(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

• 批准号: 10642821
• 负责人: Kathleen Nicol
• 金额: $ 246.76万
• 依托单位: RESEARCH INST NATIONWIDE CHILDREN'S HOSP
• 依托单位国家: 美国
• 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/10642821
• 关键词: Biological Specimen Banks; 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; 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; Qualifying; Quality Control; Radiology Specialty; Recording of previous events; Recurrent Malignant Neoplasm; Reporting; Research; Research Design; Research Institute; Research Personnel; Resources; Sampling; Southwest Oncology Group; Standardization; Technology; Therapeutic Agents; Work; anti-cancer therapeutic; anticancer research; biobank; cancer prevention; cancer recurrence; cancer type; data management; early phase clinical trial; experience; improved; improved outcome; laboratory equipment; leukemia; melanoma; operation; participant enrollment; targeted treatment; therapy outcome; tumor; working group

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.

项目摘要 生物病理学中心（BPC），阿比盖尔韦克斯纳研究所的一部分，全国儿童的 实验治疗药物临床试验网络（ETCTN）生物样本库（Biobank）。 在这个项目中，ETCTN生物库将扩大到包括其他国家癌症研究所（NCI）支持的 早期阶段和实验性试验网络和研究人员，被称为早期阶段和 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 抗癌治疗剂的开发和评价阶段。EET生物银行将促进 通过采购、加工、储存和分发高质量的人类样本，收集标准化的生物标本。 来自参与NCI 0期、I期和II期试验以及其他实验性研究的癌症患者的生物样本 癌症治疗试验 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、病理和放射学报告的信息），以及全面的临床 数据，包括详细的药物信息，治疗历史/结果和癌症复发数据。EET 生物样本库将与研究团队和研究者密切合作，以确保生物样本的处理 适合计划和未来的研究。在这些努力中，EET生物库将继续支持 处理、储存和分发生物样本至癌症免疫监测和分析中心 （CIMAC）。生物标本将首先分发给研究者，用于计划的研究，以满足 纳入临床试验的目的。在达到临床试验的目标后，EET生物样本库将 将生物样本分发给合格的研究者，用于癌症治疗评估批准的项目 计划（CTEP）。 EET生物库旨在通过高质量的、临床的、 带注释的癌症相关人体生物标本。为了支持这一努力，EET生物库将管理这些 生物标本的严格指导方针和标准操作程序，基于当前的最佳做法， 生物储存库、现行法规指南和最新的实验室技术。EET生物银行将 受益于BPC在支持几个NCI资助团体的生物库工作方面的经验，包括 NCTN（儿童肿瘤组[COG]，SWOG [原西南肿瘤组]，NRG 肿瘤学）和ETCTN。加上对质量和运营诚信的坚定承诺， EET生物库将能够提供准确有效的高质量肿瘤资源， 具有相关临床和流行病学信息的正常样本。