Core D will provide logistical, regulatory, and research data management support for all clinical trial projects conducted under this grant application. It will maintain a comprehensive BMT repository database on all patients undergoing allogeneic HSCT, and ensure HIPAA compliant release of clinical outcomes data to researchers for correlation with their laboratory findings. The ultimate objective of this program project application is to understand the pathophysiology of chronic graft-vs.-host disease (GVHD) in humans. The focus of all projects is to develop targeted strategies that can prevent and control cGVHD. Core D will be responsible for the complete and accurate collection of individual patient data for all the clinical studies in this grant. Clinical data on patients collected through core D will be available to investigators in other cores so that they will have clinical correlates for their laboratory observations. Integrated data management is critical for all clinical projects and extend beyond patient care and clinical laboratory functions. Core D will coordinate the proper collection of detailed patient-level data in the BMT repository database, and assure that the highest quality data are available to achieve laboratory and clinical objectives. This core will interact extensively with staff from the Biostatistics Core C who can retrieve data directly from the BMT repository for correlative analyses. Core D will work closely with Core C to provide assistance in study design and analysis for the Projects. The purpose of the Data Management Core D is to provide the following services that will be utilized by all three Projects: 1. To help clinical and laboratory investigators identify the necessary patient-level information for their projects, and to design forms, procedures and databases to capture these data 2. To provide clinical data management for abstraction of individual patient information 3. To provide clinical trials with regulatory binder support and quality control for clinical data 4. To assure patient confidentiality and HIPAA compliance in the release of personal or clinical information from the HSCT repository to investigators who need this data for clinical correlation with their laboratory findings.
All research projects in this application require coordinated clinical data in order to answer their respective scientific questions. It is the responsibility of Core D to provide complete support to the projects for these needs so that collection of patient information is timely, complete, of high quality, and immediately available for analysis.
|Borges, Christopher M; Reichenbach, Dawn K; Kim, Beom Seok et al. (2016) Regulatory T cell expressed MyD88 is critical for prolongation of allograft survival. Transpl Int 29:930-40|
|Armand, Philippe; Kim, Haesook T; Sainvil, Marie-Michele et al. (2016) The addition of sirolimus to the graft-versus-host disease prophylaxis regimen in reduced intensity allogeneic stem cell transplantation for lymphoma: a multicentre randomized trial. Br J Haematol 173:96-104|
|Alho, Ana C; Kim, Haesook T; Chammas, Marie J et al. (2016) Unbalanced recovery of regulatory and effector T cells after allogeneic stem cell transplantation contributes to chronic GVHD. Blood 127:646-57|
|SchÃ¶nle, Anne; Hartl, Frederike A; Mentzel, Jan et al. (2016) Caveolin-1 regulates TCR signal strength and regulatory T-cell differentiation into alloreactive T cells. Blood 127:1930-9|
|Flynn, Ryan; Paz, Katelyn; Du, Jing et al. (2016) Targeted Rho-associated kinase 2 inhibition suppresses murine and human chronic GVHD through a Stat3-dependent mechanism. Blood 127:2144-54|
|Zeiser, Robert; Blazar, Bruce R (2016) Preclinical models of acute and chronic graft-versus-host disease: how predictive are they for a successful clinical translation? Blood 127:3117-26|
|Kim, Haesook T; Zhang, Mei-Jie; Woolfrey, Ann E et al. (2016) Donor and recipient sex in allogeneic stem cell transplantation: what really matters. Haematologica 101:1260-1266|
|Souroullas, George P; Jeck, William R; Parker, Joel S et al. (2016) An oncogenic Ezh2 mutation induces tumors through global redistribution of histone 3 lysine 27 trimethylation. Nat Med 22:632-40|
|Koreth, John; Kim, Haesook T; Jones, Kyle T et al. (2016) Efficacy, durability, and response predictors of low-dose interleukin-2 therapy for chronic graft-versus-host disease. Blood 128:130-7|
|Hirakawa, Masahiro; Matos, Tiago; Liu, Hongye et al. (2016) Low-dose IL-2 selectively activates subsets of CD4(+) Tregs and NK cells. JCI Insight 1:e89278|
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