The purpose of this Funding Opportunity Announcement is to solicit applications for Clinical Validation Centers (CVCs); one of the three scientific units of the Early Detection Research Network (EDRN).
Donor Name: National Institutes of Health
State: All States
County: All Counties
Territory: Commonwealth of Puerto Rico, U.S. Virgin Islands, Guam, American Samoa, Commonwealth of the Northern Mariana Islands
Type of Grant: Grant
Deadline: 09/19/2022
Size of the Grant: $6.6M
Grant Duration: 5 years
Details:
EDRN is an integrated infrastructure to develop and validate biomarkers and imaging methods for the detection of early-stage cancers and risk assessment. Clinical Validation Centers (CVCs) will conduct research to validate biomarkers and/or imaging methods for risk assessment and detection of early-stage cancers. CVCs will also serve as resource centers for collaborative research within the EDRN by partnering with Biomarker Characterization Centers (BCCs) to provide high-quality specimens for Phase 1 and 2 biomarker refinement studies, as well as collaborating with other CVCs, BCCs, and the DMCC for conducting Network collaborative biomarker validation studies. The CVCs must also have the expertise and ability to conduct Phase 4 clinical utility trials of validated early detection biomarkers and/or imaging methods. The other two scientific units of the EDRN are BCCs and a Data Management and Coordinating Center (DMCC).
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 pre-neoplastic 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 multiple 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 precompetitive data and/or image sharing on 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. The EDRN has established a five-phase biomarker development framework as a standard and a roadmap for successfully translating research on biomarker applications from the laboratory to the bedside. The five phases for biomarker discovery and validation are:
- Phase 1: The pre-clinical 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.
Funding Information
- NCI intends to commit $4.2M in FY2023 and $6.6M per year in FY2024-FY2027 to fund up to 6 CVC awards.
- An applicant may request a project period of up to 5 years.
Eligibility Criteria
- Higher Education Institutions
- Public/State Controlled Institutions of Higher Education
- Private Institutions of Higher Education
- The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
- Nonprofits Other Than Institutions of Higher Education
- Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
- Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)
- For-Profit Organizations
- Small Businesses
- For-Profit Organizations (Other than Small Businesses)
- Local Governments
- State Governments
- County Governments
- City or Township Governments
- Special District Governments
- Indian/Native American Tribal Governments (Federally Recognized)
- Indian/Native American Tribal Governments (Other than Federally Recognized)
- Federal Governments
- Eligible Agencies of the Federal Government
- U.S. Territory or Possession
- Other
- Independent School Districts
- Public Housing Authorities/Indian Housing Authorities
- Native American Tribal Organizations (other than Federally recognized tribal governments)
- Faith-based or Community-based Organizations
- Regional Organizations.
For more information, visit Grants.gov.
