Case Comprehensive Cancer Center NCTN Lead Academic Participating Site

案例综合癌症中心 NCTN 领先学术参与站点

• 批准号: 10360582
• 负责人: Aaron Thomas Gerds
• 金额: $ 142.49万
• 依托单位: CASE WESTERN RESERVE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-03-15 至 2025-02-28
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10360582
• 关键词: Address; Advisory Committees; American College of Radiology Imaging Network; Biological Markers; Brain; Breast; Cancer Center; Cancer Patient; Clinic; Clinical; Clinical Data; Clinical Research; Clinical Trials; Clinical Trials Network; Clinical Trials Unit; Communication; Communities; Community Clinical Oncology Program; Component of the National Cancer Institute; Comprehensive Cancer Center; County; Data; Data Analyses; Development; Developmental Therapeutics Program; Diagnosis; Disease; Eastern Cooperative Oncology Group; Education; Educational process of instructing; Ensure; Faculty; Funding; Future; Generations; Genitourinary system; Goals; Gynecologic; Hematology; Hospitals; Image; Individual; Industry; Infrastructure; Institution; Investigation; Lead; Leadership; Lung; Malignant Neoplasms; Mentors; Meta-Analysis; Minority; Mission; Multi-Institutional Clinical Trial; National Cancer Institute; National Clinical Trials Network; Ohio; Oncology; Operative Surgical Procedures; Orphan; Patient Care; Patients; Phase; Physicians; Pilot Projects; Population Heterogeneity; Positioning Attribute; Procedures; Protocols documentation; Quality Control; Quality of life; Radiation; Research; Research Personnel; Role; Services; Site; Southwest Oncology Group; System; Time; Tissue Sample; Translational Research; Underrepresented Populations; Universities; University Hospitals; Vision; base; biobank; cancer care; cancer therapy; cancer type; clinical diagnostics; clinical infrastructure; data management; data submission; design; experience; gastrointestinal; improved; improved outcome; industry partner; innovation; interest; medical schools; medical specialties; meetings; melanoma; member; operation; performance site; phase II trial; programs; prospective; protocol development; quality assurance; rare cancer; recruit; secondary analysis; success

PROJECT SUMMARY This project represents the comprehensive efforts of the oncology community at Case Western Reserve University School of Medicine and its three major teaching affiliate hospitals (University Hospitals, Cleveland Clinic, and MetroHealth) to participate as a Lead Academic Participating Site in the National Clinical Trials Network (NCTN). The NCTN, funded and directed by the National Cancer Institute (NCI), is the major consortium for performing federally-funded, national multicenter clinical trials that aim to improve outcomes for cancer patients. The emphasis of NCTN trials is late phase (phase III and relatively large Phase II) trials that address scientific questions that usually cannot be answered by other means such as a single-institution study or an industry company study. The results of these trials often set the standards of care for cancer treatment in the U.S. and the world. This includes clinical trials research in rare cancers and underrepresented populations. Our specific aims for this project are 1) to participate in NCTN trials with exceptionally high levels of accrual volume and quality of data generation and submission for approximately 240 new patients per year; 2) to serve the NCTN and the cancer community by providing scientific and administrative leadership in the (Cooperative) Groups that design and operate these NCTN clinical trials in the entire broad portfolio of cancers; in particular we are full members with many investigator leaders within NRG Oncology, ECOG-ACRIN and SWOG; and 3) to perform and present hypothesis-based, investigator-led research that benefits future NCTN research. This includes secondary clinical and biorepository translational analyses from NCTN data and pilot studies from our institution. We achieve these aims by assembling an outstanding core of investigators representing all the major cancer specialties (surgical, radiation, medical and diagnostic oncology) and disease sites (hematologic, lung, breast, gastrointestinal, genitourinary, brain, gynecologic and melanoma). We have also developed a robust infrastructure of clinical trials operations in support of the NCTN, including the centralized facilities at Case Western and the hospital-based clinical trials units. They ensure timely activation of, and education about, NCTN trials, accrual enhancement, regulatory management and a high quality of research procedures and data submission. Finally, a major priority is the recruitment, development and mentoring of new Case Western investigators' involvement within the NCTN, including their participation in the Groups' activities such as their semi-annual meetings and committee assignments.

项目摘要 该项目代表了凯斯西储肿瘤学界的全面努力 大学医学院及其三大教学附属医院（克利夫兰大学医院 Clinic和MetroHealth）作为国家临床试验的主要学术参与研究中心参与 网络（NCTN）。由国家癌症研究所（NCI）资助和指导的NCTN是主要的联盟 进行联邦资助的国家多中心临床试验，旨在改善癌症的结果 患者NCTN试验的重点是晚期（III期和相对较大的II期）试验， 这些科学问题通常无法通过其他方法（如单机构研究或 行业公司研究。这些试验的结果通常设定了癌症治疗的护理标准， 美国和世界这包括对罕见癌症和代表性不足人群的临床试验研究。我们 该项目的具体目标是：1）参与具有极高累积量水平的NCTN试验 以及每年约240名新患者的数据生成和提交质量; 2）为NCTN服务 通过在（合作）小组中提供科学和行政领导， 在整个广泛的癌症组合中设计和操作这些NCTN临床试验;特别是我们充满了 NRG肿瘤学、ECOG-ACRIN和SWOG中的许多研究者领导成员;以及3）执行 并提出基于假设的，由研究者领导的研究，有利于未来的NCTN研究。这包括 来自NCTN数据的二级临床和生物储存转化分析以及我们机构的初步研究。 我们通过聚集代表所有主要癌症的杰出研究人员核心来实现这些目标。 专科（外科、放射、内科和诊断肿瘤学）和疾病部位（血液学、肺、乳腺， 胃肠道、泌尿生殖系统、脑、妇科和黑素瘤）。我们还开发了一个强大的 支持NCTN的临床试验运营基础设施，包括Case的集中设施 西方和医院为基础的临床试验单位。他们确保及时启动NCTN并进行相关教育 试验、权责发生制增强、监管管理以及高质量的研究程序和数据 成绩.最后，一个主要的优先事项是招聘，发展和指导新的凯斯西方 调查人员在NCTN内的参与，包括他们参与小组的活动， 半年度会议和委员会任务。