The Biostatistics Core will provide the statistical support for clinical, animal, tissue-based, and cell line investigations in pediatric neuroblastoma supported by this Program Project Grant (PPG). Sound design and statistical input in the planning, conduct, and interpretation of experiments promote the two aspects of translational research: (1) rapid incorporation of significant laboratory findings into the development of data-based therapeutic clinical studies and (2) the development of questions and hypotheses based on clinical findings which can be further investigated in the laboratory. With this in mind, there are three aims of the Biostatistics Core. 1. Provide statistical expertise in the early planning and in the experimental design of laboratory and clinical research a. in vitro experiments (e.g. cell line drug response) b. in vivo experiments (e.g. mouse clinical trials) c. Studies/experiments using specimens from patients (e.g. Affy HuEx) d. NANT Clinical Trials (early phase clinical trials) 2. Provide formal statistical analyses for these experiments and studies 3. Oversee data collection, study progress, data quality control a. With Project 4. oversee the further development and maintenance of the NANT Phase l/ll database.

Public Health Relevance

Statistical collaboration and formal statistical design considerations are essential to the planning of experiments {in vitro and in vivo), clinical trials, and observational studies. Appropriate design is necessary to ensure efficient, feasible studies that will yield meaningful results;appropriate (statistical) analysis, ensures that results are correctly interpreted, and maximizes the information learned.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Research Program Projects (P01)
Project #
5P01CA081403-14
Application #
8506991
Study Section
Special Emphasis Panel (ZCA1-GRB-S)
Project Start
Project End
Budget Start
2013-06-01
Budget End
2014-05-31
Support Year
14
Fiscal Year
2013
Total Cost
$248,617
Indirect Cost
$43,132
Name
Children's Hospital of Los Angeles
Department
Type
DUNS #
052277936
City
Los Angeles
State
CA
Country
United States
Zip Code
90027
DuBois, Steven G; Marachelian, Araz; Fox, Elizabeth et al. (2016) Phase I Study of the Aurora A Kinase Inhibitor Alisertib in Combination With Irinotecan and Temozolomide for Patients With Relapsed or Refractory Neuroblastoma: A NANT (New Approaches to Neuroblastoma Therapy) Trial. J Clin Oncol 34:1368-75
Trieu, Megan; DuBois, Steven G; Pon, Elizabeth et al. (2016) Impact of Whole-Body Radiation Dose on Response and Toxicity in Patients With Neuroblastoma After Therapy With 131 I-Metaiodobenzylguanidine (MIBG). Pediatr Blood Cancer 63:436-42
DuBois, Steven G; Groshen, Susan; Park, Julie R et al. (2015) Phase I Study of Vorinostat as a Radiation Sensitizer with 131I-Metaiodobenzylguanidine (131I-MIBG) for Patients with Relapsed or Refractory Neuroblastoma. Clin Cancer Res 21:2715-21
Chen, Justin; Hackett, Christopher S; Zhang, Shile et al. (2015) The genetics of splicing in neuroblastoma. Cancer Discov 5:380-95
Yanik, Gregory A; Villablanca, Judith G; Maris, John M et al. (2015) 131I-metaiodobenzylguanidine with intensive chemotherapy and autologous stem cell transplantation for high-risk neuroblastoma. A new approaches to neuroblastoma therapy (NANT) phase II study. Biol Blood Marrow Transplant 21:673-81
HaDuong, Josephine H; Blavier, Laurence; Baniwal, Sanjeev K et al. (2015) Interaction between bone marrow stromal cells and neuroblastoma cells leads to a VEGFA-mediated osteoblastogenesis. Int J Cancer 137:797-809
Wang, L L; Teshiba, R; Ikegaki, N et al. (2015) Augmented expression of MYC and/or MYCN protein defines highly aggressive MYC-driven neuroblastoma: a Children's Oncology Group study. Br J Cancer 113:57-63
DuBois, S G; Allen, S; Bent, M et al. (2015) Phase I/II study of (131)I-MIBG with vincristine and 5 days of irinotecan for advanced neuroblastoma. Br J Cancer 112:644-9
Cage, Tene Aneka; Chanthery, Yvan; Chesler, Louis et al. (2015) Downregulation of MYCN through PI3K Inhibition in Mouse Models of Pediatric Neural Cancer. Front Oncol 5:111
Huang, Shih-ying; Bolch, Wesley E; Lee, Choonsik et al. (2015) Patient-specific dosimetry using pretherapy [¹²⁴I]m-iodobenzylguanidine ([¹²⁴I]mIBG) dynamic PET/CT imaging before [¹³¹I]mIBG targeted radionuclide therapy for neuroblastoma. Mol Imaging Biol 17:284-94

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