Key Dates

Related Announcements

PA-20-272 - Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)

RFA-CA-22-055 - Cancer Prevention-Interception Targeted Agent Discovery Program (CAP-IT) Centers (U54 Clinical Trial Not Allowed) Published
RFA-CA-21-038 - Cancer Prevention-Interception Targeted Agent Discovery Program (CAP-IT) Centers (U54 Clinical Trial Not Allowed)

Issued by

National Cancer Institute (NCI)

Purpose

This Notice of Special Interest informs current National Cancer Institute (NCI) U24 awardees that the National Cancer Institute (NCI) is providing the opportunity for supplemental funding to establish a centralized database and manage ongoing and future activities of the Cancer Prevention-Interception Targeted Agent Discovery Program (CAP-IT) formed by RFA-CA-21-038 and RFA-CA-22-055. Through this administrative supplement, the NCI seeks to establish the CAP-IT Data and Resource Coordination Center (CAP-IT DRCC) to enhance cross-network collaborations and rapid completion of projects, data access, and data sharing.

These supplements will achieve the following:

• Support the CAP-IT network data sharing by establishing and managing a centralized CAP-IT research database for the entire network in coordination with each CAP-IT U54 Center’s Informatics group in accordance with the policies established by the CAP-IT steering committee (SC).
• Facilitate in-network sharing of research tools and resources by establishing a centralized information hub for shareable tools and resources in accordance with the policies established by the CAP-IT SC.
• Support the CAP-IT program operation by providing program management support, including logistical and administrative assistance on in-network communications and cross-network collaborative activities, and coordinating and facilitating network-wide meetings.

Background

While much progress has been made in the development of new or improved methods of determining a cancer risk and detecting and monitoring emerging precancer, current approaches for cancer risk reduction are still centered on surgical procedures. With the increasing knowledge of early drivers of the oncogenic process, reduction in cancer mortality can be significantly improved if oncogenic pathway-targeted interventions are successfully deployed to further mitigate cancer risk and better manage precancer especially in higher-risk populations. Because higher-risk populations represent a diverse group of individuals with different genetic susceptibilities, varying histories of exposure to carcinogens, different lifestyles, age, gender, and the presence of other comorbidities, it is nearly impossible to find and deliver universally efficacious cancer preventive interventions in this heterogenous population. A more rational approach to cancer prevention and interception in higher-risk cohorts is to employ preventive measures specifically tailored for individual risk factors, an approach referred to as precision cancer prevention-interception. Success of precision cancer prevention-interception depends on two complementary steps. First, higher-risk individuals need to be identified, e.g., through screening and early detection of precursor/precancers, some of which may progress to cancer, and testing for genetic susceptibility. Second, innovative, safe, and efficacious measures designed to reduce cancer risk or molecularly/immunologically intercept, arrest, and possibly eliminate precancer in these higher-risk individuals are needed to complement or replace surgical resection or ablation. However, because very few target-specific agents are available for these higher-risk individuals, current cancer interception strategies predominantly rely on surgical interventions. It is this gap in discovering and bringing risk-tailored targeted agents to the higher-risk populations for cancer prevention and interception that CAP-IT will address.

There are existing NCI programs with accessible genomic and molecular profiles and biomarker databases that can reveal potentially exploitable targets for cancer prevention and interception. These include the Pre-Cancer Atlas (PCA) in the Human Tumor Atlas Network (HTAN), NCI Consortium of Molecular and Cellular Characterization of Screen-detected Lesions (MCL), the Cancer Genome Atlas (TCGA; through NCI Genomic Data Commons, GDC), NCI Clinical Proteomic Tumor Analysis Consortium (CPTAC), and Cancer Target Discovery and Development (CTD2). Furthermore, Early Detection Research Network (EDRN) and other biomarker discovery and translational research initiatives continually uncover oncogenic driver pathways and networks, some of which can be targeted to prevent or intercept the oncogenic process. CAP-IT is intended to take advantage of these existing program databases and establishes a new discovery research paradigm in cancer prevention that leverages the potential oncotarget leads identified from precancer biology research and related databases and exploits their oncogenic characteristics and vulnerabilities to discover innovative cancer prevention-interception agents especially focusing on higher-risk populations. The ultimate goals of CAP-IT are to advance newly discovered efficacious cancer preventive or interceptive agents to the existing NCI, Division of Cancer Prevention preclinical and clinical development pipelines, PREVENT Program for further development towards IND and Cancer Prevention Clinical Trials Network (CP-CTNet) for early phase clinical trials, and thereby to establish a scientific roadmap and a more streamlined foundational infrastructure for fast-tracking agent discovery and development for cancer prevention and interception from bench to bedside.

CAP-IT Goals and Functions of the CAP-IT DRCC

The CAP-IT program's overarching goal is to discover molecularly or immunologically targeted agents designed to prevent or intercept the oncogenic process for precision cancer prevention and interception. To achieve the goal, CAP-IT research objectives are as follows:

• To identify targets that can be potentially exploited for cancer preventive or interceptive interventions specifically in higher-risk populations, by collaborating with the NCI and other programs with a research focus on molecular profiling of precancer, early cancer, and/or oncogenic signaling pathways. High-value tumor-driving molecular targets/pathways, immune targets, and tumor-specific/tumor-associated antigens, collectively referred to as "oncotargets" in this FOA, will be prioritized for the discovery of targeted interventions;
• To functionally validate the critical roles of the high-value oncotargets in tumor initiation and/or progression to invasive cancer and select oncotargets suitable for targeted intervention strategies; and
• To discover innovative targeted agents through in vitro and in vivo efficacy evaluation and advance promising efficacious agents to the NCI's existing R&D pipeline for further development.

The CAP-IT DRCC will function as the Program’s centralized data management and network activity coordination center with the following responsibilities:

• CAP-IT research database: Establishing and managing a centralized CAP-IT research database for the entire network in coordination with each CAP-IT Center’s Informatics group in accordance with the policies established by the CAP-IT SC.
• Network research tools and resources information: Facilitating in-network sharing of research tools and resources (e.g., novel assay technologies, protocols, preclinical biospecimens, and agents) by establishing a centralized information hub for shareable tools and resources in accordance with the policies established by the CAP-IT SC.
• Program operational support: Providing program management support, including logistical and administrative assistance on in-network communications and cross-network collaborative activities, and coordinating and facilitating network-wide meetings (e.g., CAP-IT SC meetings, Annual CAP-IT Investigators’ meetings, workshops, and seminars).

The CAP-IT DRCC PI will be a member of the CAP-IT Steering Committee. Each CAP-IT Center (U54) is expected to develop new additional projects under the direction of the CAP-IT Center PDs/PIs and other designated leadership members. The CAP-IT DRCC may be tasked to aid new project development processes by facilitating in-network communications and sharing of data, resources and/or tools.

CAP-IT Trans-Network Activities applicable to the CAP-IT DRCC will include but are not limited to:

• Interacting with the CAP-IT Centers’ informatics groups to establish a centralized CAP-IT research database for in-network data archiving and sharing in accordance with the policies established by the CAP-IT SC;
• Facilitating in-network sharing of new research tools and resources (e.g., novel assay technologies, protocols, preclinical biospecimens and agents) developed through the conduct of CAP-IT research by establishing a centralized information hub for shareable tools and resources in accordance with the policies established by the CAP-IT SC;
• Coordinating, facilitating, and participating in network-wide meetings, such as an Annual CAP-IT Investigators’ Meeting, workshops, seminars and CAP-IT SC meetings.

Eligibility

• Administrative supplement applications are limited to currently funded projects supported by NCI.
• PDs/PIs must hold an active eligible U24 grant supported through NCI - no other grant mechanisms are eligible for this program.
• For supplements to parent awards that include multiple PDs/PIs, the supplement may be requested by any or all of the PDs/PIs (in accordance with the existing leadership plan) and submitted by the awardee institution of the parent award.
• NCI awardees that are currently funded as Coordinating Centers for ARTNet program will be prioritized for this award.
• The CAP-IT DRCC must have appropriate expertise, background, skills, managerial capacity, and established infrastructure required to carry out the Center responsibilities and must have the following key attributes:

1. Leadership and Management Vision: The CAP-IT DRCC must be able to provide centralized data management for the CAP-IT in coordination with each CAP-IT Center Informatics group. Accordingly, the CAP-IT DRCC must demonstrate strong leadership, innovative thinking, expertise, and managerial capacity to bring individual Center Informatics groups together and build the database team to implement data management and sharing policies established by the CAP-IT SC.
2. Data Coordination and Centralized Data Management: The CAP-IT DRCC must be able to work closely and coordinate with each CAP-IT Center Informatics group, formulate and deploy management techniques for quality data collection and integration, develop and maintain a centralized database, and devise and implement secure procedures for data management and in-network sharing. The CAP-IT DRCC will leverage, where feasible, technology from related NCI-sponsored informatics initiatives, for example the NCI Informatics Technology for Cancer Research (ITCR) program, which supports the development of algorithms, tools, and resources across the continuum of cancer research.
3. Resource Coordination: In addition to in-network sharing of the Program research data, the CAP-IT DRCC is expected to facilitate in-network sharing of shareable research tools and resources (e.g., novel assay technologies, protocols, preclinical biospecimens and agents) generated through the conduct of CAP-IT research in accordance with the policies established by the CAP-IT SC. The CAP-IT DRCC should plan to work with each CAP-IT Center Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) or their designated representative(s) on creating a centralized information hub concerning network-shareable digitally identifiable research tools and resources in accordance with the policies established by the CAP-IT SC. The CAP-IT DRCC should also establish access protocols for these data to facilitate efficient sharing of shareable resources and technologies among CAP-IT investigators.
4. Administrative and Logistical Support: The CAP-IT DRCC is expected to provide program management support, including administrative and logistical assistance on in-network communications and cross-network collaborative activities, and coordinate and facilitate network-wide meetings. The CAP-IT DRCC must establish and maintain unified and coordinated procedures for network-wide communications with the CAP-IT Centers and NCI and be able to function as an information and implementation hub for CAP-IT trans-network activities.

Application and Submission Information

Applications for this initiative must be submitted using the following opportunity or its subsequent reissued equivalent.

• PA-20-272 - Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)

All instructions in the SF424 (R&R) Application Guide and PA-18-591 must be followed, with the following additions:

• Application Due Date: Submissions must be received by February 28, 2023 at 5:00 PM local time of applicant organization for FY 2023 funding.
• For funding consideration, applicants must include “NOT-CA-23-012” (without quotation marks) in the Agency Routing Identifier field (box 4B) of the SF424 R&R form. Applications without this information in box 4B will not be considered for this initiative.
• Applicants should begin the supplement application abstract by stating “This application is being submitted in response to the Notice of Special Interest (NOSI) identified as NOT-CA-23-012.”
• Budget and Period of Support:
  • One CAP-IT DRCC will be awarded with a maximum total cost of $800,000 per year (maximum direct cost is $480,000 per year) in fiscal year 2023. It is expected that $800,000 per year will be available in fiscal years 2024 through 2026, but support for future years of funding will depend on the availability of funds.
  • At least one full year on the parent grant must remain at the time of funding. The application budget is limited to four years. Funds from this supplement must be expended within 48 months of the supplement award issue date.
  • Requests for no-cost extensions on the parent grant to accommodate a supplement will not be permitted.
  • Funds from this supplement may be used to cover costs associated with completing the CAP-IT SC approved program activities, including, but not limited to data collection, data preparation, data harmonization, analyses, and publication costs, and travel to investigator meetings that facilitate collaborations on the CAP-IT program project during the supplement period.

• The Research Strategy must not exceed the page limitations applicable to the parent award. The Research Strategy must consist of the following sub-sections A - E.

Sub-section A. The Overview of the Proposed CAP-IT DRCC Capabilities

This section must address the following key elements:

1. The overall vision of the proposed CAP-IT DRCC to achieve the Center’s key responsibilities and support CAP-IT research objectives. Describe any unique approaches that reflect innovative and strategic thinking.
2. The proposed organization and staffing of the CAP-IT DRCC. Without repeating information in individual biosketches and Facilities and Other Resources, highlight major strengths and critical experience of the proposed leadership and key personnel team, particularly in experiences in database construction and management, program communications and coordination in support of multi-institutional projects and/or trans-disciplinary research program, and logistical support to promote scientific collaborations.
3. Institutional infrastructures and resources available to the proposed CAP-IT DRCC. Describe the institutional resources that can contribute to the successful operation and activities of the CAP-IT DRCC, including but not limited to collecting and integrating individual CAP-IT Center’s research data; managing the Program centralized database; facilitating in-network data and resource sharing and trans-Center collaborations and interactions; facilitating the planning of the Annual Investigators’ meeting and addressing logistics; and providing program management support.

Sub-section B. Leadership and Administration Unit

This section must address the following key aspects:

1. The structure and organization of the Leadership and Administration Unit of the proposed CAP-IT DRCC.
2. Mechanism(s) of general oversight on the proposed CAP-IT DRCC operation and its contributions to the CAP-IT and plans to ensure the CAP-IT DRCC will meet the Center responsibilities.
3. Plans and capacity for providing administrative and logistical support for trans-network activities for the CAP-IT (e.g., the Annual CAP-IT Investigators’ Meetings and CAP-IT SC Meetings) and facilitating in-network communications and cross-network collaborative activities.

Sub-section C. CAP-IT Centralized Database Management

This section must address the following key aspects:

1. Plans for collaborating and coordinating with each CAP-IT Center Informatics group to identify and catalogue the Center’s CAP-IT research data in preparation for data transfer.
2. Plans and capacity for formulating and deploying management techniques for quality data collection and integration into a centralized database, implementing secure procedures for data management and providing access to CAP-IT investigators for in-network sharing in accordance with the policies established by the CAP-IT SC.
3. Plans and capacity for functioning as the Program centralized data management center in close collaboration and coordination with each CAP-IT Center Informatics group throughout the award period.

Sub-section D. CAP-IT Shareable Resource Coordination

This section must address the following key aspects:

1. Plans for identifying and collecting information on shareable research tools and resources (e.g., novel assay technologies, protocols, preclinical biospecimens and agents) generated through the conduct of CAP-IT research in close communication and coordination with each CAP-IT Center PD(s)/PI(s) or their designated representative(s) in accordance with the policies established by the CAP-IT SC.
2. Plans and capacity for establishing a centralized information hub for the Program’s shareable tools and resources in accordance with the policies established by the CAP-IT SC.
3. Plans and capacity for establishing access protocols for these data to facilitate efficient sharing of unique resources and technologies among CAP-IT investigators and providing detailed instructions to the Program investigators on how to access the Program shareable resources information hub.

Sub-section E. Milestones and Adaptability

This section must describe specific milestones and measurable goals/benchmarks for the entire award period. Milestones are intermediate steps towards the completion of concrete goals. The milestones must be well-defined to serve as appropriate objective performance targets. The CAP-IT DRCC is also expected to evolve, adapt, and improve during the award period in response to the needs of the CAP-IT research community. Specifically, this section must address the following key aspects:

1. Measurable milestones as goals/benchmarks that will identify progress (or signal emergent difficulties).
2. For each milestone, appropriately detailed (quantitative) criteria by which milestone achievement can be assessed.
3. A detailed timeline for the anticipated attainment of each milestone and the overall goal (use of a Gantt chart is recommended).
4. Evidence that the proposed CAP-IT DRCC team will have the expertise and flexibility to accommodate increasing data volume and evolving data types.
5. Plans to improve the usability of the centralized research database and resources information hub by soliciting user feedback and/or analysis of usage. This plan should describe the frequency of these evaluations and how this information will be used to best serve the needs of the CAP-IT community.

• NCI requires applicants to submit electronically through Grants.gov. All applications (including those for multi-project activity codes) must be submitted electronically using a single-project application form package with the Competition ID of “FORMS-E-ADMINSUPP-RESEARCH”
• The process for Streamlined Submissions using the eRA Commons cannot be used for this initiative.

Administrative Review Process

NCI will conduct administrative reviews of applications submitted to their IC and will support the most meritorious applications submitted for consideration, based upon the availability of funds.

Criteria:

1. Does the administrative supplement address the CAP-IT DRCC requirements?
2. How well will the proposed CAP-IT DRCC contribute to the Program’s research objectives by serving as the network data and resources information hub and facilitating trans-network activities and cross-network collaborations?
3. Does the proposed Center’s vision and goals provide unique benefits and capacities to the CAP-IT Program?
4. Do the PD(s)/PI(s) have experience and accomplishments in overseeing data management for multi-institutional research programs focused on molecularly or immunologically targeted agent discovery and development?
5. Do the PD(s)/PI(s) have appropriate experience in program management and are their managerial and collaborative capabilities adequately supported?
6. How likely do the proposed approaches contribute to achieving the CAP-IT Program’s research objectives by functioning as the network information hub for research data and resources, providing program management support, enhancing in-network communications, and creating a synergistic research community?
7. Are the overall strategy and organization of the proposed CAP-IT DRCC and methods for data collection and integration and coordination with individual CAP-IT Center Informatics groups adequately developed, feasible, and appropriate to accomplish the specific goals of the CAP-IT DRCC?
8. Are the institutional infrastructure, facilities, equipment, and resource deployment strategies appropriate for the proposed CAP-IT DRCC to facilitate its mission and potential success? To what extent will these environment(s) help respond to the needs of the Program?

Applicants are strongly encouraged to notify the program contact at the Institute supporting the parent award that a request has been submitted in response to this NOSI to facilitate efficient processing of the application.

Inquiries

Please direct all inquiries to:

Scientific/Research Contact(s)

Shizuko Sei, M.D.
Division of Cancer Prevention
National Cancer Institute (NCI)
Telephone: 240-276-5005
Email: [email protected]

Financial/Grants Management Contact(s)

Amy Bartosch
National Cancer Institute (NCI)
Telephone: 240-276-6885
Email: [email protected]