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Contents
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Introduction to the Clinical Molecular Profiling Core
Figure 1. High-resolution array-based comparative
genomic hybridization (array-CGH) of a breast cancer. Chromosome 8 is illustrated
with gains on the right and losses on the left. Note the complex pattern with
precisely defined boundaries of copy number change. This type of data, which can
be generated rapidly from small, clinically practical samples, might be useful
for tumor classification and gene discovery.
ncologists caring for patients are acutely aware that each patient is an individual and that each tumor has its characteristic biological properties. These differences may not be important if there are only a few options for therapy, but now, in the age of targeted therapies with numerous new agents appearing in the clinic and many more on the horizon, matching the right treatment to the right patient appears increasingly important. Identifying the biological differences between tumors and defining the mechanisms by which theses features affect clinical outcomes are key components of contemporary clinical research. Biological data linked to clinical trials can enhance the value of those studies as CCR investigators work toward the rational implementation of targeted therapy. The Clinical Molecular Profiling Core has been created to facilitate biological data collection on every tumor entered into a CCR trial. Fortunately, technologies for the molecular profiling of cancer have advanced substantially. It is now possible to obtain a tremendous amount of information from clinical specimens. The goal of the Clinical Molecular Profiling Core will be to provide every CCR clinical investigator with access to a suite of technologies for the characterization of biospecimens collected in the course of clinical trials. Because genetic and epigenetic changes are fundamental to cancer progression, the Core will focus primarily on genomic technologies: gene expression profiling, comparative genomic hybridization, high-density single nucleotide polymorphism (SNP) analysis, DNA sequencing, and related assays. Access to the Core will spare clinical investigators the need to develop technical expertise in these areas. Efforts are being made to offer a range of technologies to accommodate the realities of specimen collection in a variety of clinical situations. Specimen tracking, handling, and assays will follow standard procedures to maximize data reliability and maintain compliance with NCI specimen-collection guidelines. Core scientific staff will be available to consult with clinical investigators about assay selection, study design, and specimen requirements. Core staff will also support data analysis and interpretation. This is an exciting period in the history of cancer research, in large part because there is a sense that advances in cancer biology are leading to real progress in cancer therapy. We trust that the Clinical Molecular Profiling Core will create opportunities for CCR clinical investigators to bring these technologies to bear on their efforts to develop more effective therapies for their patients.
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