Development, review, and conduct of Children's Oncology Group (COG) Clinical Trials

儿童肿瘤学组 (COG) 临床试验的开发、审查和实施

• 批准号: 10567992
• 负责人: JEFFREY S DOME
• 金额: $ 14.24万
• 依托单位: CHILDREN'S RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-20 至 2028-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10567992
• 关键词: Adolescent; Amendment; Award; Bilateral; Biology; Cancer Biology; Cancer Survivor; Caring; Cessation of life; Child; Classification; Clinical Trials; Clinical Trials Cooperative Group; Collaborations; Conduct Clinical Trials; Country; Development; Diagnosis; Discipline; Disease; Enrollment; Fostering; Future; Generations; Histology; Hospitals; Infrastructure; Institution; International; Kidney Neoplasms; Leadership; Malignant - descriptor; Malignant Childhood Neoplasm; Malignant Neoplasms; Malignant childhood renal neoplasm; National Clinical Trials Network; Nephroblastoma; Patients; Pediatric Oncology Group; Phase; Principal Investigator; Publications; Quality of life; Recurrent disease; Research; Rhabdoid Tumor; Science; Site; Specialist; Support Groups; Supportive care; Therapeutic; Therapeutic Trials; Time; United States; clinical practice; clinical trial enrollment; improved; member; novel marker; novel strategies; operation; participant enrollment; protocol development; quality assurance; tumor DNA

Abstract Childhood cancer is the leading cause of disease-related death in children in the United States. The Children’s Oncology Group (COG), one of five clinical trials groups supported by the National Clinical Trials Network (NCTN), brings together more than 10,000 experts in childhood cancer representing diverse disciplines. More than 90% of the approximately 16,000 children and adolescents diagnosed with cancer each year in the United States are cared for at COG member institutions. The COG has nearly 100 clinical trials open, including trials to refine front-line therapy for childhood cancer, study novel approaches to patients with recurrent disease, advance understanding of cancer biology, and improve supportive care and quality of life for cancer survivors. The functioning of COG is dependent upon scientific oversight for protocol development that occurs centrally and oversight of clinical trial conduct that occurs locally at more than 200 member sites. Dr. Jeffrey Dome has been a steady and substantial contributor to the COG ever since its inception over 20 years ago at both the central and local levels. At the groupwide level, his major contribution has been his leadership of the Renal Tumor Committee. From 2006-2016, he served as chair of this committee, which entailed oversight of more than 6,000 patients enrolled on the Biology and Classification Study and four front-line therapeutic trials. He successfully guided the committee through the completion of the first generation of COG studies for childhood kidney cancers, resulting in clinical practice change across the country. He remains involved as an advisor to the current committee chair, member of the AREN1721, AREN1921, and AREN2231 study committees, associate vice-chair for publications and leader of the efforts to foster collaborations with international cooperative groups. Dr. Dome also serves on the COG Executive Committee, which advises the Group Chair on science and operations, and the COG Scientific Council, which reviews all the new concepts and major amendments before they are reviewed by the NCI steering committees. Future directions include opening three new COG renal tumor studies for favorable histology Wilms tumor, malignant rhabdoid tumor and bilateral Wilms tumor as well as furthering the study of novel biomarkers such as circulating tumor DNA. At the local level, Dr. Dome serves as the institutional Principal Investigator for COG studies at Children’s National Hospital, one of the largest and most active COG sites. Between 2018-2020, Children’s National had 379 COG clinical trial enrollments, including 115 phase 1 enrollments and 37 phase 2 enrollments. In 2020, Children’s National was in the 98th percentile of all COG sites for therapeutic enrollments. Future directions include improving the quality assurance and regulatory oversight infrastructure to accommodate the increasing complexity of COG trials. The NCI Research Specialist Award will provide an excellent mechanism to protect Dr. Dome’s time to continue to advance COG science.

摘要 儿童癌症是美国儿童疾病相关死亡的主要原因。儿童 肿瘤学组（COG），国家临床试验网络支持的五个临床试验组之一 （NCTN）汇集了来自不同学科的10，000多名儿童癌症专家。更 在美国，每年约有16，000名儿童和青少年被诊断患有癌症， 各州在COG成员机构得到照顾。COG有近100个临床试验开放，包括试验， 完善儿童癌症的一线治疗，研究治疗复发性疾病患者的新方法，取得进展 了解癌症生物学，改善癌症幸存者的支持性护理和生活质量。的 COG的运作依赖于对集中发生的方案制定的科学监督， 监督在当地200多个成员研究中心进行的临床试验。杰弗里·多姆医生 自20多年前成立以来，在中央和地方政府， 和地方各级。在集团层面，他的主要贡献是领导了肾肿瘤 以马克思从2006年到2016年，他担任该委员会的主席，监督了6000多名 参加生物学和分类研究以及四项一线治疗试验的患者。他成功 指导委员会完成了第一代儿童肾癌COG研究， 导致全国各地的临床实践发生变化。他仍然作为顾问参与目前的 委员会主席，AREN 1721、AREN 1921和AREN 2231研究委员会成员，副主席 他是出版物的负责人，并领导促进与国际合作社团体合作的努力。多姆医生 也是COG执行委员会的成员，该委员会就科学和操作向小组主席提供建议， COG科学理事会，负责在审查所有新概念和主要修正案之前对其进行审查 国家癌症研究所指导委员会未来的方向包括开放三项新的COG肾肿瘤研究， 组织学良好的肾母细胞瘤、恶性横纹肌样瘤和双侧肾母细胞瘤，以及进一步 研究新的生物标志物，如循环肿瘤DNA。在地方一级，Dome博士担任机构 国立儿童医院COG研究的首席研究员，该医院是最大和最活跃的COG之一 网站.在2018-2020年间，儿童国家有379个COG临床试验入组，其中包括115个1期 37例第二阶段入组。在2020年，儿童国家是在所有COG网站的第98百分位 用于治疗注册。未来的方向包括改善质量保证和监管监督 这需要一个新的基础设施来适应日益复杂的COG试验。NCI研究专家奖将 提供了一个很好的机制，以保护Dome博士的时间，继续推进COG科学。