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Cancer Biomarkers Research Group

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Extraordinary Opportunities for Early Cancer Detection and Risk Assessment Research

Early Detection Research Network

This initiative supports the creation of a national Network for early cancer detection with resources for translational research that will include laboratory science, clinical science, public health, biostatistics, informatics, and computer science. The goals of the Network are to discover and coordinate the evaluation of biomarkers and reagents for the earlier detection of cancer and for the assessment of risk. Specifically, the objectives of the Network include:

  • the development and testing of promising biomarkers or technologies in institutions having the scientific and clinical expertise to obtain preliminary information that will guide further testing;
  • the timely and early evaluation of promising, analytically proven biomarkers or technologies, including measures of predictive accuracy, sensitivity, and specificity;
  • the evaluation of biomarkers as intermediate endpoints for early detection and for prevention;
  • the timely development of biomarkers and expression patterns, sometimes of multiple markers simultaneously, which will serve as background information for subsequent large definitive validation studies in the field of cancer detection and screening;
  • collaboration among academic and industrial leaders in molecular biology, molecular genetics, clinical oncology, computer science, public health, etc., for the development of high-throughput, sensitive assay methods for biomarkers from an early detection and risk assessment viewpoint;
  • conducting early phases of clinical/epidemiological studies, e.g., cross-sectional and retrospective, to evaluate predictive value of biomarkers; and
  • encourage collaboration and rapid dissemination of information among awardees to ensure progress and avoid fragmentation of effort.

A multi-step process of biomarker development and validation determines the eligibility of a marker for clinical use. Tremendous efforts are needed to ensure that a marker is reliable and practical for medical application. To identify, develop, and validate molecular markers for earlier cancer detection and risk assessment, the EDRN is organized into four working and two oversight components.

  • The Biomarker Developmental Laboratories Exit Disclaimer focuses on the development and molecular characterization of new or the refinement of existing biomarkers for preneoplastic lesions detection and/or identification of high-risk populations.
  • The Biomarker Reference Laboratories Exit Disclaimer facilitates research on validation studies on the biologic and prognostic markers of the preinvasive and invasive neoplasia by serving as an EDRN resource for clinical and laboratory validation of biomarkers, which includes technological development, quality control, refinement, and high-throughput.
  • The Clinical and Epidemiology Centers Exit Disclaimer conducts clinical and epidemiological research on the clinical application of biomarkers and provide resources, such as tissue specimens, for EDRN validation studies.
  • The Data Management and Coordinating Center Exit Disclaimer provides statistical, computational, and logistical support to the entire EDRN, including study design consultation, data analysis and coordination.
  • The Steering Committee Exit Disclaimer provides major scientific oversight with responsibility for developing and implementing EDRN protocols, publications, design and operation.
  • The Advisory Committee reviews the progress of the EDRN, recommend new research initiatives, and ensure that the Network is responsive to promising opportunities in early detection research and risk assessment.

Investigators in the EDRN perform both retrospective and prospective studies to identify and evaluate early detection and risk assessment biomarkers. The retrospective studies on specimens collected saves funds and accelerates the validation of biomarkers while leading to a better understanding of the relationship between a molecular event and cancer. Prospective studies assessing biomarkers, however, is required before the screening value of genetic or molecular changes can be firmly established. Such validation studies should be conducted through ongoing prospective, preferably randomized trials. In absence of such trials, clinical studies with large numbers of serially biopsied specimens, should be supported to measure the validity of the biomarkers.

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