Biomarker Investigations for Clinical Trials

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The Molecular Targets Core (MTC, needs discussion) provides comprehensive biomarker analyses that are integral and critical parts of oncology clinical trials. The Core has exceptional capabilities in high sensitive, very specific, and extremely accurate measurements of investigational biomarkers with most of them cannot be measured or detected in a regular clinical diagnostic lab. The quantitative determination of these biomarkers in clinical specimens provides essential information to demonstrate the effectiveness of the experimental agents in inhibiting their intended targets and in achieving their biological effects in the patients in early phases of clinical trials. In correlative studies with clinical responses, some of the biomarkers may also provide an insight into those that may be predictive of the response in patients on novel or new agents. MTC engages clinical trials as co-investigators responsible for biomarker investigations. It has extensive experiences in designing, developing and implementing biomarker investigations for trials of novel oncology agents. The Core currently supports nearly 40 clinical trials at NCI. It has an in-depth experience in biomarker analysis for clinical studies. MTC can also provide highly sensitive and multiplex testing for intracellular proteins, cytokines, growth factors, and many other biomarkers for all investigators at NCI in collaborative ways or for a fee which is significantly lower than that in the market. The Core is capable of performing biomarker assays in areas including oncology, immunology, and cardiovascular and central nervous systems. In addition to human studies, the Core is further capable of performing biomarker analysis in preclinical animal models including mouse and rat. Thus, the Core has exceptional expertise in both clinical and preclinical biomarker studies covering a wide-range of disciplines. MTC is further unique in developing very high quality assays for new biomarkers and will assist all investigators to develop highly sensitivity assays for clinical studies. This capability allows investigators to develop and customize high quality assays for in vivo biomarker studies at affordable prices.