The objective of the projects in this application is to improve the therapeutic results for patients with ALL. The Core provides the biostatistical collaboration that is essential for the proper design, conduct, analysis and reporting of the clinical, basic science and translational research studies. The coordinating center functions provided by this Core are essential for the successful conduct of the multi-center clinical trial, the acquisition and distribution of patient specimens, data computerization and quality control, follow-up of patients on studies of cardiac function and design of translational clinical trials. The Core also provides the acquisition of leukemic specimens which is critical to the success of the basic science components. The projects that involve translational research objectives require access to serial bone marrow and peripheral blood specimens from patients as well as accurate and complete information on the long-term clinical outcomes of these patients.
The specific aims of the Core are: 1) to provide biostatistical collaboration for basic science, translational and clinical research projects;2) to provide a Coordinating Center for protocol management, regulatory reporting, eligibility confirmation, patient registration, sample tracking, and data management for the collection of individual patient clinical data;3) to provide Quality Assurance Office for Clinical Trials (QACT) collaboration to develop and maintain computerized databases, design CRFs, computerize both clinical and research laboratory data and provide reports and data requests to facilitate quality control;4) to collect research specimens and coordinate patient follow-up at DFCI;5) to coordinate the collection of research specimens and follow-up data from consortia centers;6) to ensure protocol compliance and accuracy of submitted data from consortia centers by conducting regular on-site data audits of DFCI and consortia members;7) to provide computing resources for data processing, report generation, and statistical analyses;8) to provide web-based communication for study team and consortia members with secured access, and a general access website for patient education;9) to coordinate functions of the Data Monitoring Committee.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Research Program Projects (P01)
Project #
5P01CA068484-15
Application #
8125021
Study Section
Subcommittee G - Education (NCI)
Project Start
Project End
2013-04-30
Budget Start
2010-05-01
Budget End
2011-04-30
Support Year
15
Fiscal Year
2010
Total Cost
$581,052
Indirect Cost
Name
Dana-Farber Cancer Institute
Department
Type
DUNS #
076580745
City
Boston
State
MA
Country
United States
Zip Code
02215
Bansal, Neha; Barach, Paul; Amdani, Shahnawaz M et al. (2018) When is early septal myectomy in children with hypertrophic cardiomyopathy justified? Transl Pediatr 7:362-366
Mansour, Marc R; He, Shuning; Li, Zhaodong et al. (2018) JDP2: An oncogenic bZIP transcription factor in T cell acute lymphoblastic leukemia. J Exp Med 215:1929-1945
Lipshultz, Steven E (2018) Letter by Lipshultz Regarding Article, ""Anthracycline Cardiotoxicity: Worrisome Enough to Have You Quaking?"" Circ Res 122:e62-e63
Temple, Jennifer L; Bernard, Christophe; Lipshultz, Steven E et al. (2017) The Safety of Ingested Caffeine: A Comprehensive Review. Front Psychiatry 8:80
Rahman, Sunniyat; Magnussen, Michael; León, Theresa E et al. (2017) Activation of the LMO2 oncogene through a somatically acquired neomorphic promoter in T-cell acute lymphoblastic leukemia. Blood 129:3221-3226
Hutchins, Kelley K; Siddeek, Hani; Franco, Vivian I et al. (2017) Prevention of cardiotoxicity among survivors of childhood cancer. Br J Clin Pharmacol 83:455-465
Bona, Kira; Blonquist, Traci M; Neuberg, Donna S et al. (2016) Impact of Socioeconomic Status on Timing of Relapse and Overall Survival for Children Treated on Dana-Farber Cancer Institute ALL Consortium Protocols (2000-2010). Pediatr Blood Cancer 63:1012-8
Seftel, Matthew D; Neuberg, Donna; Zhang, Mei-Jie et al. (2016) Pediatric-inspired therapy compared to allografting for Philadelphia chromosome-negative adult ALL in first complete remission. Am J Hematol 91:322-9
Fraser, Raphael André; Lipsitz, Stuart R; Sinha, Debajyoti et al. (2016) Approximate median regression for complex survey data with skewed response. Biometrics 72:1336-1347
Lipshultz, Steven E; Anderson, Lynn M; Miller, Tracie L et al. (2016) Impaired mitochondrial function is abrogated by dexrazoxane in doxorubicin-treated childhood acute lymphoblastic leukemia survivors. Cancer 122:946-53

Showing the most recent 10 out of 214 publications