) The complex polygenic nature and variable penetrance of most genetically-based cancers means that it will be difficult to identify potential modifier genes without access to large numbers of well staged and treated cancer populations and carefully collected age and ethnicity-matched disease free controls. These resources will be critical to gene discovery and gene characterization initiatives, as well as, for the translation of basic science observations into clinically relevant findings. To support these initiatives, Fox Chase is developing a facility dedicated to the collection and distribution of human subject biosamples (i.e., whole blood, plasma, DNA/RNA, and lymphocytes) and supporting personal and family cancer history data. The Biosample Repository Core Facility (BRCF) will operate as part of the Clinical Molecular Genetics Laboratory (CMGL), and will be overseen by an interdivisional Advisory Committee (AC), with day-to-day staff supervision provided by Dr. Andrew K. Godwin. Operations and protocols will be based on those originally implemented by Dr. Godwin, the Director of the CMGL, in support of the Family Risk Assessment Program (FRAP), Gastrointestinal Tumor Risk Assessment Program (GI-TRAP), the Sunbelt Melanoma Trial, and the Ovarian Cancer Clinical Network (OCCN) registry. Individuals attending a clinic at Fox Chase will be invited to contribute a blood sample, complete family history, risk factor and demographic questionnaires, and sign an informed consent. Donated blood samples will be separated into the following components: Lymphocytes will be isolated from half of the blood, divided into multiple aliquots, and cryopreserved in liquid nitrogen for future transformation or nucleic acid preparation. DNA will be isolated from one quarter of donated blood and will be stored frozen at -80 degrees Celsius. The DNA will be quantitated and will be stored in dedicated mechanical freezers at -80 degrees Celsius. The remaining blood will be used for the preparation of plasma and blood spots. Samples, as processed, will be entered into a database. This database will be used to track sample type, quantity, freezer location, and distribution. Available samples (whole blood, plasma, lymphocytes, and DNA/RNA) will be distributed by the BRCF for use in interdivisional AC and IRB approved research projects. Depending on the type and amount of sample requested a fee will be charged to the investigator that is designed to recoup 90 percent of consumable supply costs and 90 percent of administrative supplies. The BRCF will build upon the expertise of Fox Chase investigators in obtaining human biospecimens and the strength of the Population Studies Facility in maintaining large databases. We have extensive experience in recruiting patients into various epidemiologic studies and samples of this type have been collected on over 1,750 patients into various federally funded projects, including 261 colorectal, 358 lung, 747 breast, 320 prostate, and 70 ovarian cancer cases. Dr. Godwin's group has accrued biospecimens from several thousand individuals participating in our high-risk cancer programs. A database system has been developed to support these programs at FCCC, and will also serve the BRCF. This database currently maintains health history, family history, clinical, epidemiologic, socio-demographic, diet, psychosocial, laboratory, and biosample inventory data contributed by over 3,000 high-risk individuals and the cancer and vital status data on over 40,000 of their relatives.
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