Key Dates
Release Date: January 9, 2020
Request Receipt Due: March 31, 2020
Earliest Anticipated Start Date for Awards: July 1, 2020
Purpose
The National Cancer Institute (NCI) announces an opportunity for supplemental funding in support of projects that utilize biospecimens from the AIDS and Cancer Specimen Resource (ACSR)* inventory (or another certified biorepository); data from existing cohorts; and/or biospecimens and clinical data from the Cancer Center itself, including international partnerships of the Center. The primary goal of this initiative is to stimulate research in AIDS defining (ADCs) and non-AIDS defining cancers (NADCs) at the NCI-designated Cancer Centers (CC). This effort is aimed to expand the knowledge base of HIV/AIDS cancer pathogenesis, etiology, early detection, treatments, and cures. It is intended that discoveries from this effort will inform and guide the development of novel diagnostic, preventive and therapeutic strategies for AIDS-defining and/or non-AIDS defining cancers.
All NCI-Designated Cancer Centers are eligible for funding. A letter of intent is not required; a full proposal of no more than 6 pages must be submitted by the request receipt date to the NCI Office of Cancer Centers. Funding is contingent upon NCI approval of the proposal, which will include both a scientific and budgetary evaluation. Only one supplement will be allowed per institution. The research proposal should address questions that can be tested by using biospecimens and/or cohort data.
Background
Mortality among people living with HIV/AIDS decreased substantially with the introduction of combination antiretroviral therapy (cART). However, treatment might not fully reverse the effect of early immune suppression and immune dysfunction, and chronic inflammation can persist among people receiving cART. Individuals with HIV infection are now living longer and cancer is a leading cause of mortality among them. There is a substantial decrease in the incidence of ADCs (Kaposi sarcoma, non-Hodgkin lymphoma, cervical cancer), and an increasing incidence of NADCs, such as Hodgkin disease, lung, liver and anal cancers. Additionally, with prolonged survival of the HIV population, the effect of HIV-related immunosuppression in an aging population is unclear.
There were approximately 37.9 million people across the globe with HIV/AIDS in 2018. An estimated 1.7 million individuals worldwide became newly infected with HIV in 2018. In the USA, 1.1 million people are living with HIV. The new HIV infections in the USA have declined to approximately 38,739 new cases a year (2017), most occur among a few groups such as African American and Hispanic/Latino gay and bisexual men, and African American heterosexual women living in the Southern United States.
Scope
Specific areas of study may include, but are not limited to, the following examples:
• Discovery of reliable molecular and immunological diagnostic and prognostic biomarkers and pathogen markers, useful for early detection, progression, or response to treatment of non-AIDS-defining and AIDS-defining cancers
• Discovery and development of novel targets and efficacious new therapeutic agents, interventional strategies, or improved delivery systems for the treatment of persons afflicted with non-AIDS-defining and AIDS-defining cancers
• Studies to develop biomarker and diagnostic assays from a wide spectrum of AIDS-defining and non-AIDS defining cancers
• Studies to determine the cellular genome, transcriptome, epigenome, proteosome and metabolome of virally induced and other tumors in the context of HIV infections
• Studies to determine the effects of prolonged moderate immunosuppression and/or incomplete or failed responses to cART on the development of either non-AIDS-defining or AIDS-defining cancers
• Studies aimed at understanding the molecular pathogenesis of AIDS defining as well as non-AIDS-defining HIV-associated cancers
• For a given HIV-associated tumor type (e.g. lung cancer), studies aimed at understanding similarities and differences between the tumors arising in HIV-infected and uninfected individuals, understanding differences in their pathogenesis and establishing similarities and differences in various body sites
Eligible Institutions
Cancer Centers whose P30 CCSG will be in a cost-extension at the time the award is made in FY20 are not eligible for this supplement.
Number of Applications
Only one application per institution is allowed. Each application must include a cover letter from the NCI-Cancer Center Director with concurrence from the Authorized
Organization Official (AOR).
Letter of Intent
A letter of intent is not required for this supplement.
Terms and Conditions of Funding and Allowable Costs
The budget should justify all the direct and indirect costs. Supplements are for 2 years only, although a one-year no-cost extension will be allowed. We anticipate that up to 8 to 9 awards of no more than $250,000 total cost each will be made in the 2020 fiscal year. Any proposal that cannot be completed within the 2-year time frame will be viewed as non-responsive. Allowable costs include funding for the Project Leader of the study (maximum of 20% effort), who must be a member of the NCI-designated cancer center; funding for required expertise to complete this project; and costs for supplies. The purchase of large pieces of equipment through this supplement will not be permitted.
Supplement Award Application Procedures
1. Cover Letter
A cover letter should accompany each application and include the following:
a. Request for an administrative supplement to support the project
b. Title of the supplement
c. P30 grant number
d. Contact information for the Cancer Center Director and the Project Leader
e. Signatures of the Cancer Center Director and the Authorized Organization Representative (AOR)
2. Application
a. Standard PHS 398 (pages: 1-5)
i. Item 2: check yes and provide the title indicated in the cover letter, 1.b.
ii. Item 7A-8B, denote the direct and total costs for the project.
iii. The AOR must sign the face page.
iv. Include a detailed budget description.
v. Provide NIH biographical sketches for the P30 Principal Investigator and the Project Leader.
3. Summary of the Project Proposed
The applicant should attach a summary of the project including a description of aims; specific approach to be used to complete this project; investigators; and environment where the work will be performed. A full budget with justification should be included. A statement of how the proposed project would meet the NIH HIV/AIDS Research Priorities as listed in the NOT-OD-15-137. It should explain which high priority topic or topics will be addressed. General projects focusing, for example, on EBV, HPV, KSHV or other oncogenic viruses or HIV alone are not eligible for support under this supplement award.
4. Justification of Staff
Provide NIH biographical sketches of all key personnel.
Note that in order to qualify for a supplement, the name of the Project Leader must be proposed at the time of submission.
Application Submission
Applications may be submitted as a signed, scanned PDFs to Ms. Nga Nguyen at nga.nguyen2@nih.gov by 5:00 p.m. (local time) on the receipt date.
Evaluation Criteria
Supplements will be administratively evaluated by NCI staff with appropriate expertise. There will not be a secondary review process.
Awards
Awards will be based on responsiveness to the goals of this announcement and the availability of funds.
Reporting Requirements
As part of the annual progress report of the parent NCI Cancer Center Support Grants include information on what has been accomplished via the administrative supplement during the funding period. A copy of the annual progress report for the administrative supplement should also be sent to Dr. Hasnaa Shafik by email at shafikh@mail.nih.gov.
Questions
Please contact Dr. Hasnaa Shafik (telephone: 240-276-5600; Email: shafikh@mail.nih.gov) for questions related to the supplement.
* The NCI-funded ACSR is a national/international repository of specimens that have been collected from HIV-infected individuals and HIV-negative controls. The specimens and associated data are made available to the research community-at-large at NO COST. For more details please visit ACSR inventory explorer at https://acsr.ucsf.edu/inventory-explorer/ 2