Dana-Farber/Harvard Cancer Center Experimental Therapeutics Clinical Trials Network Site (DF/HCC ETCTN Site) - Incorporation of Mayo Clinic Cancer Center as an Affiliated Center

Dana-Farber/哈佛大学癌症中心实验治疗临床试验网络网站（DF/HCC ETCTN 网站）- 梅奥诊所癌症中心并入附属中心

• 批准号: 10393266
• 负责人: KEITH T FLAHERTY
• 金额: $ 10万
• 依托单位: DANA-FARBER CANCER INST
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-03-13 至 2023-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10393266
• 关键词: Address; Administrative Supplement; Advanced Malignant Neoplasm; Antibody-drug conjugates; Arizona; Biometry; Cancer Center; Cancer Therapy Evaluation Program; Catchment Area; Clinic; Clinical Cancer Center; Clinical Investigator; Clinical Trials; Clinical Trials Network; DNA Repair; Dana-Farber Cancer Institute; Discipline; Disease; Enrollment; Ensure; Florida; Funding; General Hospitals; Hematologic Neoplasms; Immunooncology; Interventional radiology; Investigational Therapies; Israel; Lead; Leadership; Letters; Malignant Neoplasms; Massachusetts; Mayo Clinic Cancer Center; Medical center; Mentors; Mentorship; Minority Enrollment; Minority Groups; Pathology; Patients; Research; Research Personnel; Rural Population; Science; Site; Solid Neoplasm; Therapeutic; Translating; U-Series Cooperative Agreements; Woman; Work; biomarker-driven; career; early phase clinical trial; improved; inhibitor/antagonist; member; patient population; pre-clinical; programs; rural underserved; translational scientist; tumor metabolism

PROJECT SUMMARY/ABSTRACT This application is being submitted to request additional funds for Mayo Clinic Cancer Center (MCCC) as an Affiliated Organization (AO) to the Dana-Farber/Harvard Cancer Center (DF/HCC) Experimental Therapeutics Clinical Trials Network (ETCTN) Lead Academic Organization (LAO). MCCC investigators, led by Dr. Alex A. Adjei and representing the Mayo Clinic Rochester, Florida and Arizona sites, have been incorporated into the DF/HCC LAO Leadership and Steering Committee, Governance Committee and Translational Core. Additionally, they are participating as disease-focused clinical investigators, with support from MCCC interventional radiology, pathology and biostatistics. Work conducted under this supplement will facilitate the continuation and completion of MCCC-led ETCTN trials that address inhibitors of DNA repair and tumor metabolism, as well as immuno-oncology combinations and antibody drug conjugates across solid tumors and hematologic malignancies. Emphasis will be placed on the continued mentorship of MCCC early career investigators, manifested in part by support afforded by the DF/HCC LAO Scholars in Cancer Experimental Therapeutics (SCET) Program. As an AO, it is anticipated that over the next year, MCCC investigators will enroll a minimum of 20 patients to ETCTN trials and submit Project Team Member Applications (PTMAs) and other clinical trial proposals culminating in at least two approved letters of intent (LOIs). MCCC investigators will also coordinate with DF/HCC to ensure that the LAO consistently demonstrates at least 30% network participation, with at least 6 trials open in relevant disease-focused disciplines with 10 enrollments per disease group. Finally, MCCC investigators will also work with DF/HCC to increase the enrollment of under- represented and rural populations to ETCTN trials by leveraging the catchment area encompassed by MCCC sites.

项目概要/摘要 提交此申请是为了为 Mayo Clinic 癌症中心 (MCCC) 作为一个 丹娜法伯/哈佛大学癌症中心 (DF/HCC) 实验治疗学附属组织 (AO) 临床试验网络 (ETCTN) 领导学术组织 (LAO)。 MCCC 调查员由 Alex A. 博士领导。 Adjei 代表 Mayo Clinic 罗彻斯特、佛罗里达州和亚利桑那州站点，已并入 DF/HCC LAO 领导和指导委员会、治理委员会和转化核心。 此外，他们在 MCCC 的支持下作为以疾病为重点的临床研究人员参与 介入放射学、病理学和生物统计学。根据本补充文件开展的工作将有助于 继续并完成 MCCC 领导的 ETCTN 试验，研究 DNA 修复和肿瘤抑制剂 代谢，以及跨实体瘤和免疫肿瘤学组合和抗体药物偶联物 血液系统恶性肿瘤。重点将放在 MCCC 早期职业生涯的持续指导上 研究人员，部分体现在 DF/HCC LAO 学者在癌症实验方面提供的支持 治疗 (SCET) 计划。作为 AO，预计 MCCC 调查人员将在明年 招募至少 20 名患者参加 ETCTN 试验并提交项目团队成员申请 (PTMA) 和 其他临床试验提案最终获得至少两份批准的意向书 (LOI)。 MCCC调查员 还将与 DF/HCC 协调，确保 LAO 始终展示至少 30% 的网络 参与，在相关疾病重点学科中至少开展 6 项试验，每种疾病有 10 名患者入组 团体。最后，MCCC 调查人员还将与 DF/HCC 合作，增加低收入儿童的入学率 利用 MCCC 涵盖的服务区域，让代表性人口和农村人口参与 ETCTN 试验 网站。