Core B (Biorepository/Biostatistics). Core B will service Projects 1, 2, and 3 by providing clinically annotated human glioma tissue and serum samples and biostatistics support to the P01.
In Aim #1 (Biorepository), tissue and sera samples from newly diagnosed glioma patients, recurrent glioma patients an biopsy proven cases of radiation necrosis will be prospectively collected and designated for analysis. This will include the initial and longitudinal collection of sera and tumor tissue for a year following diagnosis. Overall, seven collaborating institutions have committed their support to this aim's biospecimen collections.Sample collection, annotation, storage, and analysis between participating sites will be coordinated using a web based sample tracking tool (GBCWEB) that has been created. In addition, the repository will receive and distribute biospecimen samples from non POl collaborating clinical trials that have already tested a specific molecularly targeted therapeutic (e.g. anti-EGFRvlll vaccination-Dr. Sampson, anti-PDGFR inhibition-Dr. Kesari;RTOG Iressa-Dr. Chakravarti). In collaborative fashion. Projects 2 and 3, Core B will test whether the molecular targets of these therapies can be monitored using microvesicle RNA technology. Finally, using the Biostatics and clinical expertise within the core, the Biorepository will generate appropriately powered patient sample sets for testing clinical hypotheses such as whether serum microvesicle RNA signatures of Temozolamide or bevacizamab chemotherapy be determined radiation necrosis versus recurrent glioma be distinguished using microvesicle RNA microarray analysis or whether serum microvesicle tumor specific mutation detection reflects treatment effect or prognosis.
In Aim #2 (Biostatistics), the Core will provide Biostatistical support (Dr. Messer) to all projects and Core C in validating sensitivity and specificity of assays and in appropriate study design.
Glioma contributes the 2nd largest years of life lost to cancer, affecting a young population. It is highly lethal with low duration of survival after diagnosis. The ability to monitor and tailor therapeutics using a serum microvesicle based approach would be a significant advance.
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