性乳房X光检查的补充的潜在和非死亡结果 实现这一目标的目的是为调整目前的不足提供证据。 调整提供的护理并告知保险范围的评估指南，特别是在较低水平的地区 乳腺密度是乳腺发育最重要的危险因素之一。 30 个州在某些方面强制向患者报告癌症和乳腺密度信息。 在向患者提供识别风险增加的同时，应同时提供额外护理的选择。 为乳腺癌风险增加的女性开发的补充筛查措施 包括乳腺超声（US）、乳腺磁共振成像（MRI）、数字乳腺断层合成（DBT） 和分子乳腺成像 (MBI) 研究表明这些方法具有更高的特异性。 与乳房X线照相术相比，以及与乳房X线照相术结合对肿瘤的敏感性增加。 然而，由于使用量极少且 FDA 批准该用途的时间很短，因此尚未表明 使用这些方法评估死亡率已显着降低。 降低乳腺癌死亡率的功效被认为是显示这些方式的益处所必需的， 但成本高昂且耗时，因此需要其他方法来评估新颖性的效用和效益。 技术是必需的，并且将允许更有效地实施被证明有益的技术。 尽管目前的指南没有足够的证据来推荐使用新技术，梅奥 诊所正在对以下患者的常规护理中实施筛查 DBT 和 MBI 最有可能从这些方法中受益；那些乳腺癌风险较高的人。 还有一个 27 个县范围内的数据共享工作，即罗切斯特流行病学项目，该项目允许数据共享 为此，本提案的目的是收集所有同意 EMR 研究的患者。 按顺序描述这些方式的诊断潜力（目标 1）和非死亡结果（目标 2） 通过使用阶段和症状，开发一种独立于直接死亡率降低的评估方法 在有能力支持这项研究的环境中进行诊断时可能会完成这些目标。 为新技术的实用性和更有效的实施提供框架和证据 癌症检测，可能避免基于纵向死亡率研究的需要。 参与该项目进展的跨学科合作和培训环境将支持 申请人的开发和研究经验，并将有助于推动她作为未来临床科学家的职业生涯。