Molecular Profiling of Clinical Specimens

临床分子分析核心（CMPC）是一个协作核心，旨在超越其他核心的共同服务范式。专业人员的专业知识使我们能够从项目开始就参与其中，例如方案开发，以及检测和生物统计分析的执行。目前，我们的主要职能是支持国家癌症研究所（NCI）的临床试验，为此，我们与癌症研究中心（CCR）和临床中心的许多分支机构合作。超过50多个临床合作涉及CCR的许多分支，如医学肿瘤学，皮肤病学，泌尿肿瘤学，病理学实验室，儿科肿瘤学，代谢和放射肿瘤学。这些合作的状况从初步讨论到协议制定、应计和分析以及完成。对于那些已经完成的，我们期待着参与后续研究。许多研究是临床试验，测试I期或II期药物或新的联合疗法。这些研究包括诸如索拉非尼和贝伐单抗在治疗患有难治性、转移性或不可切除的实体瘤的患者中的研究，Pan-HER抑制剂PF-00299804在非小细胞肺癌中的研究，R1507的II期研究的全组生物学和建库研究，“贝利司他在患有复发性或转移性实体瘤的患者中的II期研究，既往接受过含铂化疗的不可切除的胸腺瘤或胸腺癌”，凡德他尼的I/II期试验（ZD 6474，Zactima）在患有遗传性甲状腺髓样癌的儿童和青少年中的应用，确定儿童脑桥胶质瘤的基因组畸变，一项AKT抑制剂磷酸曲西立滨一水合物和厄洛替尼（Tarceva）在表皮生长因子受体（EGFR）抑制剂耐药或初治的晚期肺癌或其他实体瘤受试者中的I期研究，以及一项ZD 6474的靶向I期试验（凡德他尼; AZCTIMA）联合蛋白酶体抑制剂硼替佐米（万珂）治疗成人实体瘤，重点是遗传性或散发性、局部晚期或转移性甲状腺髓样癌（MTC）。然而，其他研究更侧重于了解特定疾病的潜在病理学，而不是直接测试疗法。这些研究包括暴露于紫外线辐射的成人和儿童的基因表达谱和光毒性，接受干细胞移植的慢性移植物抗宿主病患者的临床评价和实验室研究，遗传性泌尿系统恶性疾病的临床表现和分子基础，从活检证实或疑似恶性疾病患者中收集血清和组织样本，滤泡性淋巴瘤的大规模甲基化分析，小细胞肺癌的分子特征分析，胸腺瘤亚群的分子特征分析，白血病生物学研究，中国食管癌，前列腺癌的激光捕获显微切割和微环境评价，毛细胞白血病患者的免疫毒素耐药性，胃肠道癌放射治疗患者的生物标志物和放射副作用。为了支持这些研究，CMPC拥有许多分子技术的专业知识，用于分析人类样本的DNA，RNA和蛋白质。在广泛的先进平台上发现的最先进的测定包括：DNA测序（桑格和下一代测序）、mRNA表达分析（微阵列、实时PCR、基于珠的）、表观基因组甲基化（微阵列和焦磷酸测序）、阵列比较基因组杂交（微阵列）和组织微阵列。重要的是，CMPC为所有这些检测提供全面的生物信息学支持。

The Clinical Molecular Profiling Core (CMPC) is a collaborative core that seeks to go beyond the common service paradigm of other cores. The expertise of the personnel allows us to be involved from the start of a project, such as the protocol development, though performance of the assay and biostatistical analysis. 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) and the Clinical Center. Over five dozen clinical collaborations have involved many of the branches in CCR such as Medical Oncology, Dermatology, Urologic Oncology, Laboratory of Pathology, Pediatric Oncology, Metabolism, and Radiation Oncology. The status of these collaborations range from preliminary discussions through protocol development, accrual and analysis, and completion. For those that are completed; we look forward to being involved in follow up studies. Many of the studies are clinical trials testing drugs in phase I or II or new combination therapies. These include studies such as Sorafenib and Bevacizumab in Treating Patients With Refractory, Metastatic, or Unresectable Solid Tumors, Pan-HER Inhibitor PF-00299804 in Non-Small Cell Lung Cancer, A Group Wide Biology and Banking Study for Phase II Studies of R1507, "Phase II Study of Belinostat in Patients With Recurrent or Metastatic, Unresectable Thymoma or Thymic Carcinoma Previously Treated With Prior Platinum-Containing Chemotherapy", Phase I/II trial of Vandetanib (ZD6474, Zactima) in Children and Adolescents with Hereditary Medullary Thyroid Carcinoma, Identifying Genomic Aberrations in Pediatric Pontine Glioma, A Phase I Study of the AKT inhibitor Triciribine Phosphate Monohydrate and Erlotinib (Tarceva) in Subjects with Advanced Lung Cancer or other Solid Tumors Who are Resistant to or Naive to Epidermal Growth Factor Receptor (EGFR) Inhibitors, and A Targeted Phase I Trial of ZD6474 (Vandetanib; AZCTIMA) plus the Proteasome Inhibitor, Bortezomib (Velcade ), in Adults with Solid Tumors with a Focus on Hereditary or Sporadic, Locally Advanced or Metastatic Medullary Thyroid Cancer (MTC). However, other investigations are more focused on understanding the underlying pathology of specific diseases and are not directly testing a therapy. These studies include Gene Expression Profiling and Phototoxicity in Adults and Children Exposed to Ultraviolet Radiation, Clinical Evaluations and Laboratory Studies in Patients With Chronic Graft-Versus-Host Disease Who Have Undergone a Stem Cell Transplant, Clinical Manifestations and Molecular Bases of Heritable Urologic Malignant Disorders, Collection of Serum and Tissue Samples From Patients With Biopsy-Proved or Suspected Malignant Disease, Large Scale Methylation Analysis of Follicular Lymphoma, Molecular Profiling of Small Cell Lung Cancer, Molecular Profiling of Thymoma Subsets, Leukemia Biology Study, Esophageal Carcinoma in China, Laser Capture Microdissection and Evaluation of the Microenvironment in Prostate Cancer, Immunotoxin Resistance In Patients With Hairy Cell Leukemia, and Biomarkers and Radiation Side Effects in Patients Undergoing Radiation Therapy for Gastrointestinal Cancer. To support these studies, the CMPC has expertise in many molecular technologies for the analysis of DNA, RNA and protein from human specimens. State of the art assays found on a wide range of advanced platforms 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 tissue microarrays. Importantly, the CMPC provides full bioinformatics support for all these assays.