Colorectal cancer is the third most commonly diagnosed cancer and the second leading cause of cancer-related deaths in the United States and the developed world. Despite the availability of proven effective preventive screening tools, less than 50% of average risk Americans in the high-risk age group (over 50) have been screened. After age, personal and family history of colon and/or polyps is the most common risk factor. Following APC mutation, the mechanisms of adenoma formation and progression are proving complex. The integrated approach of the 4 projects addresses these issues from several different perspectives. The Biostatistics Core (Core D) provides statistical expertise for all University of Utah Colon Cancer PPG projects, cores, investigators and participants. Core members collaborate in 1) the design, implementation, and analysis of laboratory and clinical research studies, and 2) the development and application of new statistical methods and analysis algorithms to address problems relevant to PPG projects. Core staff will function as collaborative members of research teams to jointly develop design and analysis plans to address research questions. Functions provided by the Biostatistics Core include development of experimental designs, participation in study implementation, data quality monitoring, statistical analysis and interpretation of findings, and collaboration on presentation of results. To achieve these functions, the Core director and biostatisticians collaborate with project investigators, and are in regular contact with the project and core leaders. The primary objectives of the Biostatistics Core are 1) To provide study design and review of all laboratory, animal and clinical studies including feasibility assessment, power analysis and sample size calculation. 2) To collaborate in projects'data analysis, interpretation of results, and the writing of final study reports and manuscripts. 3) To work with the Analytical Core (Core B) and Clinical Core (Core C) in their activities to ensure data quality and timely data capture. 4) To develop and evaluate statistical methods for experimental design and data analysis as required for PPG projects. The Biostatistics Core supports all four Colon Cancer PPG projects at the University of Utah.

Public Health Relevance

Our long-term goal is to further the development of new preventive measures for colon adenoma formation by understanding the earliest cellular dysfunction following APC mutation. The Biostatistics Core suppports this goal by providing statistical expertise in study design, data analysis, and interpretation of results for all projects and cores associated with the University of Utah Colon Cancer PPG.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Research Program Projects (P01)
Project #
5P01CA073992-13
Application #
8378608
Study Section
Special Emphasis Panel (ZCA1-RPRB-7)
Project Start
Project End
Budget Start
2012-03-01
Budget End
2013-02-28
Support Year
13
Fiscal Year
2012
Total Cost
$166,112
Indirect Cost
$90,025
Name
University of Utah
Department
Type
DUNS #
009095365
City
Salt Lake City
State
UT
Country
United States
Zip Code
84112
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Samadder, N Jewel; Neklason, Deborah W; Boucher, Kenneth M et al. (2016) Effect of Sulindac and Erlotinib vs Placebo on Duodenal Neoplasia in Familial Adenomatous Polyposis: A Randomized Clinical Trial. JAMA 315:1266-75
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