Core--Long-Term Follow-Up and Chronic GVHD

核心--长期随访与慢性GVHD

• 批准号: 7304878
• 负责人: PAUL J MARTIN
• 金额: $ 18.33万
• 依托单位: FRED HUTCHINSON CANCER RESEARCH CENTER
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-08-15 至 2011-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7304878
• 关键词: biomedical facility; clinical research; data collection; data quality /integrity; graft versus host disease; hematopoietic stem cells; hematopoietic tissue transplantation; human subject; longitudinal human study; method development; patient /disease registry; postoperative complications; stem cell transplantation

This Core collects long-term follow-up data for patients who have had hematopoietic cell transplantation (HCT) at the Seattle Cancer Care Alliance, University of Washington Medical Center or Children's Hospital and Regional Medical Center under protocols developed at the Fred Hutchinson Cancer Research Center as part of clinical research studies sponsored by this program. With this focus in mind, the services of this core unit address several closely related areas: identification and management of late complications, data collection, database assembly and evaluation of the efficiency, accuracy, quality and utility of the data collection and the system in which the data are stored. Chronic graftversus- host disease and late infections are prominent among the complications to be followed with support from this core unit. A variety of mechanisms have been developed to support this overall goal. a) This Core will continue to collect long-term data focused on survival, therapy-related complications, health and health-related quality of life relevant to the clinical research studies sponsored by this grant. This includes the retrospective cohort of patients currently in follow-up from previous studies and the prospective cohort of patients to be enrolled in studies. For this purpose, a system has been established to track and maintain contact with patients and referring physicians so that data can be collected at specified time points after treatment. b) This Core will continue to assist investigators in obtaining information that is not routinely collected when needed for individual research projects. c) This Core will continue to identify barriers that interfere with long-term follow-up and develop methods that could improve participation. d) This Core will continue to evaluate the research methods employed in data collection and database management, including the efficiency, reliability, validity and utility of the instruments used in the LTFU core. The data generated from this core unit will assist project leaders in the identification of late complications after HCT and help in the development of methods for improved management or prevention of these complications. The data could help to generate hypothesis-driven research concerning risk factors for late complications, the pathophysiology leading to late complications, and the development of methods for preventing late complications after HCT.

该核心收集患有以下疾病的患者的长期随访数据 华盛顿大学西雅图癌症治疗联盟的造血细胞移植 (HCT) 根据弗雷德制定的协议的医疗中心或儿童医院和地区医疗中心 哈钦森癌症研究中心作为该计划赞助的临床研究的一部分。和 考虑到这一重点，该核心单位的服务涉及几个密切相关的领域：识别和 晚期并发症的管理、数据收集、数据库组装和效率评估， 数据收集和数据存储系统的准确性、质量和实用性。慢性移植物抗- 宿主疾病和晚期感染是需要支持的并发症中最突出的 来自这个核心单元。已经开发了多种机制来支持这一总体目标。 a) 该核心将继续收集长期数据，重点关注生存、治疗相关并发症、 与本次资助的临床研究相关的健康和健康相关的生活质量 授予。这包括目前正在进行先前研究随访的患者回顾性队列 以及将参加研究的前瞻性患者队列。为此，建立了一个系统来跟踪和保持联系 患者和转诊医生，以便可以在治疗后的指定时间点收集数据 治疗。 b) 该核心将继续协助调查人员获取不定期收集的信息 当个别研究项目需要时。 c) 该核心将继续识别干扰长期后续行动的障碍并制定方法 这可以提高参与度。 d) 该核心将继续评估数据收集和数据库中采用的研究方法 管理，包括所用工具的效率、可靠性、有效性和实用性 LTFU 核心。 该核心单元生成的数据将帮助项目负责人识别晚期并发症 HCT 后并帮助开发改善管理或预防这些问题的方法 并发症。这些数据有助于针对晚期风险因素进行假设驱动的研究 并发症、导致晚期并发症的病理生理学以及治疗方法的开发 预防 HCT 后的晚期并发症。