The Clinical Molecular Profiling Core (CMPC) is a collaborative core that seeks to go beyond the common service paradigm of other laboratory cores. The expertise of its personnel allows involvement from the start of a project, such as the protocol development, through performance of the assay and biostatistical analyses. Currently, our main function is to support clinical trials at the National Cancer Institute (NCI) and to that end we have collaborations with many of the branches in the Center for Cancer Research (CCR/NCI) and sister centers in the NCI. The status of these collaborations range from preliminary discussions through protocol development, accrual and analysis, and completion to publication; for those that are completed, we look forward to being involved in follow up studies. Many of the studies are clinical trials testing or identifying drugs for early phase clinical trials. These include studies such as: Phase 1 study of CaboNivo or CaboNivoIp in Metastatic Urothelial and Genitourinary Cancer and A Phase II Trial of Mutation-Targeted Therapy with Sunitinib or Everolimus in Patients with Neuroendocrine tumors. In the past we have supported Molecular profiling and targeted therapy for advanced thoracic malignancies: a biomarker-derived, multiarm, multihistology phase II basket trial and a trial in Functionally defined therapeutic targets in diffuse intrinsic pontine glioma. However, other investigations are more focused on understanding the underlying pathology of specific diseases and are not directly testing a therapy. In the last year these studies included publications (4 of 8) on: Molecular Subtypes of KIT/PDGFRA Wild-Type Gastrointestinal Stromal Tumors: A Report from the National Institutes of Health Gastrointestinal Stromal Tumor Clinic. (Boikos et al., JAMA Oncol. 2016); Neuroendocrine Tumor of the Pancreas as a Manifestation of Cowden Syndrome: A Case Report. (Neychev et al., J Clin Endocrinol Metab. 2016); Impact of Telomere Length on Survival in Classic and Variant Hairy Cell Leukemia. (Arons et al., Leuk Res. 2015); and An Integrated Prognostic Classifier for Stage I Lung Adenocarcinoma Based on mRNA, microRNA, and DNA Methylation Biomarkers. (Robles et al., J Thorac Oncol. 2015). Significantly, resources have been devoted to actualizing clinical exome sequencing using Illumina next-generation sequencing in the context of our CLIA [Clinical Laboratory Improvement Amendments] laboratory. To support these studies, the CMPC has expertise in many molecular technologies for the analysis of DNA and RNA from human specimens. Other state of the art assays utilized in the CMPC are a wide range of advanced platforms that include: DNA sequencing (Sanger and next-generation sequencing), mRNA expression analysis (microarray, real-time PCR, bead-based), epigenomic methylation (microarray and pyrosequencing), array comparative genomic hybridization (microarray), and telomere length assays. Importantly, the CMPC provides full bioinformatics support for all these assays.
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