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（行政核心组件，RFA-CA-22-040） 我们建议开发基于血液的测试，其指示的用途是早期乳房X线摄影 检测乳腺癌。尽管乳房X线摄影通过早期发现可以挽救生命，但这是不完美的。 尽管进行了乳房X线摄影和间隔 在正常乳房X线照片后一年内表现出的癌症仍然是一个烦人的问题，尤其是 独家）对于美国的2700万妇女，乳房异质性或非常密集的乳房 间隔癌的高风险。我们建议开发一种可以用作辅助的血液检查 通过提高乳房X线摄影的敏感性和/或特异性来改善乳房X线摄影以改善早期检测。 使用一种新型的生物标志物发现方法利用人类室内乳腺癌患者衍生 异种移植模型和最先进的质谱法，我们优先考虑162个候选者 乳腺癌蛋白生物标志物（乳腺癌病例与对照组中的人血浆验证）可随访 EDRN第2阶段验证研究中的该拟议的BCC。 我们的项目将在临床上验证和部署（在我们的CLIA实验室）一个新颖的多重免疫媒体。 反应监测质谱法（Immuno-MRM-MS）测定以执行EDRN阶段2生物标志物 使用从现有的生物塑料中获得的强烈无偏血浆样品集的验证研究。 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，现场访问，旅行 安排，进度报告，手稿提交）以及管理所有中心物流和 沟通（例如，BCC，BCC和NCI之间的所有通信协调 在我们的BCC和网络中的其他人之间）。