The Pathology Core Facility (PCF) is a centralized, comprehensive facility that provides professional expertise in pathology and human tissue-based studies and is specifically dedicated to the needs ofthe Cancer Center research community. The PCF has three main components: research histology, specimen procurement and protocol review. The research histology is composed of three units: routine histology, immunohistochemistry and molecular testing. This includes processing of fixed and frozen tissues, construction of hypothesis driven tissue microarrays, newly improved methods for TMA mapping and creation, sophisticated processes for the extraction of analytes such as RNA and DNA from samples, matched to end-point assay techniques. The research histology section also designs and validates the analytical assays, which include antibody selection and optimization for immunohistochemistry, a newly incorporated in situ hybridization for RNA and DNA with chromogenic and fluorescent detection. Adjoining to the research histology is microscopy, which provides pathologic verification of diagnoses, and quantitative interpretation of results, based on microscopic evaluation, including a new high-throughput digital slide scanner. An annotation and scribing software (Collibio?) allows for distant review, retention of data with image, and conferencing. The biobanking component ofthe PCF has two main functions: human tissue procurement, and quality assurance and protection of research subjects. The tissue procurement section serves to obtain, process, store and distribute characterized neoplastic and benign human tissue. Specimens are not only procured for specific protocols and laboratory projects, but also there is an organized systematic effort for generalized procurement and storage for short and long-term cancer research. PCF maintains a universal IRB consent for procurement of all specimen types. As a member of ISBER and NCI Group Banking Committee, the PCF uses new information, ideas, technology, and regulations in further developing a non-renewable high quality biospecimens resource to meet all aspects of cancer research. Lastly, the PCF reviews all clinical protocols which involve human tissue specimens. The PCF is CAP-accredited, CLIA high-complexity certified, and has the capability to serve integral marker studies, which require biomarker-based treatment arm assignment. The PCF staff are members of institutional review committees, and in this manner provide input and oversight ofthe clinical trial protocol design, and the specifics of tissue release of retrospective specimens. These activities allow for incorporation of pathology-specific competencies into the design and conduct of translational studies, and integrate the PCF into multidisciplinary teams that serves the entire Cancer Center research community. In addition, the PCF also runs the NCI funded ECOG-ACRIN Pathology Coordinating Office - Reference Laboratory, which serves as the centralized center for processing and distribution of biospecimens obtained from patients enrolled in ECOG and intergroup clinical trials.
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