The research projects conducted by the Oral Cancer Research Center will utilize tissue samples from a common pool of patients. Tissues will be stored in a common tissue bank. This centralization facilitates the provision of common management information and statistical consulting services. Preliminary calculations showed that the projected tissue accrual will yield acceptable statistical power even if only a small fraction of the patients can provide useable data on any given project. Specifically, 300 useable patients out of a total projected accrual of 1,500 would yield a power of at least 80% to detect clinical effects observed in other studies of integrins and proteinases. A computerized data base will be designed, implemented and maintained. The data base will allow tracking of patient demographic and clinical information and information derived from tissue samples. Biostatistical consulting will be provided on an individualized basis to the research projects. The primary endpoint will be disease-free survival, but marker status will also be correlated with clinical stage and other variables of interest. In addition, the results of the individual research projects will be integrated using multivariate statistical techniques. This will allow for the estimation of the simultaneous effect of different markers and may serve to derive risk scores for future clinical use.
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