Development of FISH Molecular Diagnostics to support Clinical Trials at NCI

开发 FISH 分子诊断以支持 NCI 的临床试验

• 批准号: 10262810
• 负责人: Svetlana Pack
• 金额: $ 77.87万
• 依托单位: DIVISION OF BASIC SCIENCES - NCI
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10262810
• 关键词: American; Basic Science; Biological Assay; Biomedical Research; CCR; Central Nervous System Neoplasms; Chromosomal Duplication; Chromosomal translocation; Chromosomes; Classification; Clinical; Clinical Protocols; Clinical Research; Clinical Trials; Collaborations; Communities; Cytogenetic Analysis; DNA Methylation; Detection; Development; Diagnostic; Diagnostic Services; Diagnostic tests; Eligibility Determination; Event; Fluorescent in Situ Hybridization; Formalin; Gene Rearrangement; Genomics; Glioma; Goals; Gold; Hematologic Neoplasms; Immunology; Institutes; Knowledge; Laboratories; Lung; Lymphoma; Malignant Neoplasms; Malignant neoplasm of gastrointestinal tract; Malignant neoplasm of thorax; Methylation; Modernization; Molecular; Molecular Cytogenetics; Oncogenes; Operative Surgical Procedures; Paraffin Embedding; Pathology; Patients; Pediatric Oncology; Pharmaceutical Preparations; Protocols documentation; Research Personnel; Resources; Solid Neoplasm; Surgical Pathology; Testing; Therapeutic; Transplantation; United States National Institutes of Health; Urologic Oncology; Vaccines; base; bench to bedside; cancer genomics; cancer therapy; chemotherapy; clinical diagnostics; clinically significant; college; cost; design; genome-wide; genomic profiles; improved; malignant breast neoplasm; methylation testing; molecular diagnostics; molecular pathology; neuro-oncology; novel diagnostics; personalized diagnostics; precision medicine; prognostic; programs; research and development; research clinical testing; standard of care; targeted treatment; tumor

The Chromosome Pathology Section (CPS) of the Laboratory of Pathology is a valuable resource at CCR, NCI to support active NCI clinical protocols. The section provides clinical diagnostic service for CCR investigators with Fluorescence In Situ Hybridization (FISH) CLIA/CAP testing in support of Surgical Pathology diagnostics and testing patients for NCI clinical protocol eligibility. More importantly, the laboratory represents a bench-to-bedside bridge that keeps pace with the latest discoveries in biomedical research, bringing new discoveries to clinical patient testing more rapidly than would be available from reference laboratories (the R&D component of the CPS). The Chromosome Pathology Section currently supports 16 clinical trials at the NCI. That includes requests from the entire community of CCR investigators: Neuro-Oncology Branch, Thoracic & GI Malignancies Branch, Vaccine Branch, Pediatric Oncology Branch, Experimental Transplantation and Immunology Branch, Surgery Branch, Urologic Oncology Branch, Office of the Director. The active test menu includes FISH assays for clinically significant chromosomal translocations and amplification events in solid tumors and hematologic malignancies. CPS actively participates in clinical and research collaborations with other investigators within the CCR and other NIH Institutes to advance basic and clinical research. The CPS promotes collaborations with other Investigators within the LP advancing clinical and basic research efforts of the LP programs. In addition to Molecular Cytogenetic testing, we have recently implemented an exciting new diagnostic clinical testing that uses Illumina platform for array-based genome-wide DNA methylation testing to to classify CNS tumors based on their unique genomic methylation profiles. This CPS group effort within the NCI COMPASS program has been a step forward for the goal to enhance the diagnostics precision in CNS and other tumor classification

病理学实验室的染色体病理学部分（CPS）是CCR，NCI的宝贵资源，以支持积极的NCI临床方案。该科为CCR研究者提供荧光原位杂交（FISH）CLIA/CAP检测的临床诊断服务，以支持外科病理学诊断和检测患者的NCI临床方案资格。更重要的是，该实验室代表了一个从实验室到床边的桥梁，与生物医学研究的最新发现保持同步，比参考实验室（CPS的研发部分）更快地为临床患者测试带来新发现。染色体病理科目前支持NCI的16项临床试验。这包括CCR研究者的整个社区的请求：神经肿瘤分支、胸胃肠道肿瘤分支、疫苗分支、儿科肿瘤分支、实验移植和免疫学分支、外科分支、泌尿肿瘤分支、主任办公室。活动测试菜单包括实体瘤和恶性血液病中具有临床意义的染色体易位和扩增事件的FISH检测。CPS积极参与临床和研究合作，与CCR和其他NIH研究所内的其他研究人员，以推进基础和临床研究。CPS促进与LP内其他研究者的合作，推进LP项目的临床和基础研究工作。除了分子细胞遗传学检测，我们最近还实施了一项令人兴奋的新诊断临床检测，该检测使用Illumina平台进行基于阵列的全基因组DNA甲基化检测，以根据CNS肿瘤独特的基因组甲基化谱对其进行分类。CPS小组在NCI COMPASS项目中的努力是朝着提高CNS和其他肿瘤分类诊断精度的目标迈出的一步