The Biostatistics &Bioinformatics Core will support investigators of the SPORE in Soft Tissue Sarcoma in the computational and statistical aspects of their research efforts, including the design and analysis of clinical trials, laboratory experiments, molecular profiling, and sequencing, as well as integrated genomic analyses. In the clinical trial design phase, a core member will conduct a protocol review with the principal investigator. Based on this review, a statistical section for the protocol will be provided, outlining major scientific objectives, population to be studied, primary and secondary endpoints, experimental design, analysis plans, and a targeted sample size justified in probabilistic terms. At the conclusion of the trial, data analyses will be performed to assess outcomes of the primary and secondary endpoints stated in the protocol. In preclinical studies, core members will assist in the formulation of the experimental design and in the analysis and interpretation of the data at the conclusion of the study. The core will also assist in the large-scale molecular characterization of human sarcoma samples, which involves analyzing RNA expression, microRNA expression, mutations, and DNA copy number changes to identify predictors of tumor characteristics, drug response, and survival. Core members will use two-sample t-tests and Cox proportional hazards models to identify informative features. The different types of molecular data will be integrated and pathway analysis performed to elucidate the pathways that contribute to tumorigenesis and tumor phenotype. Risk prediction tools will be developed using Cox proportional hazards models based on these features.
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