Dana-Farber/Harvard Cancer Center Experimental Therapeutics Clinical Trials Network Site (DF/HCC ETCTN Site)

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）

• 批准号: 10784840
• 负责人: KEITH T FLAHERTY
• 金额: $ 255.54万
• 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 2026-02-28
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10784840
• 关键词: Acceleration; Advanced Malignant Neoplasm; Basic Science; Biological Assay; Biological Markers; Biometry; Biopsy; Cancer Center; Cancer Therapy Evaluation Program; Catchment Area; Cell Cycle; Cell Line; Center for Translational Science Activities; Clinical; Clinical Investigator; Clinical Research; Clinical Sciences; Clinical Trials; Clinical Trials Design; Clinical Trials Network; Collaborations; Computational Biology; DNA Repair; Dana-Farber Cancer Institute; Development; Development Plans; Developmental Therapeutics Program; Discipline; Disease; Drug Kinetics; Drug resistance; Enrollment; Fostering; General Hospitals; Genomics; Goals; Grant; Guidelines; Hospitals; Immunologic Monitoring; Immunooncology; Institution; Intervention; Interventional radiology; Investigational Therapies; Israel; Laboratories; Lead; Leadership; Letters; Malignant Neoplasms; Massachusetts; Medical center; Mentors; Mentorship; Molecular; Organoids; Outcome; Pathologist; Pathology; Pathway interactions; Patient Selection; Patients; Pharmacodynamics; Phase; Population Heterogeneity; Program Development; Protocols documentation; Reporting; Reproduction spores; Research; Research Design; Research Personnel; Resistance; Resources; Risk Assessment; Role; Safety; Science; Signal Transduction; Site; Structure; Therapeutic; Training; Translating; Translational Research; U-Series Cooperative Agreements; Underserved Population; Woman; Work; Writing; assay development; biomarker development; biomarker driven; cancer type; career; career development; clinical development; clinical trial protocol; cohort; design; drug development; drug sensitivity; early phase clinical trial; experience; improved; liquid biopsy; meetings; member; model development; multidisciplinary; novel; oncology trial; outreach; outreach program; patient derived xenograft model; patient population; pre-clinical; programs; protocol development; radiologist; response; sound; success; translational scientist; trial design; working group

PROJECT SUMMARY/ABSTRACT The NCI-designated Dana-Farber/Harvard Cancer Center (DF/HCC) includes the Dana-Farber Cancer Institute (DFCI)/Brigham and Women's Hospital (BWH), Massachusetts General Hospital (MGH) and the Beth Israel Deaconess Medical Center (BIDMC), which together comprise a Lead Academic Organization (LAO) in the integrated NCI Experimental Therapeutics Clinical Trials Network (ETCTN). Under the auspices of a UM1 Cooperative Agreement, the DF/HCC LAO has participated in 15 NCI-CTEP project teams, with leadership roles on 6 teams, led 20 ETCTN trials and participated in 43 studies, with an average of 102 enrollments per year over the last 5 years. Our LAO utilizes a multiple PD/PI structure and includes (1) a core of translational investigators with expertise in biomarker development for signal transduction, cell cycle, DNA repair and immuno-oncology agents, as well as proficiency in liquid biopsy analyses, computational biology and beside-to-bench cell line, organoid and PDX model development; (2) investigators who conduct Phase 1 and basket studies, as well as eight lead disease-focused investigators who work with DF/HCC Program and SPORE leaders to conduct disease-specific ETCTN trials; (3) representatives of DF/HCC interventional radiology, research pathology and biostatistics; and (4) leaders who direct regulatory oversight, a robust mentoring program for early career clinical and translational investigators and outreach activities designed to increase the enrollment of underserved populations in ETCTN trials. Through continued participation in NCI Project Teams and the leveraging of DF/HCC translational science, DF/HCC investigators will develop letters of intent and statistically rigorous protocols utilizing CTEP IND agents as monotherapies or in rational combinations that will be efficiently conducted and reported in collaboration with other ETCTN sites. Additionally, our investigators will accrue to ETCTN studies led by other LAOs with the overall goal of at least 30% network participation and 100 enrollments per year. Investigators will utilize both DF/HCC cores and NCI central laboratories to incorporate validated integral and integrated biomarker assays and exploratory biomarkers in trial designs that examine proof-of-principle evidence of therapeutic activity in selected patient populations, proof-of-mechanism evidence of target engagement, as well as signatures of response, pathway adaptation and resistance. The DF/HCC LAO will maintain extensive commitments to the training of early career investigators in developmental therapeutics and to strategic initiatives expected to increase the diversity of the population enrolled to ETCTN trials.

项目摘要/摘要 NCI指定的Dana-Farber/哈佛癌症中心(DF/HCC)包括Dana-Farber癌症研究所 (DFCI)/布里格姆妇女医院(BWH)、马萨诸塞州综合医院(MGH)和以色列贝丝医院 女执事医疗中心(BIDMC)，共同组成一个领导学术组织(LAO)在 综合NCI实验治疗临床试验网络(ETCTN)。在UM1的赞助下 根据《合作协议》，DF/CC LAO参加了15个NCI-CTEP项目小组，并担任领导 在6个团队中扮演角色，领导20项ETCTN试验并参与43项研究，平均每项研究102人 在过去的5年里。我们的LAO使用多PD/PI结构，并包括(1)翻译的核心 在信号转导、细胞周期、DNA修复和生物标志物开发方面具有专业知识的研究人员 免疫肿瘤学药物，以及精通液体活组织检查分析、计算生物学和体外细胞系、有机体和PDX模型开发；(2)进行第一阶段和篮子的调查人员 研究，以及与DF/HCC计划和孢子合作的8名以疾病为重点的首席调查人员 领导进行疾病特异性ETCTN试验；(3)DF/HCC介入放射学代表， 研究病理学和生物统计学；以及(4)直接监管的领导，强有力的指导 为职业生涯早期临床和翻译研究人员提供的计划以及旨在增加 在ETCTN试验中登记未得到充分服务的人群。通过继续参与NCI项目团队 并利用DF/HCC翻译科学，DF/HCC调查人员将制定意向书和 将CTEP IND制剂作为单一疗法或以合理组合使用的统计严格的方案 与其他ETCTN网站合作，有效地进行和报告。此外，我们的调查人员 将增加由其他老挝牵头的ETCTN研究，总体目标是至少30%的网络参与和 每年招生100人。调查人员将利用DF/HCC核心和NCI中央实验室来 在试验设计中纳入经过验证的整体和综合生物标志物分析和探索性生物标志物 在选定的患者群体中检查治疗活性的原则证据，机制证据 目标参与的证据，以及反应、途径适应和抗药性的信号。这个 DF/CC Lao将继续广泛致力于培训#年的早期职业调查人员 发展疗法和预期增加人口多样性的战略举措 注册参加ETCTN试验。