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中文摘要
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核心F:长期随访。该核心通过收集以下项目的长期跟踪数据来支持项目1-6 在西雅图癌症护理联盟接受过造血细胞移植的患者 华盛顿医疗中心或儿童医院和地区医疗中心制定的协议 在弗雷德·哈钦森癌症研究中心,作为由该组织赞助的临床研究的一部分 程序。通过核心F提供的数据需要用于各种极其重要的目的 该方案中的项目:1)捕获长期结果,包括慢性移植物抗宿主病的发生, 感染、复发或进展性恶性肿瘤、继发性恶性肿瘤和其他预期的晚期 并发症,以及参加前瞻性研究试验的患者的最后接触和死亡日期, 2)捕获未参加前瞻性研究的患者的类似观察数据,用于 回溯性研究,3)获取用于计划新的临床试验的观察数据,4) 捕获存活信息,以确定以前未发现的迟发效应。各种机制 将用于支持这些目标。 A)我们将继续收集长期数据,重点是存活率、与治疗有关的并发症、健康和 与此拨款资助的临床研究相关的健康相关生活质量。这些数据 关注目前正在接受先前研究的随访的患者的回顾队列 参加本拨款项目1-6所述研究的预期患者队列 申请。为此,已经建立了一个系统来跟踪和保持与患者的联系 以及推荐医生,以便可以在治疗后的特定时间点收集数据。 B)我们将继续协助调查人员获取个人特别需要的长期数据 研究项目。 C)我们将继续评估在数据收集和数据库管理方面采用的方法, 找出干扰长期随访的障碍,并探索新技术来改善 数据收集的效率和可靠性以及数据的有效性和实用性。 与公共卫生的相关性:这一核心单位产生的数据将帮助项目负责人 接受过血液或骨髓细胞移植的患者的晚期并发症的鉴定 治疗白血病、淋巴瘤、骨髓瘤等相关疾病。数据也将提供依据 对于关于晚期并发症风险因素的假设驱动的研究,导致晚期并发症的机制 并发症,以及预防和管理晚期并发症的新方法的发展 在癌症幸存者中。
英文摘要
Core F: Long-Term Follow-Up. This core supports Projects 1- 6 by collecting long-term follow-up data for patients who have had hematopoietic cell transplantation 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. The data provided through Core F are required for a variety of critically important purposes by projects in this program: 1) capture of longer-term outcomes, including the occurrence of chronic GVHD, infections, recurrent or progressive malignancy, secondary malignancy and other anticipated late complications, as well as dates of last contact and death for patients enrolled in prospective research trials, 2) capture of similar observational data for patients not enrolled in prospective studies, to be used for retrospective studies, 3) capture of observational data to be used for planning new clinical trials, and 4) capture of survivorship information to identify previously unrecognized late effects. A variety of mechanisms will be used to support these goals. a) We 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. These data concern the retrospective cohort of patients currently in follow-up from previous studies and the prospective cohort of patients to be enrolled .in studies described in Projects 1 - 6 of this grant application. 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)We will continue to assist investigators in obtaining long-term data specifically needed for individual research projects. c) We will continue to evaluate the methods employed in data collection and database management, identify barriers that interfere with long-term follow-up, and explore new technology to improve the efficiency and reliability of data collection and the validity and utility of the data. Relevance to Public Health: The data generated from this core unit will assist project leaders in the identification of late complications In patients who have had blood or marrow cell transplantation for treatment of leukemia, lymphoma, myeloma and other related disorders. The data will also provide the basis for hypothesis-driven research concerning risk factors for late complications, the mechanisms leading to late complications, and the development of new approaches for preventing and managing late complications among cancer survivors.
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Protocol Review and Monitoring System
Clinical Protocol and Data Management
Patient Enrollment, Specimen and Data Management, and Biostatistics
Prevention and Treatment of Graft-Versus-Host Disease