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 #
5P01CA081403-13
Application #
8378056
Study Section
Special Emphasis Panel (ZCA1-GRB-S)
Project Start
Project End
Budget Start
2012-06-01
Budget End
2013-05-31
Support Year
13
Fiscal Year
2012
Total Cost
$157,048
Indirect Cost
Name
Children's Hospital of Los Angeles
Department
Type
DUNS #
052277936
City
Los Angeles
State
CA
Country
United States
Zip Code
90027
Pinto, Navin; DuBois, Steven G; Marachelian, Araz et al. (2018) Phase I study of vorinostat in combination with isotretinoin in patients with refractory/recurrent neuroblastoma: A new approaches to Neuroblastoma Therapy (NANT) trial. Pediatr Blood Cancer 65:e27023
DuBois, Steven G; Mosse, Yael P; Fox, Elizabeth et al. (2018) Phase II Trial of Alisertib in Combination with Irinotecan and Temozolomide for Patients with Relapsed or Refractory Neuroblastoma. Clin Cancer Res 24:6142-6149
Villablanca, Judith G; Ji, Lingyun; Shapira-Lewinson, Adi et al. (2018) Predictors of response, progression-free survival, and overall survival using NANT Response Criteria (v1.0) in relapsed and refractory high-risk neuroblastoma. Pediatr Blood Cancer 65:e26940
Niemas-Teshiba, Risa; Matsuno, Ryosuke; Wang, Larry L et al. (2018) MYC-family protein overexpression and prominent nucleolar formation represent prognostic indicators and potential therapeutic targets for aggressive high-MKI neuroblastomas: a report from the children's oncology group. Oncotarget 9:6416-6432
Webb, Matthew W; Sun, Jianping; Sheard, Michael A et al. (2018) Colony stimulating factor 1 receptor blockade improves the efficacy of chemotherapy against human neuroblastoma in the absence of T lymphocytes. Int J Cancer 143:1483-1493
Cho, Hwang Eui; Min, H Kang (2017) Analysis of fenretinide and its metabolites in human plasma by liquid chromatography-tandem mass spectrometry and its application to clinical pharmacokinetics. J Pharm Biomed Anal 132:117-124
Zheng, Tina; Ménard, Marie; Weiss, William A (2017) Neuroblastoma Metastases: Leveraging the Avian Neural Crest. Cancer Cell 32:395-397
Erdreich-Epstein, Anat; Singh, Alok R; Joshi, Shweta et al. (2017) Association of high microvessel ?v?3 and low PTEN with poor outcome in stage 3 neuroblastoma: rationale for using first in class dual PI3K/BRD4 inhibitor, SF1126. Oncotarget 8:52193-52210
Marachelian, Araz; Villablanca, Judith G; Liu, Cathy W et al. (2017) Expression of Five Neuroblastoma Genes in Bone Marrow or Blood of Patients with Relapsed/Refractory Neuroblastoma Provides a New Biomarker for Disease and Prognosis. Clin Cancer Res 23:5374-5383
Borriello, Lucia; Nakata, Rie; Sheard, Michael A et al. (2017) Cancer-Associated Fibroblasts Share Characteristics and Protumorigenic Activity with Mesenchymal Stromal Cells. Cancer Res 77:5142-5157

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