The Early Detection Research Network: Biomarker Characterization Centers (U2C Clinical Trial Not Allowed)

RFA-CA-22-040

The EDRN provides an infrastructure to expedite the clinical application of molecular and imaging data through its knowledge environment, which was developed in collaboration with NASA's Jet Propulsion Laboratory (JPL). The architecture of the knowledge environment is based on supporting and linking diverse molecular data (genomics, proteomics, etc.) to clinical phenotypes and imaging. The EDRN Informatics Center at JPL (JPL IC) leverages cloud-based capabilities to support the increasing data and computational demands of the program. The infrastructure also supports capabilities to run repeat analyses of complex genomics and proteomics data, image analysis including radiomics, and other complex data types. Over the years, EDRN has built several data repositories on biomarkers, imaging, and analytical tools. These resources will be employed to help build specific, interoperable data platforms that will allow investigators to mine and analyze data using artificial intelligence (AI) and other machine learning languages (MLL). Data science is poised to play a major role in new or improved risk stratification, early detection, and precision prevention strategies, particularly in patients with ambiguous symptoms or at high risk for the disease. In recent years, EDRN has amassed large amounts of imaging data and combined it with clinical information to diagnose patients, recognize tumor types, and/or make any follow-up care and treatment decisions. These imaging and data analytics will provide unprecedented opportunities for in silico biomarker discovery, accurately identify early-stage aggressive neoplasms from indolent or benign lesions for many cancers and make more accurate predictions about their aggressiveness. 

EDRN's specific interests include but are not limited to the following:

• Discover, develop, evaluate, and validate promising 'omic' biomarkers (e.g., genomic, proteomic, epigenomic, metabolomic) for effective cancer risk assessment, early detection, and diagnosis and prognosis of early-stage cancers and preneoplastic lesions.
• Develop and validate biomarkers to improve the detection of cancer progression for patients on active surveillance.
• Develop and implement diagnostic assays/tests for accelerating biomarker discovery and translation into the clinic. This would include measures of diagnostic or predictive accuracy, sensitivity, and specificity.
• Facilitate the development of high-throughput, sensitive assay methods to identify, verify and validate biomarkers that are useful in the assessment of risk, detection, diagnosis, and prognosis of early-stage cancers or their lethal precursors.
• Integrate molecular biomarkers with imaging approaches to improve the performance of tests, reduce false-positive rates, and improve the detection of clinically significant cancers.
• Implement, expand and/or modify new or existing imaging modalities, protocols, and associated informatics to improve the performance of tests.
• Develop and implement AI and MLL algorithms to facilitate the discovery and translation of multiplex biomarkers. 
• Support collaboration among academic and industrial leaders, whose areas of interest are in molecular biology/molecular genetics, imaging, data science, clinical oncology, public health, and/or other related areas, leading to the development of early cancer diagnostics.
• Conduct clinical/epidemiological studies (e.g., cross-sectional, prospective, retrospective) in order to evaluate the predictive value of biomarkers.
• Improve the informatics infrastructure to facilitate pre-competitive data and/or image sharing for biomarker discovery, development, and validation.
• Serve as a core resource so that NCI and the cancer community at large can leverage the well-developed EDRN infrastructure and expertise in order to facilitate translational cancer research, clinical utility trials, and cancer prevention and therapeutic trials.

These goals are achieved through a systematic, evidence-based discovery, development, and validation of biomarkers, based upon standard operating procedures (SOPs) and common data elements (CDEs) developed by the EDRN investigators, as well as Network scientific, operational, and organizational policies and procedures, as described in the EDRN Manual of Operations (MOP) (https://edrn.nci.nih.gov/about/bookshelf). The EDRN has established a five-phase biomarker development framework as a standard and a roadmap for successfully translating research on biomarkers from the laboratory to the bedside. The five phases for biomarker discovery and validation are:

• Phase 1: The preclinical exploratory phase;
• Phase 2: The clinical assay validation phase (case-control);
• Phase 3: The retrospective longitudinal validation phase;
• Phase 4: The prospective screening phase; and
• Phase 5: The cancer control phase.

A budget of up to $500,000 per year (direct cost) may be requested for Year 1 (FY 2023), and a budget of up to $725,000 per year (direct cost) may be requested for Years 2-5 (FY 2024-2027). 

30 days prior to the application due date

September 08, 2022

Sudhir Srivastava, Ph.D., M.P.H., National Cancer Institute (NCI), Telephone: 240-276-7028, Email: srivasts@mail.nih.gov