Molecular Characterization Trial

分子表征试验

• 批准号: 10712292
• 负责人: David Kozono
• 金额: $ 32.51万
• 依托单位: DANA-FARBER CANCER INST
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-19 至 2028-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10712292
• 关键词: Acceleration; Adult; Aftercare; Amendment; Appearance; Artificial Intelligence; Autopsy; Biological Assay; Biopsy; Blood; Blood specimen; California; Cancer Biology; Cancer Center; Caregivers; Characteristics; Child; Childhood; Clinical; Clinical Data; Clinical Research; Clinical Trials; Collaborations; Collection; Communities; Consent; Data; Data Collection; Data Element; Data Science; Data Storage and Retrieval; Ensure; Goals; Hand; Health protection; Heterogeneity; Image; Institution; Investigation; Knowledge; Late Effects; Lead; Long-Term Survivors; Malignant Childhood Neoplasm; Malignant Neoplasms; Molecular; Mutation; National Clinical Trials Network; Neuroblastoma; Oncology; Operative Surgical Procedures; Parents; Patients; Pediatric Oncology Group; Performance; Pilot Projects; Procedures; Protocols documentation; Radiation; Radiation Oncology; Radiation exposure; Radiation therapy; Radiopharmaceuticals; Recurrence; Reproducibility; Research; Research Project Grants; Resource Sharing; Resources; Sampling; San Francisco; Signal Transduction; Site; Solid Neoplasm; Source; Standardization; Testing; The Cancer Genome Atlas; Therapeutic Trials; Tissues; Universities; Work; age group; biobank; clinical trial protocol; cohort; data resource; design; diffuse midline glioma; dosimetry; embryo tissue; high risk; immune-related adverse events; innovation; metaiodobenzylguanidine; multidimensional data; multimodality; neoplastic cell; neuro-oncology; novel; pediatric patients; programs; radiation response; risk minimization; sample collection; standard of care; structured data; success; tumor; validation studies

PROJECT SUMMARY The Molecular Characterization Trial (MCT) is the source of biospecimen and data resources for the ROBIN Center. As such, its success is paramount to the success of the entire initiative, and strategies that expedite the acquisition of these essential resources will accelerate the timeframe in which they are made available for all the innovative work performed in the Research Projects and Cores. The Harvard/UCSF ROBIN has chosen for its theme the study of pediatric malignancies as the optimal setting for in depth investigation into the impact of heterogeneity, in both its tumor cell intrinsic and extrinsic manifestations, on radiation responses. The MCT will achieve these goals via the following Aims: Aim 1: Coordinate the collection of biospecimens and clinical data from cooperative group studies for use in ROBIN studies. The MCT will leverage two ongoing trials: Pacific Pediatric Neuro-Oncology Consortium PNOC023 for diffuse midline glioma (DMG), and Children’s Oncology Group (COG) ANBL1531 for neuroblastoma (NBL). The study chairs for each trial are co- leads of the MCT and Project 2, respectively. As a novel feature of the MCT, matched pairs of tumor samples will be available from subjects who underwent pre-treatment biopsies and subsequently had post-treatment surgical (NBL) or post-mortem (DMG) tissues obtained via established protocols. The ROBIN investigators will also leverage additional resources that are uniquely available to them, including a collection of thirty DMG tumor samples that are distinct from those obtained on the PNOC023 study and already in hand. The MCT will also bolster an aim on late effects by obtaining blood samples and clinical data from the COG Late Effects after High-Risk Neuroblastoma (LEAHRN) study, which includes 24 long-term survivors previously treated with the radiopharmaceutical 131I-MIBG. Aim 2: Manage the regulatory aspects of the MCT, including site protocols for collection of protected health information (PHI) and biospecimens in institutional biorepositories. Clinical research and data coordinators will work with site leads at both Dana-Farber/Harvard Cancer Center and UCSF to ensure rigorous and timely submission of study protocols, amendments, and continuing reviews so that the work can steadfastly proceed. Also, because all PHI will flow through the MCT, which provides de- identified resources to other ROBIN components, this will minimize risks to subject confidentiality. Aim 3: Maintain standard operating procedures for processing and analyzing tumor, blood and CSF samples and storing incoming and resultant high-dimensional data. Given the vast amounts of data involved, and the intricate assays being performed, it is essential that the work is performed in a harmonized way to maintain rigor and reproducibility. The MCT will rely on the combined expertise within the Clinical Artificial Intelligence and Imaging Core and the Molecular Data Science and Advanced Dosimetry Core to ensure compliance with de-identification and data storage standards so that the rich resources generated by the ROBIN can be used effectively by the broader research community in pilot projects and beyond.

项目总结 分子特征试验(MCT)是知更鸟的生物量来源和数据来源 中心。因此，它的成功对整个倡议的成功至关重要，并加快了 获得这些基本资源将加快提供这些资源的时间 在研究项目和核心中开展的所有创新工作。哈佛大学/加州大学旧金山分校的罗宾选择了 以儿科恶性肿瘤研究为主题，作为深入调查影响的最佳环境 在肿瘤细胞的内在和外在表现上，对辐射反应的异质性。MCT 将通过以下目标实现这些目标：目标1：协调收集生物杀虫剂和 来自合作小组研究的临床数据用于Robin研究。MCT将利用正在进行的两个 试验：太平洋儿科神经肿瘤学联盟PNOC023治疗弥漫性中线胶质瘤(DMG)，以及 儿童肿瘤学小组(COG)ANBL1531治疗神经母细胞瘤(NBL)。每项试验的研究座椅都是联合 分别是MCT和Project 2的领导。作为MCT的一个新特征，匹配的肿瘤样本对 将从接受治疗前活组织检查和随后接受治疗后的受试者获得 手术(NBL)或死后(DMG)组织通过既定的方案获得。罗宾调查人员将 还可以利用他们唯一可用的其他资源，包括30个DMG的集合 与在PNOC023研究中获得的并已在手中的那些不同的肿瘤样本。MCT将 还通过从COG晚期效应中获取血液样本和临床数据来支持关于晚期效应的目标 高危神经母细胞瘤(LEAHRN)研究，包括24名曾接受过 放射性药物131I-MIBG。目标2：管理MCT的监管方面，包括现场协议 用于收集机构生物储存库中的受保护健康信息(PHI)和生物检疫。临床 研究和数据协调员将与Dana-Farber/哈佛癌症中心和 加州大学旧金山分校确保严格和及时地提交研究方案、修正案和持续审查，以便 这项工作能够坚定不移地进行下去。此外，因为所有PHI都将流经MCT，这提供了去- 将已确定的资源分配给其他Robin组件，这将最大限度地减少保密风险。目标3： 维持处理和分析肿瘤、血液和脑脊液样本的标准操作程序 存储传入的和结果的高维数据。考虑到涉及的海量数据，以及 在进行复杂的分析时，必须以协调的方式进行工作，以保持 严密性和可重复性。MCT将依靠临床人工智能中的综合专业知识 和成像核心以及分子数据科学和高级剂量学核心，以确保合规性 具有去身份识别和数据存储标准，使Robin生成的丰富资源可以 在试点项目和其他项目中被更广泛的研究界有效利用。