This core supports Projects 1 ? 3 by collecting long-term follow-up data for patients who have had hematopoietic cell transplantation (HCT) or genetically modified T cell therapy at the Seattle Cancer Care Alliance (SCCA), University of Washington (UW) or Seattle Children's Hospital (SCH) under protocols developed at the Fred Hutchinson Cancer Research Center (FHCRC). The services of this core unit address several closely related areas: identification and management of late complications, data and research sample 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. We have developed several mechanisms to support this overall goal. 1. We will collect long-term data focused on survival, therapy-related complications, and health relevant to the clinical research studies sponsored by this grant. This includes the prospective cohort of patients to be enrolled in studies described in Projects 1 ? 3 of this grant application, some of whom will be receiving genetically modified cells and thus follow-up for at least 15 years after treatment is recommended. 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. 2. We will assist investigators in obtaining information and research biospecimens that are not routinely collected but are needed for individual research projects. 3. We will continue to identify barriers that interfere with long-term follow-up of geographically dispersed patients and develop methods to overcome these barriers. 4. We 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 for data collection. The data generated from this core unit will assist project leaders in understanding the long-term efficacy of experimental treatments and identifying late complications after cellular therapy with HCT or genetically modified T cells. Close coordination with the clinical Long-Term Follow-Up Program (LTFU) that provides telemedicine services ensures prompt notification of clinical events. Integrating long-term data collection efforts across the Projects through Core D provides efficient services to support this Research Program.
The Long-Term Follow-Up Unit (LTFU, Core D) supports the Program by providing extended data collection and biospecimen acquisition services to the three Projects. Through a combination of chart review, annual surveys and active contact with participants and providers, Core D is responsible for ensuring that protocol requirements beyond the acute treatment phase (generally 2-3 months) are performed. Core D also interacts closely with Core B, which is responsible for early data collection and data analysis.
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