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：本申请旨在申请增设堪萨斯大学癌症中心 （KUCC）作为NCI实验治疗-临床试验网络的附属组织（AO） （ETCTN）UM 1领导学术组织。KUCC，以前是一个“创造获得靶向癌症治疗的途径” 为服务不足的人群（赶上）”网站将提高在早期治疗临床试验的访问 在堪萨斯为服务不足的人群提供试验网络（USP），并将USP增强到我们的ETCTN联盟。的 ETCTN的目的是开发新的治疗选择，同时也定义更好的方法， 开发利用肿瘤分子特征的新型抗癌药物。作为 因此，一个独特的网络，如ETCTN，由多个科学驱动的网站和调查人员组成 拥有大量专业知识的人。于二零二零年，我们获得UM 1资助（2UM 1CA 186689 -06）。七月 2022年，NCI癌症治疗评估计划（CTEP）建议我们提交这份行政报告。 补充资金，以抵消吸收KUCC作为额外的AO以保持CATCH的连续性的部分费用， 参与ETCTN活性试验的UP研究中心（患者正在接受治疗和随访的研究中心）以及 从USP招募更多患者，以增加新治疗药物对这些相应药物的可及性 人口。我们最初的合作伙伴包括范德比尔特-英格拉姆，加州圣地亚哥大学， 俄克拉荷马州斯蒂芬森癌症中心和耶鲁大学癌症中心（VICtOrY）。我们随后补充说， 哥伦比亚大学、圣路易斯的华盛顿大学和佛罗里达大学。我们现在计划增加 KUCC向我们的联合体提供资金，组建VICtOrY-CWFK。我们的团队旨在1）利用新的科学发现， 转化为早期试验，使用CTEP药典，在罕见癌症，常见癌症， 常见癌症的不常见变体; 2）结合血清、组织和成像生物标志物，以更好地 了解单独或联合使用新型药物的效果; 3）培训早期职业调查人员， 通过提供临床研究领导，了解并精通早期临床试验 机会和指导;以及4）作为我们早期临床试验招募的一部分， 超过30%的USP人群，包括20%的传统少数民族/种族患者 在KUCC招募的至少50% USP。我们的团队成员，沿着提议的额外地点， 拥有一套独特的互补专业知识和类似的合作研究理念， 下一代癌症研究者的导师。VICtOrY-CWFK致力于利用 我们的专业领域，在我们的机构整合科学，并最大限度地提高我们的合作关系 在ETCTN内进行尖端的早期试验，其最终使命是改善结果 for cancer癌症patients病人.