Key Dates

Related Announcements

• October 9, 2020 - Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional). See PA-20-272.

Issued by

National Cancer Institute (NCI)

Purpose

The Division of Cancer Prevention (DCP) at the National Cancer Institute (NCI) announces the opportunity for current NCI grant awardees or cooperative agreement program participants to collaborate with the NCI Cancer Prevention-Interception Targeted Agent Discovery Program (CAP-IT) Specialized Centers to support the CAP-IT Program research. Collaborations should be proposed by investigators, who are not currently CAP-IT Center investigators (non-CAP-IT investigators) and whose research scope, interests and activities as specified in the parent awards are within the CAP-IT Program’s research objectives. All potential applicants are encouraged to contact the NCI Program Director to discuss the planned collaboration and application.

These supplements will achieve the following:

• Support the CAP-IT Program research by establishing collaborative projects between CAP-IT Specialized Centers and non-CAP-IT investigators.
• Inform non-CAP-IT research communities of the CAP-IT Program research initiatives.
• Build CAP-IT Program extra-network collaborations with non-CAP-IT research communities.

Background

While much progress has been made in the development of new or improved methods of determining 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.

Beginning with the earliest stage of tumor formation through the establishment of fully invasive cancers, oncogenesis is a continuum of dynamic interplay between emerging aberrant cell clones and the host tumor surveillance machineries. Better understanding of the early oncogenic processes and surveillance machineries can shed light on molecular physiological changes that are responsible for driving progressive tumor growth and weakening the host defense mechanisms. Biological and molecular events and changes in tumor precursor cells as well as in the tissue microenvironment can potentially tilt the balance for or against tumor growth. Some of these events may serve as oncotargets that can be exploited.

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 aims 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 Program was launched in 2022 initially with two U54 Centers, where a total of four CAP-IT projects are being carried out presently. Additional Centers are expected to join the CAP-IT network in 2023.

Eligibility

• Awardees/Applicants must be investigators, who are not currently CAP-IT Center investigators (non-CAP-IT investigators) and hold an active NCI grant or cooperative agreement, whose research scope, interests, and activities as specified in the parent awards are within the CAP-IT Program’s research objectives.
• Awardees/Applicants must demonstrate the CAP-IT Program collaborator(s)’ concurrence on the proposed collaborative projects by attaching a letter of support from the collaborating CAP-IT Specialized Center(s)’ principal investigators.
• To be eligible, the parent award must be able to receive funds in FY23 and be active throughout the one-year project period. The parent award must not be in an extension period (e.g., cost or no-cost extension).
• Early Stage Investigators (ESIs) are encouraged to apply.
• 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.
• Collaborations with foreign institutions are allowed, but investigators must provide a justification for the collaboration. Please note that some foreign collaborations will require U.S. State Department approval by the NCI, and that may delay receipt of funding. 

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-20-272 must be followed, with the following additions:

• Application Due Date: Submissions must be received by July 6, 2023 at 5:00 PM local time of applicant organization for FY 2023 funding.
• For funding consideration, applicants must include “NOT-CA-23-064” (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-23-064.”
• The process for Streamlined Submissions using the eRA Commons cannot be used for this initiative.
• The Research Strategy section of the application is limited to 6 pages and should address the following:
  • The administrative supplement addresses the NOSI requirements.
  • The proposed administrative supplement activities are relevant to the parent grant and its original scope.
  • How the proposed collaboration with CAP-IT Center(s) will contribute to the CAP-IT Program's research objectives. 

Budget and Period of Support

• Supplement budget requests must reflect the actual needs of the proposed one-year project and should not exceed a total cost of $200,000 per year (maximum direct cost is $120,000 per year) for the entire project.
• At least one full year on the parent grant must remain at the time of funding. The supplement application budget is limited to one year only.
• Requests for no-cost extensions on the parent grant to accommodate a supplement will not be permitted.
• The administrative supplement awards pursuant to this opportunity are contingent upon the availability of funds from NCI and the receipt of a sufficient number of meritorious requests. 

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. Additionally, NCI program staff will evaluate applications using the following selection factors:

1. Are the scope and implementation plans included in the proposed collaboration realistic, given the time and budget requested?
2. Do the PD(s)/PI(s) have appropriate experience in successfully leading collaborative projects?
3. Are the institutional infrastructure, facilities, equipment, and resource deployment strategies appropriate for the proposed collaboration?

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. Applicants are also encouraged to contact the NCI CAP-IT Program to discuss the planned collaboration and application.

Inquiries

Please direct all inquiries to:

Shizuko Sei, M.D.
Division of Cancer Prevention
National Cancer Institute (NCI)
Telephone: 240-276-5005
Email: seis@nih.gov

John Clifford, Ph.D.
Division of Cancer Prevention
National Cancer Institute (NCI)
Telephone: 240-276-5611
Email: john.clifford@nih.gov

Vignesh Gunasekharan, Ph.D.
Division of Cancer Prevention
National Cancer Institute (NCI)
Telephone: 240-276-5814
Email: vignesh.gunasekharan@nih.gov

Grants Management Contact

Crystal Wolfrey 
National Cancer Institute (NCI)
Telephone: 301-496-8634
Email: wolfreyc@mail.nih.gov