Core A is responsible for the identification and enrollment of every adult patient referred to the SitemanCancer Center with newly diagnosed and relapsed acute myeloid leukemia (AML) and MyelodysplasticSyndrome (MDS). The clinical and pathologic material from these patients are entered into databases thatare required for the execution of this program project. Additionally, clinical, pathologic and therapeuticinformation are essential for determining the clinical relevance of a newly identified genetic mutation. TheClinical Database Core (Core A) was established in 2002 to serve as a platform for the investigation ofgenetic mutations associated with the pathogenesis of MDS and acute myeloid leukemia, and has twoSpecific Aims, as follows:
Specific Aim 1 : We will prospectively identify and enroll on study all patients with newly diagnosedor relapsed AML and MDS referred to Washington University Siteman Cancer Center.Since its establishment, Core A has been responsible for banking tissue from 167 MDS and 387 AMLpatients (-98% accrual) according to an IRB approved Tissue Acquisition protocol. From these 554 patients,bone marrow was collected from 515 (93%), blood from 517 (93%), serum from 455 (82%), skin from 495(89%), and oral mucosa cells from 376 (68%), as of 4/1/07. Additional tumor specimens were collected from28 of the AML patients at the time of relapse/progression; additional tumor specimens were collected from13 of the MDS patients at the time of progression to AML. Since January of 2007, 43 patients have beenreconsented so that their samples can be used for the whole genome resequencing studies of Project 1.
Specific Aim 2 : We will establish a comprehensive clinical leukemia database that will captureepidemiological data, disease-related characteristics, prognostic factors, therapeutic information,and outcomes from all newly diagnosed and relapsed AML and MDS patients referred to SitemanCancer Center. Along with genomic data obtained on specimens collected from these patients and stored inthe Specimen Acquisition and Expression Profiling Core (Core B), this comprehensive database will providethe Project 2 and the Biostatistics Core (Core C) with critical elements to test and validate the prognosticsignificance of any given mutation. Comprehensive disease-specific and outcomes data has been compiledon every patient in a de-identified database. This effort has facilitated the compilation of a well defined anduniform set of 94 samples from patients with de novo AML (primarily MO-M4) with >30% blasts, <2 clonalcytogenetic abnormalities, and with adequate tumor and germline DMA specimens for DMA sequenceanalysis, array-based genomic studies to define copy number changes and uniparental disomy, and arraybasedgene expression profiling.
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