We have established a Consortium Tissue Core to process, store, and distribute samples from patients withChronic Lymphocytic Leukemia. One of the aims of this proposal is to continue to serve as a repository forall CLL samples from patients diagnosed and collected at the participating CRC clinical sites. Theprocessing, storage, and distribution of each sample will be performed according to established standardoperating procedures in accordance with HIPAA regulations. The Tissue Core will also perform a basic setof assays on all viably stored CLL samples from each patient upon initial receipt. These tests will include:immunophenotyping to determine the surface antigen phenotype, ZAP-70 expression, and determination ofthe expressed immunoglobulin heavy chain gene (IgVH) mutational status. Testing for Minimal ResidualDisease (MRD), soluble CD20/CD52 (rituximab/alemtuzumab), and B CLL turnover rates will be performedon specific CLL samples enrolled in clinical trials during follow-up and pre & post therapy as needed. Inaddition, the serial samples of specific CLL patients will be characterized according to their surface antigenphenotype by multiparameter flow cytometric analysis. This will allow the CRC investigators to examine forlongitudinal changes in the leukemia cell's genotype, biochemistry, and/or immunologic phenotype andcorrelate these data to clinical outcome. The Tissue Core will seek to standardize interphase Fluorescencein situ Hybridization (FISH) studies by distributing specific characterized CLL samples to the participatingCRC cytogenetics sites at which FISH analysis will be conducted. This validation will provide innovative andaccurate interphase FISH studies for CRC clinical trials and research investigators. The Tissue Core willalso collect, process, and validate specimens from affected family members with CLL for targeted geneticstudies performed by CRC investigators. Finally, the Tissue Core will distribute specific characterizedsamples as requested by CRC investigators for hypothesis driven studies. This trafficking of characterizedCLL samples, with their associated clinical and demographic data, will enable and facilitate the developmentof new CLL therapies.
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