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）

基本信息

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
项目类别：
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

项目摘要

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.

项目概要/摘要 NCI 指定的丹娜—法伯/哈佛癌症中心 (DF/HCC) 包括丹娜—法伯癌症研究所 (DFCI)/布莱根妇女医院 (BWH)、马萨诸塞州总医院 (MGH) 和贝斯以色列医院女执事医疗中心 (BIDMC)，共同组成了一个领先的学术组织 (LAO) 综合 NCI 实验治疗临床试验网络 (ETCTN)。在 UM1 的赞助下合作协议，DF/HCC LAO 参与了 15 个 NCI-CTEP 项目组，并具有领导在 6 个团队中担任职务，领导了 20 项 ETCTN 试验并参与了 43 项研究，平均每个研究有 102 名参与者过去 5 年的一年。我们的 LAO 采用多重 PD/PI 结构，包括 (1) 转化核心具有信号转导、细胞周期、DNA 修复和生物标志物开发专业知识的研究人员免疫肿瘤学药物，以及熟练掌握液体活检分析、计算生物学和旁台细胞系、类器官和 PDX 模型开发； (2) 进行第一阶段和篮子的研究者研究，以及与 DF/HCC 计划和 SPORE 合作的八位主要疾病研究人员领导者进行针对特定疾病的 ETCTN 试验； (3) DF/HCC介入放射学代表，研究病理学和生物统计学； (4) 指导监管监督的领导者，强有力的指导早期职业临床和转化研究人员计划以及旨在提高 ETCTN 试验中服务不足人群的入组。通过持续参与 NCI 项目团队并利用 DF/HCC 转化科学，DF/HCC 研究人员将制定意向书并利用 CTEP IND 药物作为单一疗法或合理组合的统计上严格的方案，将与其他 ETCTN 站点合作有效地进行和报告。此外，我们的调查人员将积累由其他 LAO 领导的 ETCTN 研究，总体目标是至少 30% 的网络参与度，并且每年招生100人。研究人员将利用 DF/HCC 核心和 NCI 中心实验室来将经过验证的整体和综合生物标志物测定以及探索性生物标志物纳入试验设计中，检查选定患者群体中治疗活性的原理证明证据、机制证明目标参与的证据，以及反应、途径适应和抵抗的特征。这 DF/HCC LAO 将继续广泛致力于培训早期职业研究者发展疗法和旨在增加人口多样性的战略举措参加 ETCTN 试验。