Analytical will serve as a collection and distribution point for blood samples, DMA, original clinical pathology slides, and colorectal polyp tissue blocks. It will provide a resource and service for carrying out the laboratory analyses proposed in this application. We will develop appropriate sample collection, tracking, storage, and preparation procedures for all biologic samples collected during the course of this proposal. It will develop and optimize methods of measuring the laboratory research endpoints. Analytical will be responsible for the collection, logging, processing, distribution, and tracking of all tissues and samples. Endpoints to be analyzed include blood levels of the treatment drugs, celecoxib and selenium, and COX-2 expression in colorectal polyps. Analytical will oversee and coordinate the collection and processing of all samples related to this Program Project at the various participating hospitals and clinics Furthermore, we will be responsible for the training of personnel involved in the collection and processing of study samples. We will manage the pathology review of all polyp tissue included within this proposal. It will perform work closely with Biometry to provide data for reporting and interpretation. Quality assurance and quality control procedures will continue to be developed in collaboration with Biometry for sample acquisition, processing, and analysis procedures included in each of the clinical projects. Genotyping will support the genotyping needs. We will work with the leaders and co-leaders in testing the hypothesis that genetic polymorphisms (1) play a role in the response of individuals to celecoxib and/or selenium treatment and (2) confer increased susceptibility to advanced and/or recurrent colorectal adenomas and colorectal neoplasia. The goals will be achieved through the development and design of assays against both known functional polymorphisms and yet to be identified functional polymorphisms via haplotype analysis. We will efficiently track DMA samples, provide quality control and assurance, perform genetic analyses, and provide data management of the genotyping databases.
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