ZID BC 011792 (ZID) | |||
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Title | Development of FISH Molecular Diagnostics to support Clinical Trials at NCI | ||
Institution | NCI, Bethesda, MD | ||
Principal Investigator | Pack, Svetlana | NCI Program Director | N/A |
Cancer Activity | N/A | Division | CCR |
Funded Amount | $244,173 | Project Dates | null - null |
Fiscal Year | 2018 | Project Type | Intramural |
Research Topics w/ Percent Relevance | Cancer Types w/ Percent Relevance | ||
Cancer (100.0%) Digestive Diseases (10.0%) Genetic Testing (20.0%) |
Bladder (5.0%) Brain (20.0%) Breast (15.0%) Colon/Rectum (5.0%) Hodgkins disease (5.0%) Kidney Disease (5.0%) Lung (20.0%) Nervous System (20.0%) Non Hodgkins Lymphoma (20.0%) Ovarian Cancer (5.0%) Sarcoma (5.0%) Urinary System (10.0%) Kidney Cancer (5.0%) |
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Research Type | |||
Cancer Initiation: Alterations in Chromosomes Cancer Progression & Metastasis |
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Abstract | |||
Since its inception in 2010 the Chromosome Pathology Section (CPS) of the Laboratory of Pathology generated a valuable resource not previously available at the NIH. The section provides fast and cost-efficient alternative for investigators who were previously required to order expensive Fluorescence In Situ Hybridization (FISH) testing needed for clinical protocol eligibility from reference laboratories. 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 (CPS) receives orders for FISH tests on clinical tumor samples daily, and currently supports 17 clinical trials at the NCI. That includes requests from the entire community of CCR investigators: Neuro-Oncology Branch, Thoracic & GI Malignancies Branch, Vaccine 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. This year CPS has validated new clinical tests for additional frequent chromosomal abnormalities in cancers that have been requested by NCI investigators. Among them are c-MET amplification, RET rearrangement in lung cancer, BCL6 gene rearrangement, PD-L1/2 gene amplification and rearrangement in lymphoid malignancies and solid tumors. CPS actively participates in research collaborations with other investigators within CCR and other NIH Institutes to promote basic and clinical research. One of the recent examples is research and development of the PD-L1/2 clinical FISH test for the detection of gene amplification and rearrangement in lymphoma. The work in collaboration with Dr. Wyndham Wilson group at NIH has demonstrated a successful disease-free anti-PD-1 treatment outcome in patients with mediastinal gray zone lymphoma who were tested positive for PD-L1 gene amplification and rearrangement by FISH in CPS-developed assay (NEJM, 2017). This PD-L1 FISH image highlighted the cover of the last year edition of the WHO 2017 Classification of Lymphoma. The CPS promotes and supports research collaborations with other Investigators within the LP and throughout the Center for Cancer Research (CCR), NCI. The Chromosome Pathology Section is involved in collaboration with 80% of the groups within the LP advancing clinical and basic research efforts of the LP programs This includes establishing many research collaborations with other Investigators within the LP, CCR and other NIH Institutes. The laboratory is in the process of implementing the Illumina methylation microarray testing of the tumors for patients enrolled in the clinical trials at NCI. This will be first laboratory in US to perform clinical methylation analysis under CLIA certification. |