Administrative Core-Biomarkers for optimizing risk prediction and early detection of cancers of the colon and esophagus

用于优化结肠癌和食道癌风险预测和早期检测的管理核心生物标志物

• 批准号: 10677826
• 负责人: William Mallory Grady
• 金额: $ 41.74万
• 依托单位: FRED HUTCHINSON CANCER CENTER
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-08-05 至 2027-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10677826
• 关键词: Administrative Coordination; Administrator; Biological Assay; Biological Markers; CLIA certified; Cancer Intervention and Surveillance Modeling Network; Clinical; Collaborations; Communication; Data; Data Analyses; Data Commons; Data Coordinating Center; Development; Early Detection Research Network; Early Diagnosis; Education; Environment; Funding; Funding Agency; Future; Industrialization; Institution; Letters; Malignant neoplasm of esophagus; Malignant neoplasm of gastrointestinal tract; Mission; Process; Productivity; Rana; Research; Research Personnel; Running; Scientist; Screening for cancer; Structure; System; Teleconferences; United States National Institutes of Health; Validation; Work; biomarker discovery; biomarker validation; clinical biomarkers; clinical development; colon cancer screening; data dissemination; data sharing; data submission; industry partner; innovation; interest; meetings; member; operation; organizational structure; programs; protocol development; risk prediction; success; validation studies

PROJECT SUMMARY The Administrative Core (AC) of our Biomarker Characterization Center (BCC) will facilitate and optimize the integration of biomarker discovery and initial validation studies by the Biomarker Discovery Lab (BDL) and the development and validation studies to create clinical-grade, CLIA compliant biomarker assays by the Biomarker Reference Lab (BRL). The Administrative Core will be managed by the Center Administrator and run by the PIs of the BDL and BRL. It will support and enhance cross BCC and cross EDRN communication, data dissemination and data review and analysis, which will promote the BCC’s core mission to discovery and validate clinical grade biomarker assays for GI cancer risk prediction and early detection The Administrative Core will provide administrative support for collaborations and communications between the EDRN BCCs, Clinical Validation Centers (CVCs), Data Management Center (DMCC); collaborating industrial partners (e.g. Cernostics, Qiagen, etc.) and academic partners, and collaborating NCI programs (e.g. CISNET, NIST, etc.). Through the functions of the Administrative Core, the BCC with other EDRN BCCs, CVC, and DMCC, industrial partners, and academic partners will collaborate not only on the BCC’s studies but also on resulting derivative studies and other EDRN BCC and CVC projects that arise from the BCC’s highly innovative, productive and significant program of biomarker discovery and validation for GI cancer risk prediction and early detection and the programs of other BCCs. The Administrative Core has the following aims: Aim 1: To provide the organizational structure for supporting the key objectives of the BCC, which are the BDL’s and BRL’s scientific and educational missions and the successful collaboration among the BDL and BRL PI and scientists, EDRN partners, academic partners and industrial partners. Aim 2: To provide efficiency in management of large-scale collaborative research efforts involving multiple institutions and multiple PDs/PIs, including local and national meetings management. Aim 3: To coordinate with EDRN DMCC for protocol development, biospecimen sharing, biospecimen blinding, data analysis, data sharing, data deposition, populating Biomarker Data Commons, and any other relevant functions deemed necessary for BCC operations as well as for the larger Network.

项目概要 我们的生物标志物表征中心 (BCC) 的管理核心 (AC) 将促进和优化 生物标志物发现实验室 (BDL) 整合生物标志物发现和初步验证研究，以及 开发和验证研究，以创建临床级、符合 CLIA 标准的生物标志物测定 生物标记参考实验室 (BRL)。管理核心将由中心管理员管理并运行 由 BDL 和 BRL 的 PI 执行。它将支持和增强跨 BCC 和跨 EDRN 通信、数据 传播以及数据审查和分析，这将促进 BCC 发现和验证的核心使命 用于胃肠道癌症风险预测和早期检测的临床级生物标志物测定 管理核心将 为 EDRN BCC、临床 验证中心 (CVC)、数据管理中心 (DMCC)；工业合作伙伴（例如 Cernostics、 Qiagen 等）和学术合作伙伴，以及 NCI 合作项目（例如 CISNET、NIST 等）。通过 行政核心、BCC 与其他 EDRN BCC、CVC 和 DMCC、行业合作伙伴的职能，以及 学术合作伙伴不仅将在 BCC 的研究上进行合作，还将在由此产生的衍生研究和 其他 EDRN BCC 和 CVC 项目源于 BCC 的高度创新、高效和重要 胃肠道癌症风险预测和早期检测的生物标志物发现和验证计划以及该计划 其他 BCC。 行政核心的目标如下： 目标 1：提供支持 BCC 关键目标（即 BDL 的目标）的组织结构 和 BRL 的科学和教育使命以及 BDL 和 BRL PI 之间的成功合作 科学家、EDRN 合作伙伴、学术合作伙伴和工业合作伙伴。 目标 2：提高涉及多个领域的大规模合作研究工作的管理效率 机构和多个 PD/PI，包括地方和国家会议管理。 目标 3：与 EDRN DMCC 协调方案开发、生物样本共享、生物样本盲法、 数据分析、数据共享、数据存储、填充生物标记数据共享以及任何其他相关 BCC 操作以及更大的网络所必需的功能。