Early Detection Resrearch Network - Biomarker Reference Laboratory

早期检测研究网络 - 生物标志物参考实验室

• 批准号: 8559488
• 金额: $ 59.93万
• 依托单位: NATIONAL CANCER INSTITUTE
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/8559488
• 关键词: Accountability; Agreement; Amendment; Animals; Award; Biological; Biological Assay; Biological Markers; Cancer Detection; Cells; Collaborations; Communication; Consent Forms; Consultations; Contracts; Cytolysis; DNA; DNA Damage; Data; Development; Disease; Early Detection Research Network; Early Diagnosis; Educational workshop; Ensure; Evaluation; Funding; Future; Gene Expression Profile; Goals; Government; Human; Image; Image Analysis; Imaging Techniques; Individual; Institutional Review Boards; Joints; Laboratories; Lesion; Liquid substance; Malignant Neoplasms; Manuscripts; Measurement; Measures; Methods; MicroRNAs; Microfluidics; Molecular Analysis; Nanotechnology; Performance; Physicians; Policies; Private Practice; Procedures; Proteins; Protocols documentation; Publications; Quality Control; Research; Research Design; Research Infrastructure; Research Personnel; Research Support; Rights; Risk; Risk Assessment; Sampling; Site; Source; Specimen; Standardization; System; Titrations; United States National Institutes of Health; Urine; Validation; Variant; Whole Blood; Work; Writing; assay development; base; cancer risk; cancer stem cell; cost; data management; design; material transfer agreement; meetings; member; metrology; neoplastic cell; research study; symposium; urinary

Task 1: Validation of cancer biomarkers, analytical validation of biomarker assays, and development of biomarker assays. During the term of this IAA, cancer biomarkers and/or assay methods developed by EDRN investigators will need validation by the BRL at NIST. The NCI Contracting Officer Technical Representative, after consultation with the EDRN Steering Committee, will provide NIST with a written description of the work to be performed. NIST will then provide an experimental plan that includes assay methods, source of samples/specimens, evaluation criteria, staff involved, proposed milestones, and estimated costs. The proposed protocols must be acceptable to NCI, NIST and, if applicable, the initiating EDRN investigator. The acceptance of these projects by NIST is contingent upon availability of NIST staff, their expertise, facilities, and funds provided by this IAA. It is anticipated that NIST will initially undertake the three projects described in Tasks 2. During the term of this IAA, the NCI Contracting Officer Technical Representative may assign other projects to the NIST BRL that are of higher priority than those described in Task 2. This may require NIST to reassign staff from the projects described in Task 2. Task 2: Biomarker and assay developmental projects a) Urine as the noninvasive biological fluid for cancer biomarker The Agency shall develop methods to isolate and quantitatively measure of DNA cancer biomarkers in urine for non-urinary track cancers and/or validate specific DNA biomarkers in urine for either a urinary or non-urinary track cancers. b) Capture and molecular analysis of single circulating tumor cells (CTCs) The Agency shall use a microfluidic platform to isolate CTCs from whole blood, obtain phenotypic information using advanced imaging techniques, measure microRNA and protein release from single captured CTCs, measure single cell transcriptome and protein content following cell lysis, combine information from imaging and molecular analysis to produce signature from the cell and correlate cell signatures with disease type. c) MicroRNA measurements The Agency shall determine the performance of microRNA assays (within platform, and amongst platforms), using a multiple-animal titration-based experiment design, to assess technical performance, identify sources of variation, and compare results across labs and platforms. Future possible projects may include but are not limited to nanotechnologies for cancer detection, DNA damage/lesions as biomarkers for cancer risk assessment and early detection, and imaging metrology for cancer stem cells Task 3: Provide support to the NCI Contracting Officer Technical Representative in preparing programmatic relevant manuscripts for publication that derive in part or entirely from work performed under the agreement. The support shall include technical descriptions of and references for all the applied assay procedures. Task 4: Provide guidance to other EDRN investigators regarding assays standardization, optimization, and quality control. Task 5: Manage individual protocols or research and collaborative projects approved by the NCI Contracting Officer Technical Representative. Task 6: Verify that participating sites have all relevant human risk assurance documents, as required, on file with the Office for Protection from Risk (OPRR), NIH. Physicians in private practice must have an approved Non-institutional Investigator Agreement (NIA) on file with the Center. Task 7: Ensure that all projects involving human specimens are approved by the NIST IRB and that Material Transfer Agreements are approved by NIST officials. Task 8: Assume responsibility and accountability to NIST officials and to the NCI for the performance and proper conduct of the research supported by the IAA in accordance with the terms and conditions of the award. Task 9: Serve as a nonvoting member of the Steering Committee, participate in planning workshops and symposia, and have two senior staff members attend two Steering Committee meetings and one EDRN workshop or symposia per year. Task 10: Collaborate with NCI to ensure that NCI is a joint-owner with NIST of rights to the data developed under this award, and that NCI and NIST may freely use the data, subject to Government rights of access consistent with current NIST, HHS, PHS, and NIH policies. Task 11: Implement the goals, priorities, common protocols, procedures, and policies agreed upon by the Steering Committee for the Network collaborative studies. Task 12: Ensure EDRN and NCI review and approval of protocol, concepts, final protocol documents, informed consents, and study amendments, and advise NCI of changes in protocol status. Task 13: Collaborate on common research designs or protocols, including methods and requirements for joint participation and collaboration as recommended by the Steering Committee, and handling of data, including appropriate sharing of methods and data among collaborating organizations, and propose strategies for communication among themselves, with the other Network components, and with the NCI. Task 14: Adapt data management system so that it is compatible with EDRN data infrastructures.

任务1：癌症生物标志物的验证，生物标志物测定的分析验证，以及生物标志物测定的开发。在IAA期间，EDRN研究人员开发的癌症生物标志物和/或检测方法将需要NIST BRL的验证。NCI合同官员技术代表在与EDRN指导委员会协商后，将向NIST提供将要执行的工作的书面描述。然后，NIST将提供一个实验计划，包括分析方法、样品/标本来源、评估标准、涉及的工作人员、提议的里程碑和估计的成本。提议的方案必须被NCI， NIST和（如果适用的话）发起EDRN研究者所接受。NIST对这些项目的接受取决于NIST工作人员的可用性、他们的专业知识、设施和IAA提供的资金。预计NIST将首先承担任务2中描述的三个项目。在本IAA期限内，NCI合同官员技术代表可以向NIST BRL分配比任务2中描述的优先级更高的其他项目。这可能需要NIST从任务2中描述的项目中重新分配人员。a)尿液作为癌症生物标志物的非侵入性生物液体原子能机构应开发方法，分离和定量测量非尿路癌尿液中的DNA癌症生物标志物和/或验证尿路癌或非尿路癌尿液中的特定DNA生物标志物。b)单个循环肿瘤细胞（CTCs）的捕获和分子分析：该机构应使用微流控平台从全血中分离CTCs，使用先进的成像技术获得表型信息，测量单个捕获的CTCs的microRNA和蛋白质释放，测量细胞裂解后的单细胞转录组和蛋白质含量，结合成像和分子分析的信息产生细胞特征，并将细胞特征与疾病类型相关联。c) MicroRNA测量fda应使用基于多动物滴定的实验设计，确定MicroRNA测定的性能（平台内和平台之间），以评估技术性能，确定变异来源，并比较实验室和平台之间的结果。未来可能的项目可能包括但不限于用于癌症检测的纳米技术，作为癌症风险评估和早期检测的生物标志物的DNA损伤/病变，以及癌症干细胞的成像计量。任务3：为NCI合同官员技术代表提供支持，以准备部分或全部来自协议项下工作的程序性相关手稿。支持文件应包括所有应用分析程序的技术说明和参考资料。任务4：为其他EDRN研究人员提供有关检测标准化、优化和质量控制的指导。任务5：管理由NCI合同官员技术代表批准的个人协议或研究和合作项目。任务6：验证参与站点是否有所有相关的人类风险保证文件，并按要求在NIH风险保护办公室（OPRR）存档。私人执业的医生必须有一份经批准的非机构调查员协议（NIA）在中心存档。任务7：确保所有涉及人类标本的项目都得到NIST IRB的批准，并且材料转移协议得到NIST官员的批准。任务8：根据奖项的条款和条件，为IAA支持的研究的表现和适当的行为向NIST官员和NCI承担责任和责任。任务9：作为指导委员会的非投票成员，参加计划研讨会和专题讨论会，每年有两名高级工作人员参加两次指导委员会会议和一次EDRN研讨会或专题讨论会。任务10：与NCI合作，确保NCI与NIST共同拥有根据本奖项开发的数据的权利，并且NCI和NIST可以自由使用这些数据，但须遵守与当前NIST、HHS、PHS和NIH政策一致的政府访问权。任务11：实施网络合作研究指导委员会商定的目标、优先事项、共同协议、程序和政策。任务12：确保EDRN和NCI审查和批准方案、概念、最终方案文件、知情同意和研究修订，并向NCI通知方案状态的变化。任务13：在共同的研究设计或协议上进行合作，包括指导委员会建议的联合参与和合作的方法和要求，以及数据的处理，包括在合作组织之间适当地共享方法和数据，并提出彼此之间、与其他网络组件以及与NCI的通信策略。任务14：调整数据管理系统，使其与EDRN数据基础设施兼容。