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.

项目摘要 分子表征试验（MCT）是罗宾生物测量和数据资源的来源 中心。因此，它的成功对于整个倡议的成功和加快的策略至关重要 这些基本资源的获取将加速可供使用的时间表 在研究项目和核心中进行的所有创新工作。哈佛/UCSF罗宾已选择 对于其主题，研究小儿恶性肿瘤是对影响的最佳环境 异质性，在其肿瘤细胞的固有和外在表现中，都在辐射反应上。 MCT 将通过以下目的实现这些目标：目标1：协调生物测量的收集和 来自教练小组研究的临床数据用于罗宾研究。 MCT将利用两个正在进行的 试验：太平洋小儿神经肿瘤联盟PNOC023用于弥漫性中线神经胶质瘤（DMG）和 儿童肿瘤学组（COG）ANBL1531用于神经母细胞瘤（NBL）。每个试验的研究椅都是共同的 MCT和项目2的引线。作为MCT的新功能，匹配的肿瘤样品对 将从接受治疗前活检并随后进行后处理的受试者提供 通过既定方案获得的手术（NBL）或验尸（DMG）组织。罗宾调查人员将 还利用他们独特可用的其他资源，包括三十dmg的集合 与在PNOC023研究中获得的肿瘤样品不同。 MCT会 还通过从COG后期效应中获得血液样本和临床数据来增强对后期作用的目标 高风险神经母细胞瘤（Leahrn）研究，其中包括24种先前用该研究的长期生存 放射药131i-mibg。目标2：管理MCT的监管方面，包括站点协议 用于在机构生物库中收集受保护的健康信息（PHI）和生物测量。临床 研究和数据协调员将与Dana-Farber/Harvard Cancer Center和 UCSF确保严格，及时提交研究方案，修订和持续审查，因此 这项工作可以坚定地进行。而且，由于所有PHI都将流过MCT，因此 将资源识别为其他罗宾组件，这将最大程度地降低主体机密性的风险。目标3： 维护用于处理和分析肿瘤，血液和CSF样品的标准操作程序，以及 存储收入和最终的高维数据。考虑到涉及大量数据，以及 正在进行复杂的暗示，必须以统一的方式进行工作以维护工作 严格和可重复性。 MCT将依靠临床人工智能中的联合专业知识 以及成像核心以及分子数据科学和高级剂量核心核心，以确保合规性 具有去识别和数据存储标准，以使罗宾产生的丰富资源可以是 在试点项目及其他地区，更广泛的研究社区有效地使用了。