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.

项目总结/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）、马萨诸塞州总医院（MGH）和贝斯以色列 女执事医疗中心（BIDMC），共同组成了一个领先的学术组织（LAO）在 NCI实验治疗药物临床试验网络（ETCTN）。在UM 1的赞助下， 根据合作协议，DF/HCC LAO参与了15个NCI-CTEP项目团队，并担任领导职务。 在6个团队中担任角色，领导了20项ETCTN试验，参与了43项研究，平均每个团队有102例入组 在过去的五年里。我们的LAO利用多个PD/PI结构，包括（1）翻译的核心 具有信号转导、细胞周期、DNA修复和 免疫肿瘤学试剂，以及在液体活检分析、计算生物学和实验室旁细胞系、类器官和PDX模型开发方面的熟练程度;（2）进行I期和篮式研究的研究者 研究，以及与DF/HCC项目和SPORE合作的8名主要疾病研究者 领导开展疾病特异性ETCTN试验;（3）DF/HCC介入放射学的代表， 研究病理学和生物统计学;（4）领导谁直接监管监督，一个强大的辅导 为早期职业临床和翻译研究人员和推广活动，旨在增加 在ETCTN试验中招募服务不足的人群。通过继续参与NCI项目团队 利用DF/HCC转化科学，DF/HCC研究人员将制定意向书， 使用CTEP IND药物作为单药治疗或合理组合的统计学严格方案， 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 将计入由其他LAO领导的ETCTN研究，总体目标是至少30%的网络参与率， 每年招收100人。研究者将利用DF/HCC核心和NCI中心实验室， 在试验设计中纳入经验证的整体和综合生物标志物测定和探索性生物标志物， 在选定的患者人群中检查治疗活性的原理证明证据， 目标参与的证据，以及反应、途径适应和抗性的特征。的 DF/HCC LAO将继续广泛致力于培训早期职业调查员， 发展治疗和战略举措，预计将增加人口的多样性 参加ETCTN试验。