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NATIONAL CANCER INSTITUTE (NCI)

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The goal of the NCI is to eliminate the suffering and death due to cancer. The Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Programs are NCI's engine of innovation for developing and commercializing novel technologies and products to prevent, diagnose, and treat cancer. NCI’s SBIR and STTR Programs offer funding in nanotechnology, anti-cancer agents, biomarkers, proteomics, diagnostics, imaging technologies, pharmacodynamics, and many more areas of interest to the NCI. NCI’s SBIR and STTR programs focus on research, development and delivery and are critical to achieving the institute’s goals. Research opportunities cited below are not all inclusive; those listed are “open-ended” to encourage submission of innovative projects that fit NCI’s mission. For additional information, access the NCI SBIR homepage: http://sbir.cancer.gov/. In addition, please see the contact list at the end of the NCI section to identify the Program Director within the NCI SBIR Development Center who specializes in your technology area. Phase IIB SBIR Competing Renewal Awards NCI offers Phase IIB opportunities that focus on the commercialization of SBIR-developed technologies. Contact the NCI SBIR Development Center at 301-594-7709, NCISBIR@mail.nih.gov for additional information. Center to Reduce Cancer Health Disparities Established in March 2001, CRCHD is the cornerstone of the Institute’s efforts to reduce the unequal burden of cancer in our society. A central goal of the Center is to translate research discoveries into policies and/or services aimed at reducing cancer-related health disparities in racial, ethnic, elderly and medically underserved communities. To learn more about the Center, please visit our website: http://crchd.cancer.gov. The Center is interested in the following SBIR/STTR applications: A. Communication. Training tools to help health professionals deal with issues concerning health literacy and cultural competency. B. Health Care and Epidemiology. Computer software and hardware for hand-held data input and analysis devices; databases and other tools to study patterns of cancer care in underserved communities. C. New Technology. Instrumentation to facilitate early detection and screening, including telemedicine and remote medical imaging, and bioengineering technology (including nanotechnology) applied to cancer detection and diagnosis in underserved communities. D. Geographic Information Systems. Simple, low-cost mapping software to overlay cancer patterns with socioeconomic data, health system infrastructure, healthcare, personal behaviors, ethnicity, risk factors, and consumer profiling among underserved communities. E. Human Genomics. Tools and technology for health care providers using cancer research developments from genomics, pharmaco-genetics and proteonomics for underserved populations. Division of Cancer Biology The Division of Cancer Biology (DCB) plans and directs, coordinates, and evaluates a grant- and contract-supported program of extramural basic research on cancer cell biology and cancer immunology, and cancer etiology, including the effects of biological, chemical and physical agents, in the promotion of cancer; maintains surveillance over developments in its program and assesses the national need for research in cancer biology, immunology and etiology; evaluates mechanisms of biological, chemical and physical carcinogenesis and subsequent tumor growth and progression to metastasis; tests for carcinogenic potential of environmental agents; and serves as the focal point for the Federal Government on the synthesis of epidemiological and experimental data concerning biological agents relating to cancer. For additional information, please visit our home page at http://www.nci.nih.gov/dcb/dcbhom.htm. A. Cancer Cell Biology. The Cancer Cell Biology Branch (CCBB) seeks to understand the biological basis of cancer at the cellular and molecular level. This research utilizes lower eukaryote and animal models, and animal and human tumor cells and tissues to analyze the mechanisms responsible for the growth and progression of cancer. Specific research and technologies supported by CCBB include but are not limited to the following: 1. Development of novel methods and tools to study key aspects of programmed cell death including its regulation and modulation. 2. Development of methods to identify and isolate tissue-specific stem cells. 3. Development of markers associated with specific cellular processes or differentiation. 4. Development of novel techniques, tools, and vectors to transfer functional genes, proteins, antibodies, etc. into intact cells or organisms. 5. New or improved technologies for the efficient microdissection of tumor tissue sections to isolate and preserve human cancer cells appropriate for research. 6. Generation of new inbred genetic animal models that transmit defective or altered cancer-related genes. 7. Development of novel technologies, methodologies, tools, or basic instrumentation to facilitate basic cancer research (research tools). 8. Development of methods and tools to study processes of protein trafficking, post-translational modification, and degradation. 9. Development of novel methods and tools for the analysis of intracellular organelles. 10. Development of novel methods and tools to determine intracellular gradient status. 11. Improved extraction methodologies and tools for tumor specimens for the subsequent analysis of DNA, RNA, and proteins. 12. Development of new or improved methods to isolate intact cellular regulatory complexes for functional studies. 13. Development of novel methods and tools to examine key cellular communication pathways. 14. Improved extraction methodologies and tools for tumor specimens for the subsequent analysis of DNA, RNA, and proteins. 15. Development of new or improved methods to isolate intact cellular regulatory complexes for functional studies. 16. Development of novel methods and tools to examine key cellular communication pathways. B. Cancer Etiology. The Cancer Etiology Branch (CEB) supports research that seeks to determine the role of chemical, physical and biological agents as factors or cofactors in the etiology of human and animal cancer. The biological agents of primary interest are DNA viruses, RNA viruses, AIDS and AIDS-associated viruses, although the research may encompass all forms of life including bacteria and other microbial agents associated with cancer and use animal models of cancer and cancer vaccines. Chemical Carcinogenesis studies are concerned with cancers initiated or promoted by chemical or physical agents. A wide range of approaches are supported, including studies of the genetics of cell transformation, mutagenesis, tumor promotion and DNA damage, as well as studies of basic biochemistry and molecular biology of oncogenic and suspected oncogenic agents, viral oncogenes and associated tumor suppressor genes, pathogenesis and natural history studies, animal models, and preventive vaccine research. Mechanistic studies are encouraged in areas such as metabolism, toxicity and physiological distribution of carcinogens, genetics and regulation of enzymes, biochemical and molecular markers, and organ and cell culture systems and animal models. Also of interest are studies on cancer etiology by environmental chemicals, tobacco consumption and exposure, nutritional hazards, alcohol, asbestos, silica, and man-made fibers. CEB supports studies on endogenous exposure to steroid hormones and the generation of oxygen radicals during normal metabolism, studies on phytoestrogens and xenoestrogens and their impact on the metabolism of endogenous estrogens. In addition, CEB supports the development of analytical technologies to facilitate studies relating to carcinogenesis and mutagenesis. Specific research and technologies supported by CEB include but are not limited to the following: 1. Development of reagents, probes, and methodologies to evaluate the etiologic role of oncogenic viruses and other microbial agents (such as bacteria) in human cancer. 2. Development of novel in vitro culture techniques for oncogenic viruses or other microbial agents associated with or suspected of causing human cancer. 3. Development of sensitive, simplified diagnostic kits or reagents for the detection of oncogenic viruses or other microbial agents. 4. Development and characterization of animal models for studies of the mechanism of cancer induction by viruses or other microbial agents. The animals should faithfully mimic the human diseases associated with the virus or other microbial agent. 5. Development of methods (e.g., new-anti-microbial compounds, new vaccine approaches) to avert the induction of neoplasia in humans and animals by oncogenic viruses or bacteria. 6. Development of other novel technologies, methodologies or instrumentation to determine the role of biological agents, especially viruses, in the etiology of cancer. 7. Development and validation of methods for food treatment, preparation, or processing that will reduce or eliminate carcinogen/mutagen content. 8. Development of rapid analytical techniques for the qualitative and quantitative detection and screening of xenobiotics, chemical contaminants, and carcinogens/mutagens in human foods and biological and physiological specimens. 9. Development of in vitro and in vivo models for basic studies of carcinogenesis in specific organ systems, such as the pancreas, prostate, ovary, central nervous system, kidney, endometrium, stomach, and upper aerodigestive tract. 10. Development of methods for the production of carcinogens, anticarcinogens, metabolites, biomarkers of exposure, oxidative damage markers, and DNA adducts, both labeled and unlabeled, which are neither currently available commercially nor offered in the NCI Chemical Carcinogen Reference Standard Repository. The production of these compounds, in gram quantities, is desired for sale/distribution to the research community. 11. Development of methods for detection, separation, and quantitation of enantiomeric carcinogens, metabolites, adducts, and biomarkers of carcinogen exposure. 12. Development of monoclonal antibodies that are specific for different carcinogen-nucleoside adducts and demonstration of their usefulness in immunoassays. Of particular interest are antibodies to alpha-beta unsaturated carbonyl compounds (such as acrolein and crotonaldehyde) which can form exocyclic nucleoside adducts with DNA, and immunoassays for carcinogen/protein adducts as potential biomarkers of exposure. 13. Development of immunoassays using monoclonal antibodies that are specific for different polymorphs of Phase I and II carcinogen-metabolizing enzymes and repair enzymes. Included, but not limited to, are antibodies to the cytochrome P450 isozymes, glutathione S-transferases, and N-acetyl transferases. 14. Development of rapid, sensitive, and quantitative assays for the identification and measurement of androgens, estrogens, phytoestrogens, and xenoestrogens in complex biological matrices. 15. Development of rapid analytical techniques for the direct measurement of ligand-protein receptor interactions and determination of binding coefficients. 16. Development of analytical instrumentation for the detection and quantitation of extremely low levels of Tritium (3H) or 3H and Carbon-14 (14C) from biological samples. Of particular interest is the development of small-sized, accelerator-based mass spectrometry equipment capable of measuring down to, or below, contemporary background levels of 3H and 14C that would make this sensitive technique more widely available to research groups. The design and development of technologically improved and miniaturized individual components, including ion source, sample preparation (autosampling apparatus), accelerator, and mass spectrometric detectors, are also solicited. 17. Synthesis of selective suicide inhibitors of cytochrome P450 isoforms and selective arachidonic acid pathway inhibitors/ enhancers for basic biochemical studies and anticarcinogenic potential. 18. Development of invertebrate animal models (such as Drosophila, C. elegans, clam, and sea urchin) for the study of environmental chemicals and/or hormonal carcinogenesis. 19. Development of more efficient and reliable methods of preserving valuable animal model gene stocks by innovative in vitro techniques. 20. Development of a defined diet for support and maintenance of aquatic and marine fish models of cancer including but not limited to swordtail, zebrafish, medaka, mummichog, guppy, Fugu, and Damselfish. 21. Development of serum free tissue culture media for aquatic and marine fish models of cancer. C. Cancer Immunology and Hematology. The Cancer Immunology and Hematology Branch (CIHB) supports a broad spectrum of basic research focused on the earliest stages of hematopoiesis and tracing the molecular events that lead to the development of all the functional elements of the immune system and, when errors occur, to the development of leukemias and lymphomas. Most research of interest falls into three major areas. The first is the immune response to tumors to include studies of all of the cells (T, B, NK, antigen-presenting, and other myeloid cells) and secreted molecules (antibodies and cytokines) of the immune system that can recognize and affect tumor growth. Emphasis is placed on the alteration in the mechanisms responsible for the failure of immune response to eradicate most tumors under normal conditions, and the development of strategies to circumvent these mechanisms. A second major area of interest examines the biology of hematopoietic malignancies to describe the molecular biology reasons underlying the cell's failure to respond to normal growth controls and to develop novel approaches to prevention or therapy. The third distinct area supported is the basic biology of bone-marrow transplantation, including studies of host cell engraftment, graft-versus-host disease, and the basis of the graft-versus-leukemia effect. Specific research and technologies supported by CIHB include but are not limited to the following: 1. Development of improved or novel monoclonal antibody technologies including improvements of methodologies for fusion, production of novel cells as fusion partners, selection and assay of antibody producing clones, and production of new and improved monoclonal antibodies. 2. Synthesis, structure and function of antibodies capable of reacting with tumor cells, agents that induce tumors and agents used in the treatment of tumors. 3. Development of in vivo animal models systems that can be used to study the immune response to tumors and the mechanisms of immunotherapy. 4. Synthesis, structure and function of soluble factors that participate in, activate and/or regulate hematopoietic cell growth and the immune response to tumors, including interferons, other lymphokines and cytokines (interleukins), hematopoietic growth factors, helper factors, suppressor factors and cytotoxic factors. 5. Application of biochemical, molecular biological and immunological techniques for identifying tumor antigens that are good targets for the development of vaccine-type strategies of cancer immunotherapy. 6. Development of techniques to enhance the immune response to tumors, including modification of tumor cells and/or antitumor lymphocytes to facilitate cancer vaccine strategies. 7. Development of improved methodology for manipulating bone marrow inoculum to decrease the incidence of graft-versus-host disease without increasing the risk of graft failure or leukemic relapse. 8. Development of improved methodology for increasing the number of peripheral blood stem cells available for harvest for use in transplantation, including improved methods of identifying and removing residual leukemic cells in the autologous transplant setting. 9. Development of methods to identify and define human minor histocompatability antigens. 10. Development of novel culture systems to improve the expansion of lymphocytes and dendritic cells. 11. Development of the combination of cell culture and other research tools to better expand human hematopoietic stem cells. 12. Development of improved techniques for computational simulation/modeling of biological processes involved in immunologic defenses against tumor cells such as signal transduction, cell cycle progression, and intracellular translocation. 13. Development of other novel technologies, methodologies or instrumentation to facilitate basic research in either tumor immunology or cancer hematology. 14. Development of molecular, cellular or biochemical techniques to isolate and/or characterize tumor stem cells from hematologic malignancies. D. DNA and Chromosome Aberrations. The DNA and Chromosome Aberrations Branch (DCAB) seeks to study the genome at the DNA and chromosome level, including discovery of genes at sites of chromosome breaks, deletions, and translocations; DNA repair; structure and mechanisms of chromosome alterations; epigenetic changes; radiation- and chemical-induced changes in DNA replication and other alterations; and analytical technologies. Specific research and technologies supported by DCAB include but are not limited to the following: 1. Development of new, improved technologies for characterization of chromosomal aberrations in cancer. 2. Development of new, improved, or high throughput technologies for whole genome scanning for chromosome aberrations in cancer. 3. New or improved technologies to increase accuracy of karyotypic analyses of tumor specimens. 4. New or improved methods to mutate or replace genes at specific sites in intact cells. 5. Development of new, sensitive methods to assess the methylation status of genes. 6. Development and distribution of genomic resources suitable for genomic manipulation or cytogenetic studies. 7. Technologies for assaying for mammalian genes relevant to repair of damage induced by exposure of mammalian cells to ionizing and non-ionizing radiations, with special emphasis on human cells. 8. Methods/approaches to study the repair of DNA lesions induced by exposure of mammalian cells to ionizing radiations (both high- and low-LET). 9. Development and characterization of human cell lines with specific DNA-repair deficiencies. 10. Development of genetic constructs that utilize radiation-responsive regulatory genes to control the expression of targeted structural genes in mammalian cells. 11. Development of new methods/technologies to assay transcription factor binding sites across whole genomes. 12. Use of RNAi and siRNA in the development of novel methods and tools for the study of gene expression, gene silencing, gene regulation, and genome-wide screening in cells and tissues. 13. Development and integration of nanotechnology and microfluidics in the analysis of DNA and chromosomal aberrations and the identification, mapping, and cloning of cancer susceptibility and resistance genes. 14. Development of human tumor cDNA library banks to study gene expression in cancer. 15. Generation of new or improved animal models or non-mammalian models (e.g. flies, worms) as research tools to study human cancers. E. Mouse Models of Human Cancers Consortium. The Mouse Models of Human Cancer Consortium is a program based in the Office of the Director, DCB. The Consortium has the important goal of providing mouse cancer model-related resources and infrastructure to the research community, in part through various outreach activities. The outreach requirement generates the need for innovative educational or informational materials that convey the content of Consortium meetings and symposia, or document hands-on workshops in which models or techniques that are pertinent to mouse modeling are demonstrated. The instructional materials may be CD-ROMs, videotapes, Web-based interactive programs, or other media. F. Structural Biology and Molecular Applications. The Structural Biology and Molecular Applications Branch (SBMAB) focuses on structural and molecular studies to explore the processes of carcinogenesis and tumorigenesis. Areas of interest include structural biology, genomics, proteomics, molecular and cellular imaging, enzymology, bio-related and combinatorial chemistry, bioinformatics, systems biology and integrative biology as they apply to cancer biology. Interests also include modeling and theoretical approaches to cellular and molecular dimensions of cancer biology. Specific research and technologies supported by SBMAB include but are not limited to: 1. Development of new, improved, or high throughput technologies for whole genome scanning for gene identification. 2. Development of systems that will automate the technology of culturing or assaying single cells. 3. New or improved technologies for efficient microdissection of tumor tissue sections for the development of tissue arrays. 4. Improved extraction techniques for tumor specimens for subsequent DNA, RNA, and protein analyses. 5. Rapid methods to isolate intact complexes of regulatory proteins and to separate and identify the proteins for biophysical studies. 6. New or improved technologies for the preservation of small amounts of DNA/RNA/protein samples 7. Development of new techniques and vectors for transfer of genes, proteins, and antisense molecules into cells. 8. Generation of software and computer models for the prediction of macromolecular structure and function. 9. Development of bioinformatic tools for the study of cancer biology including facilitating genome data, gene “mining,” cluster analysis, and data base management. 10. Development of novel gene technology (e.g., microarray, differential display technology) for measurement of differential gene expression levels and functional genomics studies. 11. Development of novel proteomic tools for the analysis of protein expression in cancer biology. 12. Computer-based methodologies to assist in the understanding of signal transduction and cancer biology. 13. Methodologies and techniques for the imaging of macromolecules in vitro and in vivo. 14. Development of other novel technologies, methodologies or instrumentation to facilitate basic research (research tools) in cancer biology. 15. Develop new approaches and technologies for the structural determination of large biomolecular complexes. 16. Development and integration of nanotechnology approaches and tools in basic cancer biology research. 17. Application and development of novel approaches for in vivo and in vitro modifications of protein expression in cells and tissues, e.g. RNAi, microRNA, other small molecules. 18. Mathematical and theoretical models for the understanding of cancer biology. 19. Development of new software and lab analysis tools that will improve the recording and collection of data and experimental protocols in order to facilitate cancer biology research. 20. Technology and software for elucidating molecular interactions and networks. 21. Develop new, improved or high-throughput technologies for analyzing epigenomic changes. 22. Improved software for the integration of heterogeneous data sources. 23. Development of new, improved or high-throughput technologies for understanding the cancer metabolome. G. Tumor Biology and Metastasis. This branch supports research that seeks to understand the interactions of cancer cells with the tumor and/or host microenvironment in order to delineate the molecular mechanisms and signaling pathways of tumor angiogenesis and lymphangiogenesis, cell migration and invasion, tumor progression, and metastasis. This includes examination of cell-cell and cell-matrix interactions, and the roles played by cell growth factors and cytokines, adhesion molecules, cytoskeleton and the nuclear matrix, and matrix-degrading enzymes, as well as studies on the pathology and biology of solid tumors and tumor bearing animals, and the development of technology to facilitate these studies. Emerging areas of emphasis are the microenvironment created by inflammation and the inflammatory signaling molecules in tumor initiation and progression and the role of somatic stem cells in determining tumor progression and metastatic behavior. Stem cell motility, positional information cues from surrounding tissue and adhesion properties together with issues of epithelial-mesenchymal transitions related to cancer progression are supported. Emphasis is also placed on the role of the extracellular matrix and tissue microenvironment during development and tissue morphogenesis, and on the role of glycoproteins in tumor growth, invasion, and metastasis. The branch also focuses on the function of steroid hormones, their receptors and coregulators during tumor growth and progression. Models utilized in these studies may include animal models, tumor tissues/cells, their components, or their products. The development of organotypic models that closely mimic in vivo models is encouraged. Specific research and technologies supported by TBMB include but are not limited to: 1. New technical strategies to identify and assess the function of components of the extracellular matrix. 2. Development of new in vitro cancer models to study the pathology and biology of solid tumors and tumor bearing animals. 3. New in vivo models of angiogenesis, lymphangiogenesis, cancer progression and metastasis. 4. Development of technologies to identify novel factors that modulate angiogenesis and lymphangiogenesis. 5. Identification of genes and/or enzymes associated with glycosylation in tumor cells. 6. Identification of novel coregulators of nuclear steroid receptor superfamily. 7. Development of improved techniques for computational simulation/modeling of biological processes involved in malignant transformation, persistence, or invasion, such as signal transduction, cell cycle progression, and intracellular translocation. 8. Development of new assays or methods to evaluate tumor cell invasiveness. 9. Development of new assays or methods to study molecules and pathways involved in cell-to-cell signaling or communication. 10. Development of appropriate new animal, cellular or organotypic models to study tumor stroma interactions, 3-D models that closely mimic in-vivo conditions. 11. Study roles of cytokines/growth factors released by host cells during inflammation, invasion, tumor progression and metastasis. Division of Cancer Control and Population Sciences The Division of Cancer Control and Population Sciences conducts basic and applied research in the behavioral, social, and population sciences, including epidemiology, biostatistics, and genetics that, independently or in combination with biomedical approaches, reduces cancer risk, incidence, morbidity, and mortality. Laboratory, clinical and population-based research, and health care are translated into cancer prevention, detection, treatment, and rehabilitation activities that cross the life span and the entire process of carcinogenesis, from primary behavioral prevention in youth, to screening, treatment, and survivorship. For additional information, please visit our home page at http://dccps.nci.nih.gov. A. Epidemiology and Genetics. The Epidemiology and Genetics Research Program supports research in epidemiology, biometry, genetic epidemiology, molecular epidemiology, nutritional epidemiology, infectious epidemiology, environmental epidemiology, computing methodology, and multidisciplinary activities related to human cancers. The topics of interest to the Epidemiology and Genetics Research Program (EGRP) are: • Tools for assessment of exposures and biomarkers: o Development of methods for measuring biomarkers of human exposure or susceptibility, and of nutritional status, and methods for monitoring changes in biomarkers for use in cancer epidemiologic studies. o Development of new or improved devices for quantitative measurement of human exposure to environmental carcinogens for epidemiologic studies. o Development of methods to evaluate potential cancer clusters for epidemiologic studies. • Tools for cancer epidemiology studies: o Development of tools to model cancer risks from environmental and occupational agents. o Development of software for electronic capture of risk factor data for cancer epidemiologic studies. o Build consumer-friendly risk prediction models from epidemiologic data. o Development of software for tracking biological specimens for cancer epidemiologic studies. o Development of software for electronic identification, screening, and recruitment of participants, especially minorities, into epidemiologic studies. o Development of Web-based data collection or applicable bioinformatics tools for cancer epidemiology. o Development of software or methods for rapid case ascertainment of cancers. o Development of geographic information systems with special visualization techniques for the simultaneous assessment of environmental exposures and health outcomes. o Development of tools using publicly available data to identify population-based controls for epidemiologic studies. o Development of software for analysis of DNA methylation biomarkers for early detection of prostate or breast cancers with use of specimens from biorepositories. o MicroRNA Profiling in Epidemiologic studies. o Detection of mitochondrial DNA alterations for Cancer Epidemiologic studies. For more information on this program please go to http://epi.grants.cancer.gov. B. Multimedia Technology and Health Communication in Cancer Control. Over the past few decades, advances in technology have played a key role in enhancing the quality of cancer care through improvements in the prevention, diagnosis, and treatment of cancer. A driving force fostering the utilization of media technology to develop cancer communication products and their dissemination is NCI’s Multimedia Technology and Health Communication SBIR/STTR Program. The Program serves as an ‘engine of innovation’ translating cancer research into commercially viable products for primary care professionals, researchers, patients and their families, and the general public. The objectives of this program are to (1) fund science-based, theory-driven, user-centered grants and contracts to translate cancer research into programs, interventions, systems, networks, or products needed by professionals or the public to reduce cancer risk or improve the quality of life of cancer survivors; (2) promote the use of innovative media technology and/or communication approaches in cancer prevention and control applications used in medical and community settings; (3) improve communication behaviors of primary care professions, patients, and care-givers in cancer-related matters; (4) promote organizational infrastructures changes that promote the use of products developed in the program; (5) promote the development of system models; and (6) expand the methods for evaluating ehealth research and developed products. Investigators interested in applying for grants in this SBIR program should access: http://cancercontrol.cancer.gov/hcirb/sbir/ for a list of topics that address current gaps in ehealth research and that are updated during the fiscal year. This site also provides important program requirements and other SBIR information. Division of Cancer Treatment and Diagnosis The Division of Cancer Treatment and Diagnosis funds research into the development of tools, methodologies and therapeutic agents that will better diagnose, assess, cure and effectively treat cancer. We support a spectrum of research projects from preclinical exploratory research and development through clinical trials. A. Cancer Diagnosis. The Cancer Diagnosis Program (CDP) supports the development of technologies, reagents, instrumentation, and methodologies to improve cancer diagnosis or prognosis or to predict or assess response to therapy. This does not include technologies for imaging of patients. CDP also supports the adaptation or improvement of basic research technologies for use as clinical tools. Technologies supported by CDP may be designed to work with tissues, blood, serum, urine, or other biological fluids. Technologies supported by CDP include but are not limited to the following: 1. Technologies for comprehensive and/or high throughput analysis of molecular alterations at the level of DNA, RNA, or protein. Includes for example, mutation detection systems, gene expression arrays, systems for monitoring epigenetic changes (alternative splicing or methylation), high throughput proteomics (including post-translational modification and protein-protein interactions and methods for protein quantitation). 2. Micro-electro mechanical systems (MEMs) and other nanotechnologies for the analysis of DNA, RNA, or protein (e.g., micro-capillary systems, lab on a chip applications, micro-separation technologies). 3. Mass spectrometry for the analysis of nucleic acids or proteins. 4. Discovery and development of new or improved diagnostic markers or probes targeting changes in DNA, RNA, or proteins, including the generation of molecular diversity libraries by phage display and other combinatorial techniques, and affinity-based screening methods. 5. cDNA library technologies, including improved methods for generating high quality cDNA clones and libraries and methods for generating high quality cDNA from tissues (including archived specimens). 6. Resources for clinical research. a. Instruments, technologies or reagents for improved collection, preparation, and storage of human tissue specimens and biological fluids. b. Improved methods for isolation and storage of DNA, RNA, or proteins. c. Tissue and reagent standards: development of standard reagents such as representational DNA, RNA, and proteins and standard tissue preparations to improve the quality of or facilitate the validation of clinical laboratory assays. d. Methodologies for directed micro-sampling of human tissue specimens, including for example, new or improved methodologies for tissue microarrays. 7. Tissue preservation: fixatives and embedding materials or stabilizers that preserves tissue integrity and cellular architecture and simultaneously allows molecular analysis of DNA, RNA, or proteins. 8. Bioinformatics. a. Methods for acquisition and analysis of data associated with molecular profiling and other comprehensive molecular analysis technologies, including for example, analysis of microarray images and data as well as methods to combine, store and analyze molecular data produced by different techniques (e.g., combined analysis of proteomics and gene expression data). b. Methods for collecting, categorizing or analyzing large data sets containing pathology data or histological images and associated clinical or experimental data, including for example, tumor marker measurements, tissue microarray data, and other relevant biological information. c. Software/algorithms to interpret and analyze clinical and pathology data including methods that relate data from clinical databases to external data sources. Includes for example, neural networks, artificial intelligence, data-mining, data-trend analysis, patient record encryption protocols, and automatic diagnostic coding using standard nomeclatures. d. Informatics tools to support tissue procurement and tissue banking activities. 9. Statistical methods and packages designed for data analysis including correlation of clinical and experimental data. 10. Automated Cytology. a. High resolution image analysis for use with specimens (e.g., blood, tissues, cells) and tissue microarrays. b. Instrumentation including microscopy and flow cytometry. c. CGH, FISH, immunohistochemical staining and other hybridization assays using probes with fluorescent or other novel tags. d. Methods for single cell isolation and sorting. e. Methods for single cell classification and analysis. 11. Instrumentation for the detection and diagnosis of tumors, including endoscopy and magnetic resonance spectroscopy (MRS). 12. Immunoassays using monoclonal, polyclonal, or modified antibodies. Affinity-based binding assays using libraries of aptamers including chemical ligands, small peptides or modified antibodies. For additional information about areas of interest to the CDP Technology Development Branch, visit our home page at: http://cancerdiagnosis.nci.nih.gov. B. Biochemistry and Pharmacology. Preclinical and Exploratory Investigational New Drug (IND) studies designed to improve cancer treatment. General areas of interest: Discovery of new drugs or drug combinations and treatment strategies, selective targeting, development of clinically relevant preclinical models, pharmaceutical development, ADME (absorption, distribution, metabolism and excretion) studies and toxicologic evaluations, understanding mechanisms of drug actions (responses to therapies), and preventing and overcoming drug resistance. Areas of current emphasis: Molecular targeted approaches, including application of safety and efficacy biomarkers to the discovery and development of drugs; application of advanced technologies, such as nanotechnology and imaging technologies, to improved assays for quantitation of safety and efficacy biomarkers; approaches that reduce costs and increase speed of preclinical drug development; and approaches that will lead to “personalized medicine,” including better predictions of drug response and adverse reactions, drug-drug interactions, and drug efficacy monitoring. For additional information, please visit our home page at http://dtp.nci.nih.gov and select “Grants/Contracts.” 1. Drug Discovery. a. Design and synthesize novel compounds for evaluation as potential anticancer agents. Synthesize simpler analogs of complex antitumor structures that retain antitumor activity. b. Develop computer modeling and biophysical techniques such as x-ray crystallography and NMR spectroscopy. c. Design prodrugs of anticancer agents that are selectively activated in cancer cells. d. Discover new anticancer agents that exploit unique properties of tumors, that induce or modulate apoptosis, or that induce or modulate differentiation. e. Design and synthesize anticancer prodrugs, latent drugs, or modifiers of cancer drug metabolism or excretion. f. Develop ways to produce adequate quantities of promising natural products or natural product derivatives through total synthesis. g. Develop scale-up and manufacturing technology for the synthesis of materials with promising anticancer potential. h. Develop chemical libraries for anticancer drug screening programs. The generation of small molecular weight libraries (<700 MW, e.g., non-polymeric organic molecules, transition-state analogs, cyclic peptides, peptidomimetics) is encouraged. i. Develop and apply technologies in genetics, genomics, proteomics, glycomics, lipidomics, metabolomics, and systems biology to the discovery of potential drug targets associated with multiple pathways or networks. Design and optimize agents that block or activate targets/pathways that are likely to control, re-program, retard or kill cancer cells, especially cancer initiating cells (often called cancer stem cells). 2. Drug Evaluation. a. Develop and evaluate anti-metastatic and/or anti-angiogenesis agents or strategies, including combination therapies, in appropriate model systems. b. Develop and evaluate anticancer gene therapy in appropriate model systems. The development of new gene delivery approaches is encouraged. c. Develop novel or improved in vitro and in vivo test systems. There is a special need for new types of in vivo tumor models, such as orthotopic tumor models, models using transgenic or gene knockout animals, and models to evaluate agents that induce differentiation or apoptosis or that target cancer initiating cells (often called cancer stem cells). d. Develop strategies to detect, prevent, or overcome drug resistance. e. Develop novel treatment strategies such as extra corporeal treatment. f. Develop new assays based on molecular targets, especially those that may be amplified or altered in cancer cells. For example, develop assays for agents that interact with oncogenes, suppressor genes, signal transduction pathways, transcription factors, or promoters. Assays based on molecular targets that can be adapted for high volume screening of chemical libraries are especially encouraged as well as in vivo models, which can be used for “proof of concept” (i.e., validating selectivity of the agent for the target and confirming that modulation of the target results in antitumor activity). g. Develop cost-effective and useful techniques to improve in vitro cell culture methodology, such as the development of automated systems, serum-free media, or carbon dioxide-free buffering systems to stabilize cell culture performance. h. Identify and employ novel targets for antitumor drug discovery utilizing non-mammalian genetically defined organisms, such as fruit flies, worms, zebrafish and yeast. i. Develop and apply technologies such as microarrays, proteomics or RNAi to improve the efficiency of drug discovery. j. Develop cell lines that contain bioluminescent reporter genes, such as luciferase, that can be controlled by activating specific promoters. 3. Pharmaceutical Development. a. Develop new methods to improve drug solubility for administration of promising antitumor compounds, such as water miscible nontoxic water solubility enhancing agents. b. Develop bioavailable alternatives to the intravenous delivery of cytotoxic chemotherapy. For example, develop new excipients to enhance oral bioavailability of anticancer agents. c. Develop biocompatible additives and excipients for highly concentrated proteins and peptide formulations to enhance bioavailability and stability suitable for subcutaneous delivery of agents. d. Develop improved methods to reduce thrombophlebitis and other related side effects observed following intravenous injection of some anticancer drugs. e. Develop new and innovative techniques for sterilization of parenteral dosage forms. f. Develop in vitro and in vivo models to predict human oral bioavailability of anticancer drugs. g. Develop practical delivery systems involving nanotechnology (dendrimers, nanoparticles, nanoshells, etc.) or other strategies to deliver anticancer drugs to specific target sites. h. Develop new technology to manufacture liposomal and intravenous emulsions in an environmentally friendly manner and in accordance with OSHA standards. i. Develop additives and/or processes to eliminate cold chain storage of biotherapeutic agents, especially vaccines. 4. Toxicology and Pharmacology. a. Develop biochemical or molecular (genomic, proteomic, or metabolomic) response profiles of specific target organs (e.g., bone marrow, gastrointestinal tract, liver, kidney, heart, lung) to permit rapid identification of toxic effects resulting from anticancer drug administration. b. Develop clinically relevant in vitro and/or in vivo tests for estimation and prediction of gastrointestinal toxicity, neurotoxicity (central and peripheral), cardiotoxicity, hepatotoxicity, nephrotoxicity and pulmonary toxicity. c. Correlate in vivo and in vitro models for organ toxicity as described above in 4b. Validate for various anticancer drugs. d. Develop drug metabolism (Phase I and Phase II) profiles for anticancer agents in human, mouse, rat and dog liver S-9, microsomes and slices. e. Develop systems to identify toxic effects of drugs by characterizing reactions with biomolecules or receptors. f. Develop in vitro tests to detect, qualify and quantify toxic effects of antineoplastic drugs. Develop techniques for determining individual variations in drug responses due to genetic polymorphisms or other factors. Develop pharmacodynamic endpoints and surrogate endpoints using appropriate biomarkers to aid in the selection of doses and schedules and the monitoring of responses and toxicity. g. Develop personal computer programs for pharmacokinetics models capable of predicting drug behavior in humans from preclinical pharmacokinetics data in mice, rats, dogs, and non-human primates. h. Investigate and develop techniques for relating specific enzyme activities (both catabolic and anabolic) to body sizes of different species. i. Investigate techniques that would allow parameters, e.g., Km and Vmax for enzymes, to be scaled from preclinical to clinical models. j. Develop analytical strategies applicable to the quantitation of potent anticancer drugs in biological fluids at the pg/ml level, e.g., Bryostatin. k. Develop non-invasive techniques to determine drug distribution in various animal models. l. Evaluate interspecies transporter distribution and its impact on pharmacokinetic parameters, e.g., the impact of pharmacogenetic variation in biodistribution. m. Determine optimal pharmacokinetic sampling schedules for use in dose titration/pharmacodynamic assessment by integrating information such as pre-clinical pharmacokinetic data, physico-chemical drug properties and mechanism of action. n. Develop an in vitro/in situ system for high throughput drug screens for oral bioavailability. o. Develop and deliver organ specific chemo-protective agents. p. Develop and evaluate rapid, cost-effective methods, including biochemical, functional multiplexed, imaging, nanotechnology-based, and microfluidics-based assays, to quantitate surrogate endpoints for determination of doses, dosing schedules, safety, and efficacy of drugs. q. Identify and develop biomarkers to evaluate drug activities and toxicities. r. Develop assays in support of Exploratory Investigational New Drug Studies using biomarkers or other appropriate endpoints. s. Develop, standardize, and validate cost-effective tools for obtaining comprehensive ADME and toxicology profiles that may better predict the performance of drugs in humans. t. Develop and analytically validate assays or tools for measuring safety, efficacy, and dosing biomarkers. 5. Animal Production and Genetics. a. Investigate alternatives to expensive barrier systems for exclusion of pathogens from rodent colonies, e.g., by use of micro-isolator cages, and evaluate their performance. b. Develop and evaluate specialized shipping containers for pathogen-free animals. 6. Natural Product Discoveries. Note that execution of projects in most of these topic areas will require collaboration and signed agreements with countries where the source organism was originally collected. a. Develop techniques for the study of non-culturable organisms in order to identify antitumor agents. b. Develop techniques for the genetic and biochemical characterization and the manipulation of biosynthetic pathways to create leads. Use combinatorial biosynthesis to generate libraries of un-natural natural products as drug leads. c. Use genetic techniques for the identification of microbial consortia, and for the identification and isolation of genes controlling the biosynthetic pathways producing potential antitumor agents. d. Express biosynthetic pathways from microbes or microbial consortia that are known to produce antitumor agents, but in organisms amenable to standard fermentation techniques. e. Investigate new biological methods, such as tissue culture, aquaculture, hydroponics, etc., for the production of natural products as potential anticancer agents. f. Develop new systems of large-scale production using biotransformation, tissue or cell culture, biotechnology, modification of the chemical ecology of producing organisms, etc., in order to produce the large quantities of anticancer drugs needed for preclinical or clinical development. g. Develop methods for the isolation, purification, identification, cultivation, and extraction of microorganisms from unusual marine or terrestrial habitats for antitumor screening. Examples are gliding bacteria, barophilic, endophytic, thermophilic, and tropical canopy organisms. h. Investigate newer methods of isolation and purification, such as super-critical fluid extraction and chromatography, centrifugal countercurrent chromatography or affinity-based separations, in the isolation and purification of natural products with anticancer activity. i. Develop simple immunoassays that can be used to monitor the levels of natural products of interest in simple extracts of the relevant raw material. These assays should be capable of being developed for use “in the field” and also in developing countries. j. Develop analytical and biological methods for isolation, purification and validation of active constituents identified from alternative medicine and complementary studies; use of these purified constituents alone or in combination with conventional anticancer agents. 7. Data Management Systems. a. Develop data support systems for chemical library programs. b. Develop bioinformatics tools to accelerate the identification, functional understanding and validation of drug targets. c. Develop bioinformatics tools to predict ADME and toxicology characteristics of drug candidates. d. Develop “data mining” strategies such as neural networks. e. Develop algorithms for determining optimal drug combinations and for prediction of optimal effectiveness of individual agents. f. Develop bioinformatics tools to support a systems biology approach to drug discovery and development. g. Develop bioinformatics tools to support genomic/proteomic and other "omics" profiling experiments in support of drug discovery and development. C. Cancer and Nutrition. Research to improve the methodology of nutritional assessment in a cancer population. Innovative approaches to evaluate the contribution of nutritional status to response to cancer treatment. 1. Research to improve the methodology of nutritional assessment in a cancer population. 2. Develop means to evaluate the contribution of nutritional status to response to cancer treatment. D. Clinical Treatment Research. Clinical research studies designed to improve cancer treatment. Emphasis is on clinical trials for the evaluation of new therapeutic agents, development of assay systems to measure patient response to chemotherapy, development of prognostic assays, and development of methods of analysis and management of clinical trials data. Studies designed to improve human subject protections for patient access to clinical cancer trials. 1. Evaluation of New Cancer Therapies. a. Conduct clinical trials for the evaluation of new therapeutic agents or modalities of treatment employing drugs, biologics or surgery. b. Clinical trials using “unconventional therapies,” including, but not limited to, behavioral and psychological approaches, dietary, herbal, pharmacologic and biologic treatments, and immuno-augmentative therapies. c. Development and evaluation of new clinical approaches using gene transfer or gene therapy technologies. d. Development and evaluation of new clinical approaches using tumor associated antigens or vaccines in order to enhance immunogenicity. e. Develop and characterize novel chemical compounds that may be useful anticancer agents, either alone or in combination with other modalities such as radiotherapy. f. Develop techniques to lessen the toxicity of existing anticancer treatments. g. Develop new techniques for the delivery of anticancer agents that will maximize therapeutic effects and minimize toxicity. h. Develop new surgical techniques or tools or improve existing techniques that are/may be utilized in cancer treatment. i. Characterize and produce clinical grade monoclonal antibodies to detect and treat malignancies. 2. Development of Prognostic Assays to Monitor Patient Response to Therapies. a. Develop assay systems to measure the response of human tumors to chemotherapy or biologics. b. Characterize drug resistance mechanisms and design methods to overcome clinical drug resistance. c. Develop assays for prognostic factors to identify patient subsets who may benefit from specific cancer treatment therapies. d. Development of assays to assess effects of agents on specific molecular targets in clinical studies. e. Develop new techniques for relating past preclinical information to past clinical results for prediction of future useful clinical agents from future preclinical data (both in vitro and in vivo). 3. Clinical Trials Informatics. a. Develop new tools and methodologies for the analysis of clinical trials results. b. Develop new informatics tools to facilitate clinical trials data entry from the bedside and coordination of data entry and transmission throughout the institution and to other collaborating institutions or organizations. c. Development of novel web-based approaches to clinical trials informatics for transmission of data to NCI or other organizations. Topics include point of treatment data capture and reporting, electronic protocols, OLAP (On-line Analytical Processing), support for the Common Toxicity Criteria, and drug accountability support. d. Develop new interchange standards, based on technologies such as XML, for sharing data among heterogeneous systems. Specific applications areas include, Adverse Even Reporting, Case Report Forms. e. Develop new tools for support of Common Data Elements. f. Develop new approaches for interface with electronic medical records, with intent to streamline data reporting, registration, and toxicity reporting of Clinical Trial information. E. Cancer Imaging Program. The mission of this program is to promote and support: Cancer-related basic, translational and clinical research in imaging sciences and technology, and integration and application of these imaging discoveries and developments to the understanding of cancer biology and to the clinical management of cancer and cancer risk. Toward this effort, CIP 1) funds research in the development of tools, methodologies and imaging agents/probes that will better diagnose, assess, and effectively treat cancer, and 2) supports a spectrum of research projects from preclinical exploratory research and development through clinical trials. Areas of interest include but are not limited to: 1. Development of medical imaging systems for early cancer detection, screening, response to therapy and interventions including image-guided therapy. 2. Development of preclinical and clinical in vivo imaging systems, methods, imaging probes and contrast agents and related image reconstruction, image processing, image display and image-based information as required to detect, classify, monitor and guide therapeutics to cancer and precancerous conditions. 3. Development of methods to assess the value of imaging procedures for the above goals. 4. Development of systems and methods for improved production and distribution of radioactive materials for cancer imaging and/or treatment. 5. Development of systems, methods and their optimization for studying the adverse reactions/effects of image-guided and other diagnostic and therapeutic interventions. 6. Any other investigator-initiated research idea that is relevant to cancer biomedical imaging. 7. Development of systems, methods and their optimization to advance the role of imaging in assessment of response to therapy through increased application of quantitative anatomic, functional, and molecular imaging endpoints in clinical therapeutic trials and dissemination of these systems and methods with appropriate scientific communities. F. Radiation Research. The Radiation Research Program (RRP) supports basic, developmental and applied research (including clinical) related to cancer treatment utilizing ionizing and non-ionizing radiations. Therapeutic modalities include photon therapy, particle therapy, photodynamic therapy (PDT), hyperthermia, radioimmunotherapy (RIT), systemic targeted radionuclide therapy (STaRT), and boron neutron capture therapy (BNCT). Radiation research encompasses a range of scientific disciplines including basic biology, chemistry, physics and clinical radiation oncology. Topics of interest include, but are not limited to, the following areas: 1. Development of devices for planning, measuring, and delivering radiation therapy or related therapies, including devices for patient positioning and quality assurance for the following: (a) ionizing radiation, particularly 3-dimensional conformal radiotherapy (3DCRT) and intensity-modulated radiotherapy (IMRT); (b) PDT; (c) hyperthermia; (d) RIT; (e) STaRT; and (f) particle therapy. 2. Development of devices for dosimetry for (a) ionizing radiation; (b) PDT, particularly those capable of measuring light doses at depth in tissues; (c) thermometry for hyperthermia, particularly non-invasive thermometry; and (d) RIT. Devices may include chemical, solid state, film, biological or ionization systems to detect or read out exposures. Accuracy, precision and linear response are essential over the range of doses and temperatures employed in the research laboratory and/or in the clinic, depending on their intended use. Devices for thermometry during hyperthermia treatment must give accurate readings with the heating device(s) with which they are to be used. 3. Development and evaluation of computer hardware and software for radiation therapy, such as computation algorithms, computer workstations, image guidance techniques, and informatics methods for treatment planning, delivery and outcomes analysis. 4. Development of novel drugs to increase the effectiveness of radiation therapy or related therapies: (a) chemical modifiers of radiation response, particularly small molecules directed at molecular targets involved in tumor radioresistance; (b) photosensitizers for PDT; (c) sensitizers for use with hyperthermia; and (d) prodrugs that are selectively activated within the tumor. 5. Development of drugs to prevent, reduce or reverse normal tissue response, especially the late effects that develop months or years after therapy. Compounds that are based on a rationale for achieving a therapeutic gain (an improved differential response between tumor and normal tissue) are of greatest interest. Enhancement of response must be achieved at radiation doses and treatment schedules employed clinically. 6. Development of predictive assays and monitors of response to radiotherapy, PDT, hyperthermia, STaRT, or RIT. Tools are needed to identify patients that would benefit from specific therapeutic approaches. G. Biological Response Modifiers (BRM). Research on agents or approaches that alter the relationship between tumor and host by modifying the host's biological response to tumor cells with resultant therapeutic benefits. Both preclinical and clinical investigations are conducted on the utility of a wide variety of natural and synthetic agents and on biological manipulations of immunological and non-immunological host mediated, tumor-growth controlling mechanisms in cancer therapy. Studies are encouraged which utilize in vitro assays and/or animal model systems to investigate mechanisms of BRMs. Examples of innovative research include but are not limited to: 1. Evaluation of molecular genetic approaches to discovery of new therapeutic agents, delivery of BRMs or development of gene therapy. 2. Development of improved techniques to synthesize, screen and develop new oligonucleotides including iRNA sequences for therapeutic purposes, such as signal modulation, anti-oncogene or anti-viral effects. 3. Improvement in cell-culturing techniques, e.g., by developing automated cell culture systems, specialized media, or improved methods to induce activation, proliferation or differentiation. 4. Development of new procedures or reagents for the modulation of the suppressor arm of the immune system in experimental models, directed towards successful immunotherapy. 5. Improvement of tumor-associated antigens or vaccines in an attempt to enhance immunogenicity. 6. Evaluating autoimmunity in the context of anti-tumor response in vivo to vaccines. 7. Development of novel in vitro assays for the primary screening of BRMs. 8. Application of observations describing shared receptors and mediators between the neuroendocrine and immune systems in studying immunobiology and immunotherapy of cancer. 9. Development and optimization of viral oncolytic agents. 10. Development of novel or improved methods for process development and manufacture of biotherapeutics, including but not limited to antibodies, recombinant proteins, peptides, oligonucleotides, and products based on viral or bacterial vectors, per executive order (E.O. 13329) mandating federal agencies assist the private sector in manufacturing innovation efforts. 11. Development of innovative methods for monitoring the manufacturing process for biotherapeutics using in-line or on-line process analyzers to improve the efficiency of process controls and determination of production end-points (see Guidance for Industry, PAT-A Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance, www.FDA.gov). 12. Development of methods to more efficiently assess factors related to the ultimate product quality, safety and efficacy of biologics. Division of Cancer Prevention The Division of Cancer Prevention (DCP) directs an extramural program of cancer prevention research including chemoprevention, nutritional science, genetic, epigenetic, infectious agents, and early detection including biomarker development and validation and biometry for the Institute. DCP also supports research training and career development in cancer prevention and early detection and coordinates community-based clinical research in cancer prevention and dissemination of cancer treatment practice through a consortium of community clinical centers. For additional information, please visit our home page at http://www.cancer.gov/prevention/index.html. A. Prevention. Research studies to identify, evaluate, and implement techniques and approaches for the prevention, risk assessment, and early detection of cancer. Those studies capable of achieving these objectives with minimal risk and cost are preferred. 1. Chemoprevention. Studies in which naturally occurring or synthetic agents are identified, or further evaluated for efficacy or safety. Studies involving in vitro assays with cell transformation systems, in vivo assays involving animal models to evaluate agents against typical carcinogenic agents at specific sites, and studies involving clinical chemistry measurement of agents in sera or other biological fluids are of highest program relevance. Studies aimed at improving future research designs for chemopreventive trials; providing additional biological understanding, identification and evaluation of modulation of quantitative or qualitative biological endpoints, and/or markers for surveillance of compliance will also be considered. Examples of tests might include measurements of biochemical parameters, cytological screening techniques, in vitro studies of suppression of oncogene protein products, enhancement of tumor suppressor genes, in vitro toxicological studies, and synthesis of novel chemopreventive agents based on structure/activity relationships. 2. Diet and Nutrition. The Nutritional Science Research Group supports studies that aim to reduce the incidence of cancer through dietary modification, which may include additions, deletions, or substitutions of foods or dietary factors. Topics of interest include the development of: a) Animal models, including transgenic and knockout, to examine the cancer prevention effects of bioactive food components. b) Invertebrate models for the study of bioactive food component-gene interactions involved with cancer prevention. c) Novel technologies for measuring the effects of diet on differential gene expression, epigenetic events, proteomics, and associated metabolomic changes. d) New models/approaches for examining diet on cancer related processes; i.e., cell division, apoptosis, immunity, angiogenesis. e) Educational interactive software packages that focus on dietary exposures and cancer prevention. f) Effective methods for assessing the content of bioactive food components in foods and dietary supplements. g) Bioengineering tools for the study of bioenergetics and obesity. h) New and/or improved diagnostic markers for assessing the nutritional status of individuals prior to developing a neoplasm. i) Technologies for detecting and identifying carcinogenic and cancer protective compounds in foods. j) Surrogate cells for predicting the response to bioactive food components in target tissue(s). k) Methods for the isolation and preparation or synthesis of candidate nutrients in quantities suitable for preclinical and clinical screening. l) Blends/combinations of bioactive food components for cancer prevention. m) Novel technologies for assessing the effects of dietary components on the extracellular matrix and tissue microenvironment. n) Methodologies to understand stem and progenitor cells with the microenvironment as determined by dietary components. o) Approaches for identifying responders from non-responders of dietary prevention intervention strategies. B. Community Oncology. Introduction, application, and evaluation of effective and practical cancer control intervention programs in community settings. Primary emphasis is on the integration and involvement of community physicians and allied health professionals in cancer control efforts and the promotion of linkages between community practitioners/hospitals and other regional resources for cancer control. Objectives are to: (1) reduce the time between research advances in prevention, detection, and patient management and their application in community settings; and (2) expand extend the cancer care knowledge and applications bases; and (3) evaluate new detection and diagnostic methods for specificity, sensitivity, reliability, validity, safety, feasibility and cost when applied to defined or target populations. This may include screening research as well. C. Rehabilitation and Continuing Care. Development and evaluation of rehabilitation or continuing care strategies which directly enhance functioning of patients with cancer or which contribute to understanding of factors impacting utilization of supportive services by cancer patients. Clinical applications include development and testing of interventions to enhance multidisciplinary approaches to cancer rehabilitation, and research on effective symptom management (e.g., cancer-related pain, fatigue, nausea, mucositis). Areas of general program interest include innovative approaches to measuring and enhancing quality of life of cancer patients; research to investigate and enhance clinical decision-making by both patients and physicians; and studies of the impact of individual preferences for health care outcomes and their impact on cancer prevention practices in persons without cancer and on treatment decisions in patients with cancer. D. Early Detection and Screening. New diagnostic or screening methods for early detection of cancer, especially for asymptomatic patients. Detection methods can include any cancer site, although there is more interest in the common cancers, such as those of the lung and colon. Methods should be cost beneficial and applicable in a clinical setting. 1. Studies which identify and document new databases relevant to early cancer detection and propose using new and experimental analytical techniques. 2. Analyses of long-term, follow-up data from completed studies for potential new interpretations based on the passage of time. 3. Studies which propose to develop and evaluate new detection techniques and measures for sensitivity specificity, reliability, validity and safety. 4. Determinations of the cost/benefit or risk/benefit ratios of cancer screening and detection methods when applied in defined or target populations. 5. Currently, the most commonly used method to detect prostatic cancer is the digital rectal examination. Various devices and models would be necessary for the early detection of prostate cancers by physical examination. They would include, but not limited to the following disease states: (1) absence of disease (normal model); (2) benign prostatic hypertrophy; (3) prostatitis; (4) Stage B1 prostatic cancer (T2a); (5) Stage B2 prostatic cancer (T2b); and (6) Stage C prostatic cancer (T3z, T3b, and T4). 6. Development of products that aid the systematic collection and transport of specimens used for the early detection of cancer, including devices for the collection and transport of urine, serum, fecal material, exfoliated cells, and other potential materials. 7. Develop computer utility programs that can increase the clinical uses of existing programs commonly found in medical offices creating age-sex registries, predicting population risks, determining screening needs of patients, reminder systems, etc. Develop bioinformatics to study gene profiling. 8. Develop personal computer programs that can be used to determine population risks and the effect of interventions. These programs might also be adopted to the concept of Community Oriented Primary Care. 9. Use of ultrasonography with color flow imaging for the early detection of cancer. Research on the use of ultrasonography with color flow imaging (US-CFI) for the early detection of cancer of the ovary, breast and/or prostate. Emphasis should be given to the ability of the US-CFI to differentiate between malignant and benign disease at these sites. Criteria for the discrimination of malignant from benign disease would be developed as well as performance characteristics of this method, particularly for breast and prostate. Studies on symptomatic populations should yield sensitivity, specificity and positive predicative values when breast and prostate are the target sites. Studies on asymptomatic populations should yield sensitivity, specificity and positive predicative values when ovarian cancer is the target site. 10. As more women seek mammographic breast screening, the importance of efficient, high speed, “intelligent” mammographic systems capable of acquiring and storing large volumes of images and enhancing image interpretation will become more important. Technological developments of interest are: a. Develop digital mammographic systems for high volume applications with electronic archiving and image analysis capabilities. b. Develop artificial intelligence based interactive image analysis software to enhance mammographic sensitivity and specificity. E. Cancer Biomarkers. The Cancer Biomarkers Research Group (CBRG) promotes research on the discovery, development, and validation of biomarkers for pre-cancer and early cancer detection and relevant technologies so that risk can be more accurately assessed and cancers can be detected at early stages of development. Early detection has the potential to reduce cancer morbidity and mortality. In cancer research, biomarkers refer to substances that are indicative of the presence of cancer in the body. Biomarkers include genes, RNAs, proteins, and metabolites. As the molecular changes that occur during tumor development can take place over a number of years, biomarkers can be potentially used to detect cancers early. Topics of interest include, but are not limited to, the following areas: 1. Discovery, development and/or validation of biomarkers (genomic, epigenomic, proteomic and metabolomic) for precancerous lesions, early cancer detection, and identification of risk. 2. Development of new biological, genetic, histochemical, immunologic, and molecular assay or analyses applied to early cancer detection, risk assessment, or susceptibility. 3. Development of new tools and technologies, including microfluidics and nanotechnologies, for analyzing biomarkers for early cancer detection and risk assessment. 4. In silico data analysis for the discovery and identification of cancer biomarkers. 5. Ancillary studies to discover biomarkers from ongoing prevention and treatment trials and any large studies. 6. Development of statistical and epidemiological approaches to biomarkers evaluation for early cancer detection and risk. Other Research Topic(s) Within the Mission of the Institute For additional information on research topics, contact: Mr. Michael Weingarten Director, NCI SBIR Development Center National Cancer Institute Bldg. 31/10A19 31 Center Drive MSC 2580 Bethesda, MD 20891 (301) 594-7709 Email: weingartenm@mail.nih.gov Website: http://sbir.cancer.gov Dr. Ali Andalibi Program Director and Team Leader Small Business Innovation Research Development Center (SBIR) National Cancer Institute Bldg. 31/10A19 31 Center Drive MSC 2580 Bethesda, MD 20891 Email:andalibia@mail.nih.gov Area of expertise: Biologics, Small Molecules and Therapeutic Surgical Interventions Dr. Gregory Evans Program Director and Team Leader Small Business Innovation Research Development Center SBIR) National Cancer Institute Bldg. 31/10A19 31 Center Drive MSC 2580 Bethesda, MD 20891 Email: evansgl@mail.nih.gov Area of expertise: Cancer Biology, E-Health and Epidemiology, Dr. Andrew Kurtz Program Director Small Business Innovation Research Development Center (SBIR) National Cancer Institute Bldg. 31/10A19 31 Center Drive MSC 2580 Bethesda, MD 20891 Email: kurtza@mail.nih.gov Area of expertise: Biologics, Small Molecules, and Nanotherapeutics Mr. David Beylin Program Director Small Business Innovation Research Development Center (SBIR) National Cancer Institute Bldg. 31/10A19 31 Center Drive MSC 2580 Bethesda, MD 20891 Email: beylind@mail.nih.gov Area of expertise: Cancer Imaging, Radiation Therapy and Image Guided Interventions Dr. Patricia Weber Program Director Small Business Innovation Research Development Center (SBIR) National Cancer Institute Bldg. 31/10A19 31 Center Drive MSC 2580 Bethesda, MD 20891 Email: weberpa@mail.nih.gov Area of expertise: E-Health, Epidemiology, Software Development related to Cancer Control & Population Sciences, and Biologics Dr. Xing-Jian Lou Program Director Small Business Innovation Research Development Center (SBIR) National Cancer Institute Bldg. 31/10A19 31 Center Drive MSC 2580 Bethesda, MD 20891 Email: loux@mail.nih.gov Area of expertise: In-Vitro Diagnostics and Bioinformatics Ms. Deepa Narayanan Program Director Small Business Innovation Research Development Center (SBIR) National Cancer Institute Bldg. 31/10A19 31 Center Drive MSC 2580 Bethesda, MD 20891 Email: Deepa.Narayanan@mail.nih.gov Area of expertise: Cancer Imaging and Clinical Trials Dr. Todd Haim Program Manager Small Business Innovation Research Development Center (SBIR) National Cancer Institute Bldg. 31/10A19 31 Center Drive MSC 2580 Bethesda, MD 20891 Email: Haimte@mail.nih.gov Area of expertise: Diagnostics and Therapeutics For administrative and grants management questions, contact: Mr. Allen Lo Grants Management Specialist MSC 7150 6120 Executive Blvd Rockville, MD 20892-7150 (301) 496-8796 Fax: 301-496-8601 Email: loa2@mail.nih.gov For NCI-related SBIR Information, visit: http://www3.cancer.gov/admin/gab/index.htm
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