Notice of Intent to Publish a Notice of Funding Opportunity for National Cancer Institute's Specialized Programs of Research Excellence (SPOREs) in Cancer Health Disparities and Minority Health (U54 Clinical Trial Optional)

Key Dates

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National Cancer Institute (NCI)

The National Cancer Institute (NCI) intends to issue the U54 Specialized Programs of Research Excellence in Cancer Health Disparities and Minority Health (CHD-MH SPORE) notice of funding opportunity (NOFO). The program will support a network of multidisciplinary, multi-institutional U54 CHD-MH SPOREs, which are multi-project awards uniquely focused on health disparities and/or minority health translational research for improved prevention, early detection, diagnosis, and treatment of cancer in populations who are underserved. U54 CHD-MH SPOREs can investigate more than one cancer type in underserved populations, including groups of highly related cancers (e.g., gastrointestinal or head and neck). The research supported through this program must be translational and must stem from research on human biology, addressing the interplay of various determinants of health with the biology of the disease. U54 CHD-MH SPORE projects must have the goal of reaching a translational human endpoint within the project period of the grant, which may include a clinical trial.

This Notice of Intent to Publish is being provided to allow sufficient time for applicants to develop strong applications.

The NOFO is expected to be published in late winter 2024 with only one expected application due date in late September 2024.

This NOFO supports a collaborative network of SPOREs, under the U54 cooperative agreement mechanism, that is uniquely focused on CHD-MH translational research in populations who are underserved. Populations who are underserved are NIH-designated populations with health disparities, including Black, Hispanic/Latino, Indigenous and Native American persons; Asian Americans, Native Hawaiians, and Pacific Islanders; lesbian, gay, bisexual, transgender, and queer (LGBTQ+) persons; persons with lower socioeconomic status (SES); persons with disabilities; and persons who live in rural areas. Applicants are encouraged to focus on cancer types for which health disparities are particularly well documented, including cancers of the breast, prostate, lung, gastrointestinal systems, cervix, endometrium, head and neck, liver, lung, and kidney, as well as leukemia and myeloma. Although studies involving these cancers are strongly encouraged, other cancer types can be included if a disparity or disparities population is appropriately justified. Unlike minority health projects, proposed CHD projects must include a reference or comparator group to assess disparities in cancer outcomes. However, the identified reference group would be based on the scientific rationale or question proposed and is not by definition required to be non-Hispanic White.

The goals of the proposed research may vary widely and address for example:

• Discovery, validation, and assessment of how various determinants of health intersect with the biology of cancer to affect cancer incidence, diagnosis, treatment, early detection, and prevention in populations who are underserved.
• Characterization of the biological impact of social determinants of health and identifying specific biological pathways that might be targeted by clinical or public health interventions.
• Hypothesis generating studies characterizing risk factor prevalence or biological differences in populations who are underserved.
• Investigating the role of determinants of health and comorbidities on toxicity to therapeutic interventions in populations who are underserved.

U54 CHD-MH SPOREs comprise the following required components:

• A minimum of three translational research projects, each with a human endpoint, must be proposed. Clinical trials are optional and may be proposed as a human endpoint. E ach project must include at least one basic and one applied/clinical co-leader.
• An Administrative Core which describes the SPORE's organization and capabilities, including organizational, administrative, scientific, and clinical trial management within the SPORE. This component should explain, at the overall program level, how coordination, communication, and diverse perspectives will be achieved among the different projects and programs, Shared Resources Cores, and participating institutions. This Core will also include activities of the required Community Advisory Board (CAB).
• A Community Outreach and Engagement (COE) Shared Resources Core and a Biospecimen/Pathology Shared Resources Core. SPOREs also have the option to include other Shared Resources Cores that provide laboratory and/or clinical facilities, equipment, and/or services to be shared by one or more research projects and developmental programs (e.g., a Biostatistical Core). Shared Resources Cores within the SPORE should not duplicate any shared resource facilities that are already available to the research group but may build upon these facilities for unique capabilities required by the SPORE.
• A Developmental Research Program (DRP) to support pilot projects focused on new research opportunities in CHD-MH. The pilot projects may be collaborative among scientists within one or more SPOREs, or with scientists outside the SPORE community. High-risk/high-payoff pilot projects are especially encouraged. These pilot projects are not required to reach a human endpoint during the project period.
• A Career Enhancement Program (CEP) to support investigators who wish to enhance or refocus their careers on translational cancer research and are proposing a cancer health disparities or minority health research project. CEP recipients are expected to interact with SPORE-associated translational research advisors to guide the project and monitor progress.
• Scientific Collaborations (within the Overall component) demonstrating a commitment to both horizontal and vertical collaborations with investigators outside of the SPORE to complete preclinical projects and move promising results along the pathway of translational/clinical development.
• A minimum research base of four or more independent investigators who currently serve as PDs/PIs (or project leaders) on peer-reviewed research grants or are overall/site chairpersons on an active NCI-sponsored clinical trial. These activities must be directly related to the cancer(s) being investigated in the SPORE or the specific expertise required for the SPORE, including CHD-MH. The qualifying investigators also must serve on the SPORE as a PD/PI, a multi-PD/PI, project co-leader or Shared Resources Core director.

U54 CHD-MH SPOREs will be expected to establish the critical research infrastructure needed to sustain the translational research projects, collaborations, and community outreach and engagement proposed within the U54 SPORE network. This will include intra- and inter-U54 CHD-MH SPORE activities, such as patient accrual; engagement with community advocates and stakeholders; sharing of resources, methodology, and best practices; and participation in U54 CHD-MH SPORE network meetings.

Non-responsive applications

This NOFO will not support:

• Applications lacking a cancer health disparity or minority health focus.
• Applications that do not have access to underserved populations/biospecimens that are the focus of the application.
• Applications that do not propose translational research and do not include appropriate human endpoints.
• Projects lacking a laboratory component to investigate or understand the biology of human cancer.
• Applications that do not meet the Minimum Research Base of four or more independent investigators who currently serve as PDs/PIs (or project leaders) on peer-reviewed research grants or are overall/site chairpersons on an active NCI-sponsored clinical trial directly related to the cancer(s) being investigated in the SPORE or the specific expertise required for the SPORE, including CHD-MH.

These applications will be deemed not responsive to this NOFO and will not be reviewed.

Funding Information

Public/State Controlled Institution of Higher Education
Private Institution of Higher Education
Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education)
Small Business
For-Profit Organization (Other than Small Business)
State Government
Indian/Native American Tribal Government (Federally Recognized)
County governments
Independent school districts
Public housing authorities/Indian housing authorities
Indian/Native American Tribally Designated Organization (Native American tribal organizations (other than Federally recognized tribal governments)
U.S. Territory or Possession
Indian/Native American Tribal Government (Other than Federally Recognized)
Regional Organization
Eligible Agencies of the Federal Government

Applications are not being solicited at this time.

Inquiries

Please direct all inquiries to:

Leah Hubbard, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-5693
Email: [email protected]