Supplement to UM1 grant for NCI's Early Therapeutics Clinical Trials Network (ETCTN)

NCI 早期治疗临床试验网络 (ETCTN) 的 UM1 补助金补充

• 批准号: 10678278
• 负责人: PATRICIA M. LORUSSO
• 金额: $ 50万
• 依托单位: YALE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-01 至 2023-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10678278
• 关键词: Administrative Supplement; Area; Award; Back; Belief; Biological Markers; California; Cancer Center; Cancer Patient; Cancer Therapy Evaluation Program; Clinic; Clinical; Clinical Research; Clinical Trials; Clinical Trials Network; Collaborations; Data; Development; Drug Delivery Systems; Drug Kinetics; Early Therapeutic-Clinical Trials Network; Faculty; Florida; Funding; Geography; Goals; Grant; Infrastructure; Institution; Investigation; Investigational Therapies; Kansas; Laboratories; Lead; Leadership; Letters; Malignant Neoplasms; Mentors; Mentorship; Methods; Minority Groups; Mission; Molecular; Oklahoma; Parents; Patient Recruitments; Patient Selection; Patients; Pharmacodynamics; Pharmacopoeias; Phase; Philosophy; Population; Protocols documentation; Recommendation; Reporting; Research; Research Design; Research Personnel; Rural Population; Science; Selection for Treatments; Serum; Services; Site; Special Population; Therapeutic; Therapeutic Agents; Toxic effect; Training; Translating; Translational Research; Translations; Underserved Population; Universities; Variant; Washington; Work; Yale Cancer Center; career; clinical investigation; cohesion; cost; design; drug development; early phase clinical trial; early phase trial; follow-up; imaging biomarker; improved outcome; member; minority patient; next generation; novel; novel anticancer drug; novel therapeutics; patient biomarkers; racial and ethnic; rare cancer; recruit; resistance mechanism; response; student mentoring; targeted cancer therapy; tissue biomarkers; translational medicine; treatment optimization; tumor

ABSTRACT: This application is being submitted to request the addition of University of Kansas Cancer Center (KUCC) as an Affiliated Organization (AO) to our NCI Experimental Therapeutics-Clinical Trials Network (ETCTN) UM1 Lead Academic Organization. KUCC, previously a “Create Access to Targeted Cancer Therapy for Underserved Populations (CATCH-UP)” site will enhance access of trials in the Early Therapeutics Clinical Trials Network for underserved populations (USP) in Kansas and enhance USP to our ETCTN consortium. The purpose of the ETCTN is to develop new therapeutic options while also defining better approaches for the development of novel anticancer agents that capitalize on the ability to characterize tumors molecularly. As a result, a unique network such as the ETCTN, consisting of multiple scientifically-driven sites and investigators with a vast array of expertise, is needed. In 2020, we were awarded a UM1 grant (2UM1CA186689-06). In July 2022, the NCI Cancer Therapy Evaluation Program (CTEP) recommended that we submit this administrative supplement to offset some of the costs of absorbing KUCC as an additional AO to provide continuity for CATCH- UP sites participating on ETCTN active trials (those with patients on treatment and in follow-up) as well as recruit additional patients from USP to increase access of novel therapeutic agents to these respective populations. Our original partnerships included Vanderbilt-Ingram, University of California San Diego, University of Oklahoma Stephenson Cancer Center and the Yale Cancer Center (VICtOrY). We subsequently added Columbia University, Washington University in St. Louis, and the University of Florida. We now plan to add KUCC to our consortium to form VICtOrY-CWFK. Our team aims to 1) leverage novel scientific discoveries for translation into early phase trials, using the CTEP pharmacopeia, in rare cancers, common cancers, and uncommon variants of common cancers; 2) incorporate serum, tissue and imaging biomarkers to better understand the effects of novel agents either alone or in combination; 3) train early career investigators to be knowledgeable and proficient in conducting early phase clinical trials by providing clinical research leadership opportunities and mentoring; and 4) include as a component of our early phase clinical trial recruitment, no less than 30% USP populations including 20% consisting of traditional ethnic/racial minority patients with recruitment of at least 50% USP recruited at KUCC. The members of our team, along with the proposed additional site, have a unique set of complementary expertise and a similar philosophy regarding collaborative research and mentorship of the next generation of cancer investigators. Together, VICtOrY-CWFK is committed to utilizing our areas of expertise, integrating the science at our institutions, and maximizing our collaborative relationships to conduct cutting-edge early phase trials within the ETCTN with the ultimate mission of improving outcomes for cancer patients.

摘要：该申请被提交要求增加堪萨斯大学癌症中心 （KUCC）作为我们的NCI实验性治疗临床试验网络的附属组织（AO） （ETCTN）UM1领导学术组织。 KUCC，以前是“创建目标癌症治疗 对于服务不足的人群（追赶）”站点将增强早期治疗临床中试验的访问 堪萨斯州服务不足人群（USP）的试验网络，并将USP提高到我们的ETCTN财团。这 ETCTN的目的是开发新的治疗方案，同时还为更好的方法定义了更好的方法 开发新型抗癌药，这些抗癌药利用了分子表征肿瘤的能力。作为 结果是一个独特的网络，例如ETCTN，由多个科学驱动的站点和研究人员组成 需要大量的专业知识。在2020年，我们获得了UM1赠款（2UM1CA186689-06）。在七月 2022年，NCI癌症治疗评估计划（CTEP）建议我们提交此行政 补充以抵消吸收KUCC作为额外AO的一些成本，以提供连续性 UP参加ETCTN主动试验的站点（接受治疗和随访的患者）以及 从USP招募更多患者，以增加新型治疗剂的获取 人群。我们的最初合作伙伴关系包括加利福尼亚大学圣地亚哥分校的范德比尔特 - 伊格兰 俄克拉荷马州斯蒂芬森癌症中心和耶鲁癌症中心（胜利）我们随后添加 哥伦比亚大学，圣路易斯华盛顿大学和佛罗里达大学。我们现在计划添加 KUCC到我们的财团形成胜利-CWFK。我们的团队的目标是1）利用新颖的科学发现 在罕见的癌症，普通癌和 常见癌症的罕见变体； 2）将血清，组织和成像生物标志物纳入更好 了解单独或组合新型代理的影响； 3）训练早期职业调查人员成为 通过提供临床研究领导才能知识渊博并精通进行早期临床试验 机会和指导； 4）包括我们早期临床试验招募的组成部分 超过30％的USP人群，包括20％的招聘少数民族/种族少数民族患者 在KUCC招募的至少50％的USP。我们团队的成员以及拟议的其他网站 拥有一套独特的补充专业知识，以及有关协作研究的类似理念， 下一代癌症研究者的遗传。一起，胜利-CWFK致力于使用 我们的专业知识领域，将科学纳入机构，并最大化我们的协作关系 在ETCTN内进行尖端的早期试验，以改善结果的最终任务 适用于癌症患者。