(EET Biobank) NCI Early-Phase and Experimental Clinical Trials Biospecimen Bank

(EET Biobank) NCI 早期和实验性临床试验生物样本库

基本信息

批准号：
10079353
负责人：
Kathleen Nicol
金额：
$ 253.24万
依托单位：
RESEARCH INST NATIONWIDE CHILDREN'S HOSP
依托单位国家：
美国
项目类别：
财政年份：
2020
资助国家：
美国
起止时间：
2020-09-01 至 2026-05-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10079353
关键词：
Breast Cancer Patient Cancer Therapy Evaluation Program Clinical Clinical Data Clinical Trials Clinical Trials Information for Patients Clinical Trials Network Collection Colon Coupled Data Development Enrollment Ensure Epidemiology Evaluation Funding Goals Guidelines Human Immunologic Monitoring Information Systems Infrastructure Investigational Therapies Link Lung Lymphoma Malignant Neoplasms Marketing Medidata Multiple Myeloma National Cancer Institute Oncology Operative Surgical Procedures Outcome Pathologic Patients Pediatric Hospitals Pediatric Oncology Group Pharmaceutical Preparations Phase Policies Procedures Process Prostate Quality Control Radiology Specialty Recording of previous events Reporting Research Research Design Research Institute Research Personnel Resources Sampling Southwest Oncology Group Standardization Technology Therapeutic Agents Work anti-cancer therapeutic anticancer research base biobank cancer prevention cancer recurrence cancer type early phase clinical trial experience improved improved outcome laboratory equipment leukemia melanoma operation targeted treatment therapy outcome tumor working group

项目摘要

Project Summary The Biopathology Center (BPC), part of the Abigail Wexner Research Institute of Nationwide Children’s Hospital, houses the Experimental Therapeutics Clinical Trials Network (ETCTN) Biospecimen Bank (Biobank). In this project, the ETCTN Biobank will expand to include other National Cancer Institute (NCI)-supported early-phase and experimental trial networks and investigators and be known as the Early-Phase and Experimental Clinical Trials (EET) Biobank. The NCI supports a clinical trials infrastructure to facilitate the early stages of development and evaluation of anti-cancer therapeutic agents. The EET Biobank will promote a collection of standardized biospecimens by procuring, processing, banking, and distributing high-quality human biospecimens from cancer patients who participate in NCI Phases 0, I, and II trials and other experimental therapeutic cancer trials. EET clinical trials will include a range of cancer types (i.e., breast, lung, colon, prostate, leukemia, melanoma, lymphoma, and multiple myeloma). These biospecimens will be linked to detailed biospecimen-related data (including information on surgical, pathological, and radiological reports), as well as comprehensive clinical data, including detailed drug information, treatment histories/outcomes, and cancer recurrence data. The EET Biobank will work closely with study teams and investigators to ensure that biospecimens are handled appropriately for planned and future research. In these efforts, the EET Biobank will continue to support the processing, banking, and distribution of biospecimens to the Cancer Immune Monitoring and Analysis Centers (CIMACs). Biospecimens will first be distributed to investigators for planned research designed to meet the objectives included in the clinical trial. After the objectives in the clinical trial are met, the EET Biobank will then distribute biospecimens to qualified investigators for projects approved by the Cancer Therapy Evaluation Program (CTEP). The EET Biobank seeks to promote outstanding research through the banking of high-quality, clinically annotated, cancer-related human biospecimens. To support this effort, the EET Biobank will manage these biospecimens under strict guidelines and standard operating procedures based on current best practices for biorepositories, current regulatory guidelines, and the latest laboratory technologies. The EET Biobank will benefit from the BPC’s experience in supporting biobanking efforts for several NCI-funded groups, including the NCTN (Children’s Oncology Group [COG], SWOG [formerly the Southwest Oncology Group], NRG Oncology) and the ETCTN. Coupled with a firm commitment to quality and to the integrity of its operations, the EET Biobank will be uniquely able to provide an accurate and effective resource of high-quality tumor and normal samples with associated clinical and epidemiologic information.

项目概要生物病理学中心 (BPC)，隶属于全国儿童阿比盖尔韦克斯纳研究所医院设有实验治疗临床试验网络 (ETCTN) 生物样本库 (Biobank)。在该项目中，ETCTN 生物库将扩展到包括其他国家癌症研究所 (NCI) 支持的项目早期和实验性试验网络和研究人员，被称为早期和实验性试验网络和研究人员实验性临床试验 (EET) 生物库 NCI 支持临床试验基础设施，以促进早期试验。 EET 生物库将促进抗癌治疗药物的开发和评估阶段。通过采购、加工、储存和分配高质量的人类样本来收集标准化生物样本来自参加 NCI 0、I 和 II 期试验以及其他实验的癌症患者的生物样本治疗性癌症试验。 EET 临床试验将包括一系列癌症类型（即乳腺癌、肺癌、结肠癌、前列腺癌、白血病、黑色素瘤、淋巴瘤和多发性骨髓瘤）。这些生物样本将与详细的生物样本相关数据相关联。（包括手术、病理和放射学报告信息）以及临床综合报告数据，包括详细的药物信息、治疗历史/结果和癌症复发数据。生物样本库将与研究团队和研究人员密切合作，确保生物样本得到处理在这些努力中，EET 生物银行将继续支持生物样本的处理、储存和分发到癌症免疫监测和分析中心（CIMAC）将首先分发给研究人员进行旨在满足的计划研究。临床试验目标实现后，EET Biobank 将进行临床试验。向癌症治疗评估批准的项目的合格研究人员分发生物样本计划（CTEP）。 EET 生物银行致力于通过存储高质量的临床研究来促进杰出的研究为了支持这项工作，EET 生物库将管理这些带注释的癌症相关人类生物样本。生物样本遵循基于当前最佳实践的严格指导方针和标准操作程序 EET 生物库将提供生物样本库、现行监管指南和最新的实验室技术。受益于 BPC 在支持多个 NCI 资助团体的生物样本库工作方面的经验，包括 NCTN（儿童肿瘤学组 [COG]、SWOG [前西南肿瘤学组]、NRG 加上对质量和运营诚信的坚定承诺， EET Biobank 将具有独特的能力，提供准确、有效的高质量肿瘤和疾病资源。具有相关临床和流行病学信息的正常样本。