Clinical Translational Core

项目摘要 肺癌和前列腺癌一起构成癌症患者的显著比例。这些疾病是 早期发现可治愈;然而，当疾病进展时， 在治疗过程中，显然需要更早地做出决定。纳米技术 在CCNE-TD中开发的非常适合于推进肺部的早期检测和治疗监测， 前列腺癌，有可能改变癌症护理。临床翻译核心（核心2）团队是 由一组医生和科学家组成，他们在开发新技术方面具有特殊经验， 前列腺癌和肺癌的早期检测和治疗监测， 将CCNE-TD内开发的纳米技术投入临床应用。 本核心中临床研究者的早期投入将有助于避免：（1）研究技术的开发 与癌症相关性有限的参数;（2）具有排除的后勤或物理限制的方案 最终的临床翻译;以及（3）由于适当的临床研究者、批准 研究人员尚未到位（这一过程可能需要6个月至1年）。核心2将协助项目 PI开发和实施临床翻译路径，并在项目生命周期内提供持续支持， 从早期的技术开发，到试点临床试验，一直到规划潜在的验证 问题研究CCNE机制不允许为前瞻性临床试验提供资金。然而，临床 翻译核心将为试点项目提供高质量的样本，以连接其他资助活动 为我们全心全意致力的临床试验申请新的资金。 核心2致力于协助每个研究项目负责人实现以下目标：1）确定内部 和外部来源的临床标本/病人，以促进纳米技术的发展; 2）获取材料 3）获得机构审查委员会的豁免或批准， 4）为项目提供抗体和样本进行试点测试， 要求（核心2将确保访问3个肺癌和2个前列腺癌临床样本库，以及 作为3个库，包括其他癌症类型）; 5）与外部机构，包括NCI的接口 纳米表征实验室和美国食品药品监督管理局代表 首次人体研究的项目PI;以及6）就临床试验资金来源的提案准备提供咨询。 在CCNE-TD的5年中，我们预计Core 2将分发6-8种定制抗体或抗体 碎片，>400份血浆或血清样品，>100份全血或新鲜组织样品，以及>100份肿瘤 向我们的调查人员提供样本临床和翻译核心将促进以下内容的临床实施： CCNE-TD纳米技术，并将大大有助于该中心的整体成功。

Project Summary Lung and prostate cancer together comprise a significant proportion of patients with cancer. These diseases are curable when detected early; however, when disease is advanced, more sophisticated ways to monitor response to therapy are clearly needed to make earlier decisions during the treatment course. The nanotechnologies developed in the CCNE-TD are well suited to advance early detection and therapeutic monitoring in lung and prostate cancer, with the potential to transform cancer care. The Clinical Translational Core (Core 2) team is comprised of a team of physicians and scientists with specific experience in developing new technologies for early detection and therapeutic monitoring in Prostate and Lung Cancers who are committed to moving nanotechnologies developed within the CCNE-TD into clinical application. Early input from clinical investigators in this Core will help avoid: (1) Development of technologies to study parameters of limited relevance to cancer; (2) Protocols with logistical or physical limitations that preclude eventual clinical translation; and (3) Delays in development because the proper clinical investigators, approvals and study staff have not been put in place (a process that can take 6 months to a year). Core 2 will assist project PIs to develop and implement a path for clinical translation with continuous support over the lifetime of the project, from early technology development, through pilot clinical testing, all the way to planning potential validation studies. The CCNE mechanism does not allow funding for prospective clinical trials. Nevertheless, the Clinical Translational Core will provide high quality specimens for pilot projects to bridge to other funded activities as well as apply for new funding for clinical trials to which we are whole-heartedly committed. Core 2 is dedicated to assisting each of the research project leaders achieve the following: 1) Identify internal and external sources of clinical specimens/patients to facilitate nanotechnology development; 2) Acquire material transfer agreements to receive clinical specimens 3) Obtain Institutional Review Board exemption or approval to use the nanotechnology in ex vivo samples 4) Provide antibodies and specimens to projects for pilot testing as required (Core 2 will secure access to 3 lung cancer and 2 prostate cancer clinical sample repositories, as well as 3 repositories that include additional cancer types); 5) Interface with external agencies including the NCI's Nanocharacterization Lab, and Food and Drug Administration for Investigational New Drug filings on behalf of project PI's for first-in-man studies; and 6) Consult on preparation of proposals for sources of clinical trial funding. Over the 5 years of CCNE-TD, we anticipate that Core 2 will distribute 6-8 custom antibodies or antibody fragments, >400 plasma or serum samples, >100 whole blood or fresh tissue samples, and >100 tumor specimens to our investigators. The Clinical and Translational Core will facilitate clinical implementation of CCNE-TD nanotechnologies and will contribute significantly to the center's overall success.