Admin Core

管理核心

• 批准号: 10701481
• 负责人: AMANDA G PAULOVICH
• 金额: $ 17.46万
• 依托单位: FRED HUTCHINSON CANCER CENTER
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-06-05 至 2028-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10701481
• 关键词: Administrator; Biological Assay; Biological Markers; Blood; Blood Tests; Breast; Breast Cancer Early Detection; Budgets; Certification; Clinical; Communication; Complement; Contracts; Development; Documentation; Early Detection Research Network; Early Diagnosis; Ensure; Environment; Grant; Human; Institutional Review Boards; Laboratories; Logistics; Malignant Neoplasms; Mammographic screening; Mammography; Manuscripts; Mass Spectrum Analysis; Methods; Mucin 1 protein; Mus; National Cancer Institute; Patient-derived xenograft models of breast cancer; Phase; Plasma; Plasma Proteins; Productivity; Progress Reports; Proteomics; Qualifying; Sampling; Site Visit; Specificity; Target Populations; Testing; Travel; United States; Universities; Washington; Woman; biobank; biomarker discovery; biomarker validation; cancer biomarkers; candidate marker; candidate validation; experience; follow-up; high risk; improved; industry partner; malignant breast neoplasm; member; multiple reaction monitoring; novel; novel marker; operation; pre-clinical; programs; protein biomarkers; screening guidelines; timeline; tumor; validation studies

Project Summary/Abstract (Administrative Core Component, RFA-CA-22-040) We propose to develop a blood-based test whose indicated use is to complement mammography in the early detection of breast cancers. Although mammography saves lives through early detection, it is imperfect. Approximately one in seven breast cancers goes undetected despite screening mammography, and interval cancers that manifest within a year of a normal mammogram remain a vexing problem, especially (although not exclusively) for the >27 million women in the United States with heterogeneously or extremely dense breasts at high risk for interval cancers. We propose to develop a blood test that could be used as an adjunct to mammography to improve early detection by improving sensitivity and/or specificity of mammography. Using a novel biomarker discovery approach leveraging human-in-mouse breast cancer patient-derived xenograft models and state-of-the-art mass spectrometry methods, we prioritized a subset of 162 candidate breast cancer protein biomarkers (verified in human plasma from breast cancer cases vs. controls) for follow up EDRN phase 2 validation studies in this proposed BCC. Our project will clinically validate and deploy (in our CLIA laboratories) a novel multiplex immuno-multiple reaction monitoring mass spectrometry (immuno-MRM-MS) assay to perform EDRN phase 2 biomarker validation studies using strongly unbiased sets of plasma samples obtained from existing biorepositories. The Administrative Core will support all aspects of the BCC, including managing all administrative and project management aspects of the BCC (e.g., budgets, contracts, timelines, IRB documentation, site visits, travel arrangements, progress reports, manuscript submission), as well as managing all center logistics and communication (e.g., coordination of all communications within the BCC, between the BCC and NCI, and between our BCC and others in the Network).

项目摘要/摘要（管理核心组件，RFA-CA-22-040） 我们建议开发一种基于血液的测试，其指定用途是在早期阶段补充乳房X光检查 乳腺癌的检测。尽管乳房X光检查可以通过早期检测挽救生命，但它并不完美。 尽管进行了乳房X光检查和间隔检查，但仍有大约七分之一的乳腺癌未被发现 正常乳房X光检查一年内出现的癌症仍然是一个令人烦恼的问题，尤其是（尽管不是 专门针对美国超过 2700 万乳房不均匀或极其致密的女性 间期癌症的高风险。我们建议开发一种血液测试，可以作为辅助 乳房X线照相术通过提高乳房X线照相术的敏感性和/或特异性来改善早期检测。 使用一种新颖的生物标志物发现方法，利用人鼠乳腺癌患者来源的生物标志物发现方法 异种移植模型和最先进的质谱方法，我们优先考虑了 162 个候选者的子集 乳腺癌蛋白质生物标志物（在乳腺癌病例与对照的人血浆中进行验证）用于随访 本提议的 BCC 中的 EDRN 第 2 期验证研究。 我们的项目将临床验证和部署（在我们的 CLIA 实验室）一种新型多重免疫多重 反应监测质谱 (immuno-MRM-MS) 检测以执行 EDRN 2 期生物标志物 使用从现有生物样本库获得的极无偏见的血浆样本组进行验证研究。 行政核心将支持 BCC 的各个方面，包括管理所有行政和项目 BCC 的管理方面（例如预算、合同、时间表、IRB 文件、实地考察、旅行 安排、进度报告、稿件提交），以及管理所有中心后勤和 通信（例如，协调 BCC 内部、BCC 与 NCI 之间的所有通信，以及 我们的 BCC 和网络中的其他人之间）。