Therapy-related leukemia is a late complication of treatment with cytotoxic drugs or irradiation. Thereare at least 3 distinctive clinicopathological and cytogenetic syndromes. One of the special features of thisProgram Project is that the 4 individual projects are absolutely dependent upon patient material, since mostof the questions to be addressed arise from the nature of individual patient responses to cytotoxic therapy.That is, why do some patients develop secondary leukemia, and others not? The Patient Access, DataManagement, Statistical Analysis, and Tissue Culture Core (A) has the 4-fold missions of subject recruitmentand informed consent, specimen acquisition and storage, data management and statistical collaboration, andthe generation of Epstein-Barr virus (EBV)-transformed lymphoblastoid cell lines. These functions are criticalto the successful completion of the proposed investigations in each of the 4 projects and necessary tosupport and link together the results that come from the various laboratories. In this way, unique patientresources are shared in the most productive manner. Core A is highly integrated with all 4 projects, and thiscollaborative work has resulted in 21 original articles and abstracts during the past grant period.To provide an orderly access to patient material and to maintain records, we propose to continue ourCore A component to manage these functions as it has for the past 22 years. Core A insures thatappropriate blood and marrow specimens are obtained prospectively for the Cancer Cytogenetics Laboratoryfrom new patients with t-MDS/t-AML, AML de novo, or primary MDS. Research subjects sign InformedConsent forms that are reviewed and approved by the University of Chicago Institutional Review Boardannually. After collection, the clinical specimens are logged in, processed appropriately, and then eitherstored or delivered to the individual projects. Requests from each project PI for specific clinical materials(normal or malignant blood or marrow cells, DNA from buccal swabs, or cell lines from specific patients orfamily members) are received by Core A. Requests from program investigators have the highest priority, butsamples have also been shared with other cancer researchers both at the University of Chicago andelsewhere. Core A also has the responsibility for generating an immortalized, lymphoblastoid cell line fromeach patient with a primary or therapy-related leukemia. Thus, both normal and malignant cells from eachpatient are stored in the Core facility. These resources allow us to study the non-malignant cells andgermline DNA from both living and deceased patients with t-AML. Patient confidentiality is appropriatelyprotected. Data forms are kept secured. Case numbers are assigned; names are not used in publications.Research data are not placed in patients' medical records. Inventories of cells and research data aremaintained in confidential electronic files under password security. The database is automatically backed upon a daily basis; tapes are made and stored off site for further protection. There is no dial-in access to thedatabase, and anti-virus screens are continuously employed on the network. Access is restricted to 4individuals in Core A, each of whom has completed the required course in Human Subjects Protectioncoordinated by the University of Chicago Institutional Review Board.
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