Coordinating and Data Management Center for Translational and Basic Science Research in Early Lesions

项目摘要 癌症的早期诊断可以提高治疗效果，延长患者的生存时间。越来越多的 敏感和广泛采用的早期癌症筛查技术已导致更多的检测 可能或不会进展为癌症的早期病变。阐明驱动或抑制的机制 早期癌症可以区分侵袭性癌症和惰性癌症，改善 个体化治疗，避免过度诊断和过度治疗。是否为早期病变 是否进展为癌症不仅仅由病变的分子特征决定，而且还受到影响 受周围微环境和其他流行病学因素的影响。同时， 早期病变向恶性肿瘤的进展是一个复杂的过程，可能需要数年时间才能发生。这个 这个问题的复杂性突显了从基础科学到翻译科学的研究人员尚未得到满足的需求 合作和协调研究早期损伤和疾病的潜在机制 癌症的发展。针对RFA-CA-21-055，我们提出了一种协调和数据管理 美国疾病控制与预防中心(CDMC)的早期病变转化和基础科学研究(TBEL)计划。这个 CDMC与方案的其他实体密切互动，包括指导委员会、 研究中心、生物显微镜和图像存储库、病理中心、测序设施、数据和 安全监测委员会(DSMB)和NCI，并提供关键的科学、管理、监管和 为TBEL计划提供管理、后勤和数据分析支持。我们建议的CDMC基础设施 和操作程序已经在一个由NIH资助的正在进行的研究财团中进行了时间测试 慢性胰腺炎、糖尿病和胰腺癌。具体地说，拟议的工作包括三个方面 所需职责的各个方面：联合体协调(目标1)、统计和计算 支助(目标2)、数据管理、研究方案的制定和实施(目标3)。我们的 专家团队包括一直在支持和开发的信息技术专家 用于众多基础和翻译癌症研究、经验研究的创新软件工具 曾参与美国国立卫生研究院和行业资助的多中心研究的协调员和教职员工 曾领导CDMC为大型NIH财团工作的统计学家和生物信息学家- 生物统计学和生物信息学方法论研究领域的知名专家 生物标志物开发、风险预测、单细胞分析、图像分析、机器学习和 临床试验。

Project Summary Early diagnosis of cancer can improve therapeutic effect and prolong patient survival. The increasingly sensitive and widely adopted early cancer screening technologies have led to significantly more detection of early lesions that may or may not progress to cancer. Elucidating the mechanisms that drive or restrain early cancer would allow differentiation of aggressive cancer versus indolent types, improving personalized treatment and avoiding over-diagnosis and over-treatment. Whether an early lesion progress to cancer or not is not solely decided by the molecular profile of the lesion but also is impacted by the surrounding microenvironment and mediated by other epidemiologic factors. Meanwhile, the progression of an early lesion to malignancy is a complex process that may take years to occur. The complexities of the problem highlight the unmet needs for researchers from basic to translational science to collaborate and coordinate in the research of the underlying mechanisms between early lesion and cancer development. In response to RFA-CA-21-055, we propose a Coordinating and Data Management Center (CDMC) for the Translational and Basic Science Research in Early Lesions (TBEL) Program. The CDMC interacts closely with other entities of the Program, including the Steering Committee, the Research Centers, biospecimen and image repository, pathology centers, sequencing facilities, Data and Safety Monitoring Board (DSMB), and NCI, and provides critical scientific, administrative, regulatory, managerial, logistic, and data-analytic support to the TBEL Program. Our proposed CDMC infrastructure and operating procedures have been time-tested in an ongoing NIH-funded Consortium for the Study of Chronic Pancreatitis, Diabetes and Pancreatic Cancer. Specifically, the proposed work includes the three aspects of required responsibilities: consortium coordination (Aim 1), statistical and computational support (Aim 2), and data management, study protocol development and implementation (Aim 3). Our team of experts include information technology specialists who have been supporting and developing innovative software tools for numerous basic and translation cancer studies, experienced research coordinators who have worked on both NIH- and industry-funded multicenter studies, and faculty statisticians and bioinformaticians who have led CDMC work for large NIH consortiums and are well- known experts in biostatistics and bioinformatics methodological research areas closely related to biomarker development, risk prediction, single cell analysis, image analysis, machine learning, and clinical trials.