NRG Oncology Biospecimen Bank

NRG 肿瘤生物样本库

• 批准号: 10379380
• 负责人: RICHARD C JORDAN
• 金额: $ 422.98万
• 依托单位: NRG ONCOLOGY FOUNDATION, INC.
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-04-22 至 2026-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10379380
• 关键词: Address; Adopted; Adult; Bioinformatics; Biological Markers; Biological Specimen Banks; Brain; Breast; Cancer Patient; Catalogs; Chest; Clinical; Clinical Research; Clinical Treatment; Clinical Trials; Clinical Trials Network; Collaborations; Collection; Communication; Communities; Community Clinical Oncology Program; Data; Disease; Enrollment; Epidemiology; Equipment and supply inventories; Feedback; Foundations; Freezing; Funding; Future; Gender; Genomics; Goals; Gynecologic Oncology Group; Head and neck structure; Health; Influentials; Informatics; Information Systems; Infrastructure; Jordan; Knowledge; Laboratories; Link; Liquid substance; Lung; Malignant Neoplasms; Methods; National Cancer Institute; National Clinical Trials Network; National Surgical Adjuvant Breast and Bowel Project; Non-Hematologic Malignancy; Normal tissue morphology; Oncology; Patients; Performance; Phase; Positioning Attribute; Prediction of Response to Therapy; Process; Prognosis; Protocols documentation; Publications; Radiation Therapy Oncology Group; Reporting; Research; Research Personnel; Sampling; Science; Secure; Services; Site; Specimen; Standardization; System; Tissues; Translational Research; Treatment outcome; Tumor Markers; Tumor Tissue; United States National Institutes of Health; Work; advanced disease; arm; biobank; cancer care; cancer clinical trial; cancer therapy; cohort; data exchange; digital imaging; experience; improved; innovation; interest; interoperability; member; oncology trial; operation; patient population; performance site; personalized approach; preservation; quality assurance; repository; sample collection; targeted therapy trials; translational scientist; translational study; treatment trial; tumor

Project summary: NRG Oncology (hereafter NRG), a member of the NCI-supported National Clinical Trials Network (NCTN), was created in 2014 through the merger of the National Surgical Adjuvant Breast and Bowel Project (NSABP), the Radiation Therapy Oncology Group (RTOG), and the Gynecologic Oncology Group (GOG). These three National Cancer Institute (NCI)-supported legacy cancer cooperative groups had over 150 years cumulative experience in the conduct of practice-defining, multi-institutional, Phase II and III practice changing clinical cancer trials. Since its inception, NRG has made significant progress toward its goal of improving the duration and quality of lives of adults with specific non-hematologic malignancies through the conduct of its clinical research. Its specifically defined patient populations of interest, those with gender- specific malignancies, and/or those with localized or locally advanced disease, are unique within the NCTN, constituting a large and relatively under-investigated cohort of cancer patients. Underpinning these activities has been the NRG Oncology Biospecimen Bank (hereafter NRG-BB) that has since 2015 received, processed, annotated and stored 259,415 biospecimens from over 14,356 patients enrolled on 103 phase I, II and III adult NCTN and NCORP trials. These biospecimens have been used for integral, integrated, and exploratory translational science to answer a range of key questions in cancer directly leading to 82 highly influential and practice changing publications. NRG Oncology plans to enroll up to 3,183 patients per year in future NCI-funded NRG and NCORP sponsored cancer clinical trials. For use in trial-related activities and future translational science projects the NRG-BB will collect, process and manage biospecimens from patients enrolled in Phase II & III clinical treatment trials to maintain an accurate and effective repository of tumor and normal tissues with associated clinical, epidemiologic, and descriptive biospecimen information. The NRG-BB will maximize the quality and quantity of biospecimens and their derivatives through the utilization of standardized and optimal preservation, storage, quality assurance and distribution methods. We will market and distribute de-identified samples in a standardized and equitable manner to all qualified investigators both within and outside NRG Oncology by continue to work closely with the NCTN Navigator and "front door" services. Working with the biobanks from other NCTN groups and the Group Banking Committee of the NCI, we will continue to harmonize biospecimen activities and processes. Finally, we will capitalize on our distributed infrastructure to support and/or perform innovative genomic analyses for patient assignment to multi-arm targeted therapy trials conducted by NRG Oncology. Robust informatics is required to allow translational scientists to know what is available within the NRG-BB and to equitably distribute biospecimens to the translational science community both within and outside NRG Oncology. We have implemented a robust and integrated specimen Tracking and Reporting System (STARS) bioinformatics platform across our three NRG-BB performance sites. This common IT platform across the 3 biospecimen bank sites has permitted an improved service level for the group, interoperability and freely exchangeable data with our NRG-BB partners and opportunities to enhance our links with the SDMC. Moreover, this new platform has permitted better external linkages with the Group Banking Committee, the NCI and with the Navigator and Front Door project. Relevance: The collection, management and distribution of high quality and well annotated biospecimens associated with NRG clinical trials data will lead to translational studies for validating biomarkers of tumor prognosis and prediction of response to therapy, ultimately leading to improved treatment of cancer patients. These activities will support improved quality of biospecimens, and expanded access for translational scientists, thus leading to better quality research and identifying appropriate patients for personalized approaches to improved cancer care.

项目概要： NRG肿瘤学（以下简称NRG），NCI支持的国家临床试验网络（NCTN）的成员， 2014年，国家外科辅助乳腺和肠道项目（National Surgical Adjuvant Breast and Bowel Project） （NSABP），放射治疗肿瘤组（RTOG）和妇科肿瘤组（GOG）。 这三个国家癌症研究所（NCI）支持的传统癌症合作小组有超过150个 在实践定义、多机构、第二阶段和第三阶段实践方面积累了多年的经验 改变癌症临床试验自成立以来，NRG在实现其目标方面取得了重大进展， 通过以下方式改善患有特定非血液系统恶性肿瘤的成人的生存时间和生活质量： 进行临床研究。其具体定义的感兴趣的患者人群，那些有性别- 特定的恶性肿瘤和/或具有局部或局部晚期疾病的那些，在NCTN中是独特的， 构成了一个大的且相对未被充分研究的癌症患者群体。这些活动的基础 自2015年以来，NRG肿瘤生物样本库（以下简称NRG-BB）已收到， 处理、注释并储存了来自103期入组的14，356名患者的259，415份生物标本 I、II和III成人NCTN和NCORP试验。这些生物标本已被用于整体，综合， 和探索性转化科学，以回答癌症的一系列关键问题，直接导致82 具有很强的影响力和实践不断变化的出版物。NRG Oncology计划招募多达3，183名患者， 在未来的NCI资助的NRG和NCORP赞助的癌症临床试验中，用于试验相关 活动和未来的转化科学项目，NRG-BB将收集，处理和管理 从参加II期和III期临床治疗试验的患者中采集生物样本，以保持准确和 肿瘤和正常组织的有效储存库，以及相关的临床、流行病学和描述性 生物标本信息。NRG-BB将最大限度地提高生物标本的质量和数量， 通过利用标准化和最佳的保存、储存、质量保证和 分配方法我们将以标准化和公平的方式营销和分发去识别样品 NRG肿瘤科内外的所有合格研究者继续与 NCTN导航器和“前门”服务。与其他NCTN小组的生物库和 NCI集团银行委员会，我们将继续协调生物标本活动和流程。 最后，我们将利用我们的分布式基础设施来支持和/或执行创新的基因组 NRG Oncology进行的多组靶向治疗试验的患者分配分析。鲁棒 信息学是必要的，以使翻译科学家知道什么是可利用的NRG-BB和 将生物标本公平地分配给NRG内外的转化科学界 肿瘤科我们已经实施了一个强大的和综合的标本跟踪和报告系统 （STARS）的生物信息学平台，在我们的三个NRG-BB性能网站。这个通用的IT平台 在3个生物样本库站点之间， 和自由交换数据与我们的NRG-BB合作伙伴和机会，以加强我们的联系， SDMC。此外，这一新平台还能加强与集团银行业务的外部联系 委员会，NCI和导航仪和前门项目。 相关性： 收集、管理和分发高质量和注释良好的生物标本， NRG临床试验数据将导致转化研究，用于验证肿瘤预后的生物标志物 以及对治疗反应的预测，最终导致癌症患者治疗的改善。这些 这些活动将支持提高生物标本的质量，扩大转化科学家的获取， 从而导致更高质量的研究，并为个性化方法确定合适的患者， 改善癌症护理。