publication date: May. 15, 2020

NCI BSA approves 11 new and reissue concepts, defers one

By Alexandria Carolan

The NCI Board of Scientific Advisors has approved 11 new and reissue concepts—Request for Applications, Cooperative Agreement, Request for Proposals, and Program Announcement with special receipt, referral and review.

The BSA voted to defer one concept, “Low-dose CT Lung Cancer Screening Image and Data Resource,” to a future meeting.

The presentations are available here.

The following concepts were presented at the May 12 meeting of the BSA.

 


Glioblastoma Therapeutics Network (RFA): Approved

The purpose of this RFA is to improve treatment of glioblastoma in adults by developing novel effective agents and testing them in the clinic.

The project will receive funding through the U19 grant.

The anticipated budget includes up to five U19 awards, with a 5-year project period. The budget for each award is $1.1 million, with $500,000 for one network coordination center. The budget also includes $6 million, set aside for the first year of the RFA. The total cost over 5 years is $30 million.

The RFA, submitted by the Division of Cancer Treatment and Diagnosis, will establish a national infrastructure to enhance support for discovery and development of glioblastoma therapies, with five areas of research capability:

  1. Preclinical qualification of new agents

  2. Clinical trials driven by molecular pharmacodynamics and imaging

  3. Immunotherapy

  4. Improving radiation therapy efficacy

  5. Improving the quality of life of patients

Key guidelines for the funding opportunity announcement include:

  • Focus on late Drug Discovery through phase I clinical studies

  • Possible agents include small molecules, biologics, and/or radiotherapy

  • Testing in animal models that closely mimic human adult glioblastoma

    • Extensive model development is outside scope

    • Models should include assessment of passage through BBB and ideally allow for repeated testing of tumors over the course of treatment

  • Aim for early-phase proof-of-mechanism clinical trials that include PK, PD and imaging; and include multiple clinical centers

    • Phase II and beyond is outside of scope

The implementation plan includes a national GBM Therapeutics Network (GTN) of crosscutting teams using the U19 mechanism. Each team would be capable of driving novel agents from the development stage through IND studies and into pilot clinical studies in humans, or; repurposing and testing approved agents and/or combinations (of new or repurposed agents, with targeted agents, immunotherapy, and/or standard-of-care—temozolomide and radiation—that appear to be efficacious in GBM). Teams would also conduct PD-driven clinical trials.

Measures of success for the program include:

  • Success of GTN at the end of a 5-year grant term must include trans-U19 clinical testing of one or more novel or repurposed agents. Agents may come from within the GTN or from outside (via the steering committee).

Other successful outcomes may include:

  • Promotion of one or more agents to IND stage, with plans for clinical testing after 5-year grant period

  • Preclinical development of one or more novel agents for GBM based on steering committee criteria for advancement to clinic; plans for IND submission after 5-year grant period

  • Preclinical development of combinations of novel agent(s) and standard-of-care therapy for GBM

 


Tobacco Cessation, HIV and Comorbidities in Low- and Middle-Income Countries (RFA): Approved

The goal of this RFA is to bring together transdisciplinary teams of investigators to adapt

interventions developed and tested in challenging or low-resource populations, and to test their robustness among people living with HIV/AIDS (PLWH) in low- and middle-income countries (LMICs).

This project is a global companion RFA to the domestic RFA—Improving Smoking Cessation Interventions among People Living with HIV (RFA-CA-18-027/28).

NCI’s Division of Cancer Control and Population Sciences submitted the RFA. The RFA will use appropriated NIH AIDS funds, and will seek co-funding and participation from the National Institute on Drug Abuse, National Institute on Minority Health and Health Disparities, and the Fogarty International Center.

The RFA anticipates funding through four or more R01/U01 grants. The estimated total budget is $12.5 million, of which $2.5 million will be set aside for year one.

The project will also build on previous NCI/NIDA PARs (PAR-18-22/23, R01/R21) “Tobacco Use and HIV in Low and Middle Income Countries.”

Research questions and goals include:

  • What types of tobacco cessation interventions are most effective in PLWH in low-resource settings in LMICs to achieve improved tobacco abstinence as well as disease treatment outcomes?

  • Test the robustness and translatability of interventions from challenging or low-resource settings (e.g. substance abuse or mental health comorbidities) to challenging settings of PLWH in LMICs.

  • Adapt innovative but tested strategies with potential for scale-up for PLWH in LMICs, including use of community health services, mobile technology, and behavioral counseling.

  • Identify and address barriers to integrating tobacco control interventions into existing health care systems and the HIV prevention and treatment context in LMICs.

  • Understand the social and behavioral context of tobacco use in PLWH in LMICs influence tobacco use behavior and cessation outcomes.

Reviewers will be asked to consider:

  • Prior evidence for the proposed intervention in a challenging population and/or low-resource setting (in the U.S. or LMIC),

  • Relevance of the expected findings for the LMIC setting,

  • Potential for the intervention to be scaled up in the LMIC setting; and

  • Strength of the research environment in both U.S. and LMIC institutions, as well as evidence of prior successful collaboration.

Also, studies should be designed for dissemination (e.g., feasibility/acceptability of the intervention for PLWH and providers) and suitable for the intended context.

 


Aging, Cancer-Initiating Cells, and Cancer Development (RFA): Approved

The purpose of this joint NCI-National Institute on Aging concept is to expand our limited understanding of age-driven mechanistic factors and cellular interactions that contribute to cancer initiation in aged cells, establish standards for assays, and develop new or improved aging models to study cancer initiation.

The RFA was submitted by NCI’s Division of Cancer Biology.

The project will be funded through the U01 grant. Applications for the U01 grant will be solicited over two receipt dates. Awardees and NCI staff will form a consortium to develop best practices, novel approaches and model systems.

The estimated budget is $10 million for the total project period, with $2 million per year that includes three to four applications. The NIA will fund an additional 5-6 U01 projects, and will set aside $3 million for year one. The estimated total cost for NIA over the project period is $15 million.

Up to five years of funding can be requested, and each application must include a model of aging and cancer. Review will be conducted by an NCI special emphasis panel to assure both aging and cancer expertise

The project will use paired funds from NCI and NIA.

The project will also support collaborative studies between cancer and aging researchers that address limited understanding of mechanistic factors and cellular interactions during aging, which contribute to cancer initiation.

Portfolio Analysis

A recent portfolio analysis (from FY2010-FY2020) using “cancer,” and “aging” as

keywords identified 251 awarded R01 grants (NCI -134, NIA -117). The majority of NCI grants are focused on investigating mutations, DNA damage and inflammation while NIA grants are more focused on longevity, homeostasis, senescence, and metabolism.

Only a small portion (11 NCI, 4 NIA) is relevant to this proposal and focused on mechanisms of aging and cancer development. There are no funding opportunity announcements, supporting grants or supplements for this research focus right now.

Examples of research areas:

  • Identifying novel age-related genes and proteins, epigenetic modifications and/or metabolomic changes that promote cancer initiation,

  • Identifying roles of senescence and novel age-related nonautonomous factors including those of the niche and inflammaging that regulate cancer initiation,

  • Understanding how age-related factors are interrelated; and

  • Developing new or unique age-related cancer models to study aging and their niches that lead to oncogenesis. Studies may include cell models developed from aging tissues such as organoids, induced pluripotent stem cells from aging tissues, and others.

 


SBIR Contract Topics (RFP): Approved

The purpose of the SBIR Contract Topics RFP is to provide 17 small business innovation research contract topics with funding in FY21. These will be awarded through SBIR grants.

There was no associated budget for this concept, which was submitted by the Office of the Director.

The SBIR and the Small Business Technology Transfer programs support commercially-directed research and small businesses, with the end goal of delivering a topic to the marketplace. In FY19, NCI allocated $175 million for SBIR and for these two programs. Most of these funds are used for investigator-initiated grants.

NCI develops these topics once per calendar year, which are approved by NCI leadership, the Cancer Moonshot program leadership, and BSA. NCI is the biggest user of SBIR contracts at NIH.

The topics presented were originally 22 ideas submitted by NCI staff, reflecting NCI technology priority areas including Cancer Moonshot topics, areas with commercial potential, and portfolio gaps. The concepts were presented to and discussed by two NCI internal technology advisory groups covering key NCI mission areas: Therapeutics, diagnostics, radiation therapy, medical devices, information technology, and behavioral products.

These two staff committees vetted the concepts for significance, innovation, and commercial potential of the proposed products. In the end, staff recommended 17 topics for publication, and these were recently approved by NCI leadership. The 17 topics are broken into five categories:

  1. Therapeutics

  2. Medical devices

  3. Diagnostics

  4. IT

  5. Manufacturing

Eight of the 17 are aligned with the Cancer Moonshot initiative. These were approved by the NCI Moonshot Implementation Steering Committee. The 17 concepts follow:

Therapeutics

  • Next generation 3D tissue culture systems with tertiary lymphoid organs: Submitted by the Division of Cancer Biology, Division of Cancer Treatment and Diagnosis, Center for Strategic Scientific Initiatives, SBIR Development Center, and Division of Cancer Control and Population Sciences. The goal is to fund development for IO research purposes of in vitro culture systems for these human lymph node-like structures that form in response to chronic inflammation. This concept is aligned with Cancer Moonshot recommendation J, development of new enabling cancer technologies for 3D organ-like cultures.

  • Synthetic biology gene circuits for cancer therapy: Submitted by SBIR Development Center. The goal is to stimulate the engineering of advanced cancer therapies with gene transfer of artificial synthetic biology signaling pathways.

Medical Devices

  • Applicator-compatible electronic brachytherapy sources for cancer radiotherapy: Submitted by the Division of Cancer Treatment and Diagnosis. The goal is to develop implantable electronic radiation sources with off switches, free of natural radiation sources.

  • Self-sampling devices for HPV testing-based cervical cancer screening: Submitted by the Division of Cancer Prevention and SBIR Development Center. The goal is to develop user-friendly, high cellular-yield devices to allow women to self-collect cervicovaginal samples for HPV testing.

Clinical Diagnostics and Molecular Analysis

  • Quantitative imaging software tools for cancer diagnosis and treatment planning: Submitted by the Division of Cancer Treatment and Diagnosis. The goal is to commercialize new or existing academic quantitative imaging software for use by radiologists for common cancer imaging modalities.

  • 3D spatial omics for molecular and cellular tumor atlas construction: Submitted by the Division of Cancer Biology, Center for Strategic Scientific Initiatives, and SBIR Development Center. The goal is to provide development for research purposes of scalable imaging technologies that will provide both 3D tumor architecture and single cell -omics information. This topic is aligned with Moonshot Recommendation I, on the generation of human tumor atlases.

  • Understanding cancer tumor genomic results—technology applications for providers: Submitted by the Division of Cancer Treatment and Diagnosis, Division of Cancer Control and Population Sciences, Center for Global Health, and SBIR Development Center. The goal is to develop software to assist oncology providers in communicating genomic testing results to patients without a genetic counselor. This topic is aligned with Moonshot Recommendation A, establishing a network for direct patient engagement.

  • Single cell “unbiased discovery” proteomic technologies: Submitted by the Division of Cancer Treatment and Diagnosis, Division of Cancer Control and Population Sciences, Center for Strategic Scientific Initiatives, and SBIR Development Center. The goal is for the development for research purposes of proteomic biomarker discovery approaches, to quantify >1,000 proteins in a typical cell. This topic is aligned with Moonshot Recommendation J, development of new enabling cancer technologies; molecular analysis technologies, and mass cytometry for individual cells.

Information Technology and Bioinformatics

  • Software to address social determinants of health in oncology practices: Submitted by the Division of Cancer Control and Population Sciences and SBIR Development Center. The goal is to create IT tools to support systematic assessment of social determinants of health, and appropriate referral and follow up in oncology practices. This topic aligns with the Moonshot cross-cutting theme on reducing cancer health disparities.

  • Digital tools to improve health outcomes in pediatric cancer survivors: Submitted by SBIR Development Center and the Division of Cancer Control and Population Sciences. The goal is to create software to support delivery of high quality cancer survivorship care for children/adolescents.

Manufacturing Technologies

  • Advanced manufacturing to speed availability of emerging autologous cell-based therapies: Submitted by the Division of Cancer Treatment and Diagnosis and SBIR Development Center. The goal is improved cell processing methods to expedite and reduce the cost of producing cell-based therapies.

Topics from FY20 to be reissued

  • Quantitative biomimetic phantoms for cancer imaging and radiation dosimetry: Submitted by the Division of Cancer Treatment and Diagnosis.

  • Spatial sequencing technologies with single cell resolution for cancer research and precision medicine (Moonshot): Submitted by the Division Cancer Treatment and Diagnosis and SBIR Development Center.

  • IT tools for automated analysis of physical activity, performance, and behavior from images for improved cancer health: Submitted by the Division of Cancer Control and Population Sciences.

  • Tools and technologies for visualizing multi-scale data (Moonshot): Submitted by the Center for Strategic Scientific Initiatives and Division of Cancer Biology.

  • De-identification software tools for cancer imaging research: Submitted by the Center for Biomedical Informatics and Information Technology.

  • Cloud-based multi-omic and imaging software for the cancer research data commons (Moonshot): Submitted by the Center for Biomedical Informatics and Information Technology.

 


NCI SBIR Innovative Concept Award to Develop Transformational Solutions Focused on Prevention, Detection, Treatment, and Research in Pediatric Cancer and Rare Cancers (RFP): Approved

The purpose of this RFP is to support small businesses developing highly innovative and transformative technologies that have the potential to create new scientific paradigms, establish entirely new and improved clinical approaches to significantly improve cancer research, prevention, detection and care for pediatric or rare cancers.

The RFP was submitted by The Office of the Director. The concept award will be funded by the SBIR program.

The concept award, a 3-year pilot, will have one receipt date per year in the pilot round. The total estimated cost per year is $1.5 to $3 million. The RFP will fund five to 10 awards at around $300,000 each, for one year. Awardees will be in the phases 0-I of research. Clinical trials are not permitted in the program.

Standard SBIR eligibility criteria apply.

Examples of projects and activities the RFP could fund, but are not limited to: 

  • New mechanisms of action

  • New targets

  • Innovative drug delivery

  • AI-driven prognostics/diagnostics tool

Why SBIR?

  • Proposal components can be modified,

  • Applications require shorter proposals (15 to 20 pages with three pages for research strategy),

  • One to two page letter of intent will be reviewed for responsiveness by NCI program directors,

  • Review allows for more emphasis on innovation, allows modification of review criteria weightage unlike the omnibus grant mechanism,

  • Assess scientific rationale given the preliminary data,

  • NCI DEA Special Review Panel with mix of academic industry venture and biotech

  • Quarterly reporting,

  • Payment based on achieving milestones.

 


Cancer Intervention and Surveillance Modeling Network (CISNET) Incubator Program for New Cancer Sites (RFA/Coop. Agr.): Approved

The purpose of the CISNET Incubator Program RFA/Coop. Agr. is to translate CISNET’s model of success to cancer sites for which there has been nascent or limited population modeling efforts to date and little to no comparative modeling.

CISNET currently uses a comparative modeling approach with three to six independent modeling groups per cancer site. The project includes one multiple PI grant per cancer site with a coordinating center. Notably, CISNET has helped the United States Preventive Services Task Force create screening guidelines in cervical cancers.

The RFA/Coop. Agr. was submitted by The Division of Cancer Control and Population Sciences.  The project will be funded through the U01 grant.

The estimated budget is $4 million per year, with a total of $20 million over five years. The budget includes $180,000 direct cost per modeling group (two to three per cancer site), $90,000 for the coordinating center, $40,000 costs contribution to a junior investigators program, and four awards.

The incubator program:

  • Includes multiple PI grants with 2-3 independent modeling groups that will share common data sources and compare their models as they are developed.

  • One modeling group that will serve as the coordinating center for that site

    • Formulating, prioritizing, and coordinating work;

    • Negotiating common requests for outside data sources;

    • Preparing inputs and collecting and processing common outputs for model comparisons / critical evaluation of disparate results.

  • Require that no more than one PI on an incubator application can also be a PI on a concurrently funded CISNET grant.

What the project is looking for:

  • Up to the research community to make the case that a cancer site is amenable to this type of modeling and would have impactful public health benefits.

  • Searching for cancer site specific proposals where:

    • Applicants bring together separate nascent modeling efforts focusing on important cancer control applications,

    • Data sources exist to inform the models (especially the preclinical natural history)

    • Potential interventions or strategies are sufficiently well developed to provide estimates of their operating characteristics; and

    • Priority will be given to applications that propose modeling feasible cancer control opportunities at different points across the cancer control spectrum.

The CISNET Incubator will focus on the same priority areas as the main CISNET RFA, but new incubator sites will spend considerable time on model development/refinement and consideration and study of data sources to inform the models.

Nine priority areas:

  1. Precision Screening and New Screening Technologies

  2. Precision Treatment

  3. Overdiagnosis and Active Surveillance

  4. Decision Aids (Individual and Policy)

  5. Understanding Screening in Real-World Settings and Determining the Best Routes to Optimize the Processes

  6. State, Local, and International Cancer Control Planning

  7. Suggesting Optimal Routes to Reduce Health Disparities

  8. Methods Development

  9. Cancer Site-Specific Opportunities

State of population modeling in cancers beyond the six included in CISNET

  • Fewer existing models, and not as well developed,

  • Because of a lack of consistent funding, most are “one-off” efforts that focus on a single limited portion of cancer control spectrum,

    • Importance of including synergies across the spectrum,

  • No (or very limited) comparative modeling,

    • Some post publication comparisons of models and results—difficult to do because of so many things varying simultaneously;

  • Availability of new data resources to inform models; and

    • Large observational databases and specialized linkages, e.g. linkage between SEER hepatocellular carcinoma cases and state hepatitis registries.

 


Pediatric Preclinical Testing Public-Private Partnership (PPTP3) (Reissue RFA/Coop. Agr.): Approved

The purpose of this reissue RFA/Coop. Agr. is to establish an in vivo testing program and coordinating center for the in vivo testing program for the Preclinical Testing Public-Private Partnership. Future NCI components include a high throughput in vitro testing program and data commons.

The reissue concept was submitted by the Division of Cancer Treatment and Diagnosis.

The estimated budget for the partnership is $3.7 million in direct costs for year one, and $5.9 million in total costs for year one. The in vivo testing program is estimated to be $3.2 million in direct costs and $5.1 million in total costs. The coordinating center is estimated to be $500,000 in direct costs, and $800,000 in total costs. The cost of the in vitro testing program and data commons is to be determined.

NCI PPTP3 in vivo testing program (inVivoTP)

  • Plans for eight awards for research programs for in vivo testing.

  • Open competition for in vivo testing sites with plans to encourage applications from new research teams.

  • Agnostic in terms of models (e.g., PDX in immunodeficient mice, murine genetic models engineered to reflect the characteristics of specific pediatric cancers, and murine syngeneic models).

  • Potential disease areas of focus include: ALL, AML, neuroblastoma, osteosarcoma, rhabdomyosarcoma, Ewing sarcoma, renal and hepatic tumors, and CNS tumors.

  • Each team anticipated to test eight to 10 agents per year.

  • Plan for broader utilization for single-mouse trial design for agents for which tumor-regressing activity is sought.

  • Selection criteria to include:

    • Number and breadth of models proposed and the extent to which the proposed tumor panels faithfully recapitulate key biological characteristics of molecularly defined subtypes of specific pediatric cancers

    • Scientific leadership that the research team is anticipated to bring to the PPTP3 and its Scientific Advisory Committee

    • Ability to conduct testing with required throughput

PPTP3 Coordinating Center components

  • Administrative management, logistics, and coordination of in vivo testing sites,

  • Establishment of a confidential and private project information site,

  • Development of quality assurance/quality control procedures,

  • Management of laboratory specimens and a biospecimen tracking system,

  • Coordination of shipments of compounds supplied by companies to testing sites,

  • Collection, analysis and storage of testing data from the testing sites,

  • Preparation of technical study reports for agents tested through the PPTP3; and

  • Collaboration with research programs in developing, presenting, and publishing manuscripts.

PPTP3 Data Commons goals (future RFA)

  • To aggregate/federate and analyze genomic, proteomic, and epigenomic characterization data for cell lines and PDX models from both PPTP3 research teams and from external research teams,

  • To aggregate/federate and analyze genomic, proteomic, and epigenomic characterization data for clinical specimens to establish as comprehensive a dataset as possible to facilitate robust comparisons to preclinical data,

  • To aggregate, store, and compare existing and new testing data both from PPTP3 research teams and from external research teams,

  • Provide analyses of genomic, proteomic and epigenomic data to support decision making for preclinical evaluations and for clinical development plans; and

  • Make data available in ways that are easily accessible by the research community.

 


International Agency for Research on Cancer (IARC) Monographs Program (Reissue RFA/Limited Competition): Approved

The goal of the International Agency for Research on Cancer Monographs Program is to evaluate cancer agents including chemicals, biological agents, occupational exposures and lifestyle factors.

NCI has supported the IARC Monographs program since 1982, through a U01 grant. The reissue RFA, which will be funded through the R01 grant, was submitted by the Division of Cancer Biology.

The estimated total cost per year is $900,878 over five years—$4.5 million total.

An advisory group consisting of senior health policy and environmental researchers meets every five years to prioritize agents for consideration for the monographs program for the next five-year cycle. The group prioritizes agents on the extent of human exposure, suspicion of carcinogenicity, public health concern and new, relevant studies.

The IARC Monographs program is a unique NIH award. There are two carcinogen identification programs in the United States: A report on Carcinogens (National Toxicology Program, National Institute of Environmental Health Sciences), Integration Risk Information System (Environmental Protection Agency).

The IARC Monographs program considers a broader number and type of agents to evaluate. The program evaluates agents of global concern, especially in low and middle income countries.

Monograph process

  • Working Groups review literature comprehensively

    • Subject matter experts: interdisciplinary, international

    • Evaluate epidemiology, animal studies and mechanism data

    • Summarize exposure data

  • Determination of agent as a cancer hazard

    • Known, probable, or possible carcinogen, not classifiable

  • Three Working Groups per year (NCI funds two)

    • Volumes freely available as PDFs

    • Over 1,000 agents evaluated by 125 Working Groups

Agents

  • Recently evaluated

    • High concern: engine exhaust, red meat and outdoor air pollution

    • Low and middle income countries (LMIC): malaria, hepatitis B and C viruses, indoor combustion/cooking

  • New and high priority for 2020-2024

    • Bisphenol A, cytomegalovirus, e-cigarettes and nicotine, disinfection byproducts and cannabis smoking

 


Low-dose CT Lung Cancer Screening Image and Data Resource (RFP): Deferred

The purpose of this RFA is to create a new LDCT lung cancer screening image library to make screening more efficient and reduce screening-related harms, the false-positive rate must be substantially reduced, while leaving test sensitivity essentially unchanged.

One approach to reduce the false-positive rate is through development of artificial intelligence and machine learning tools to assist radiologists in interpreting LDCT screening and diagnostic images.

The RFA was submitted by the Division of Cancer Prevention. The RFP is a five year contract. The estimated cost is $4.5 million for the collection of data and images, and set-up for image storage for up to three years. Image storage and dissemination is expected to cost $500,000 per year for up to three years. Image validation set activities, including qualification as a MDDT for two years is $500,000 to $1 million.

The majority of the BSA voted to defer the concept, citing concerns that it’s unclear how the composition of the library is designed to address false positive rates, and that there should be more prescriptive description of the diversity of the population with respect to smoking status, comorbidities, race and ethnicity.

NCI program staff will work on this concept in the meantime, which will be considered by the BSA at a future meeting so long as Scientific Program leadership agrees.

The RFP would:

  • Have a new LDCT lung cancer screening image library obtained with current LDCT technology and in standard clinical (non-research) settings,

  • Include diagnostic f/u CT images include demographic, screening outcome and clinical outcome (lung cancer incidence) data,

  • Not require enrolling/consenting of patients: only retrospective collection of de-identified images and data,

  • Be made available to the research community through a controlled process; and

  • Hold back a subset of images for algorithm validation.

Project scale:

  • 15,000 unique subjects

  • 22,500 screening LDCT images

  • 6,000-8,000 diagnostic CT images

  • 1,500 subjects with lung cancer-associated image (diagnosed within 18 months of a screen)

  • 9,000 subjects with Lung-RADS positive screen (no cancer)

  • 4,500 subjects with (only) Lung-RADS negative screens (no cancer)

 


Social and Behavioral Intervention Research to Address Modifiable Risk Factors for Cancer in Rural Populations (PAR): Approved as RFA

The BSA voted to approve this concept as an RFA, rather than a PAR, as was originally submitted to the board. NCI’s Division of Extramural Activities will review the RFA as approved.

The purpose of the social and behavioral intervention concept is to solicit applications to develop, adapt, and test individual, community, or multilevel interventions to address modifiable risk factors for cancer in rural populations (defined as USDA RUCC or RUCA non-metropolitan areas or FAR rural areas).

The concept was submitted by The Division of Cancer Control and Population Sciences. There was no associated grant or budget.

Proposals should:

  • Focus on primary prevention, targeting one or more of the modifiable risk factors that contribute to cancer disparities in rural populations, and

  • Assess and address myriad social determinants of health, cultural factors, policies, and health care and technology access barriers that may contribute to rural cancer disparities.

This FOA encourages implementation science research, to incorporate efficacious cancer control interventions into broader, sustainable health programs that are designed to reach rural populations and allow local customization and adaption.

Applicants are strongly encouraged to collaborate with organizations and programs with experience or infrastructure (e.g., telemedicine, behavioral health services) designed to address other health or social problems in rural populations that could afford substantial opportunities to cancer prevention and control investigators.

Examples include, but are not limited to, Federally Qualified Health Centers, community health centers, rural health centers, and community organizations.

Example applications may target:

  • Behavioral risk factors for cancer in rural populations (primary outcomes)

    • Tobacco use

    • Diet, Physical Activity, and Weight

    • Alcohol consumption

    • UV exposure and sun-protective behavior

    • HPV vaccination

  • Social determinants and structural/system characteristics that contribute to rural disparities in behavioral risk factors for cancer (secondary outcome measures or mediators of effect)

    • Economic and spatial barriers to healthy food access and/or physical activity in low density rural environments,

    • Technology, communication, and health information inequalities that may contribute to cancer disparities in rural populations.

Study designs

The RFA is labeled “Clinical Trial Required” to solicit intervention applications that meet the NIH definition of a clinical trial:

  1. Human subjects

  2. Prospectively assigned to one or more interventions

  3. Health-related biomedical or behavioral outcome

These are not drug or device trials. Applications may propose either pragmatic or explanatory trials to test effects in real-world/usual conditions or under ideal/controlled conditions (e.g., experimental or quasi-experimental study designs).

Applications may propose individual, clinic, and/or community-level units of analysis (individuals or cluster randomization).

 


Cancer Moonshot Concepts:


3D Technologies to Accelerate HTAN Atlas Building Efforts (HTAN #1) (RFA/Coop. Agr.): Approved

The purpose of this project is to facilitate rapid implementation of promising new technologies for time-efficient, three dimensional molecular characterization of intact human tumor tissue for dynamic 3D tumor atlas construction.

The RFA/Coop. Agr. was submitted by the Office of the Director.

The RFA/Coop. Agr will be funded through the UH2 grant, and will integrate with existing Human Tumor Atlas Network U2C and U24 grants. The project will include three to four UH2 grants.

The total cost for all years of the project is around $3.3 million for four grants. The estimated budget for the project is $250,000 per year, with a duration of two years.

Applications

  • PIs with relevant expertise are encouraged to apply. Non-HTAN grantees are expected to be part of HTAN and encouraged to use HTAN-procured biospecimens.

  • Applications require preliminary data demonstrating the “shovel-readiness” of the technology in an HTAN-relevant tumor will be required.

This is an HTAN-focused program that leverages and complements other NIH and NCI imaging efforts.

Integration with existing HTAN network

  • Leverage shared HTAN tumor sources via trans-network efforts (currently colon, breast),

  • Encourage identification of collaborators within HTAN-funded research centers,

  • Agree to data use and sharing policies,

  • Deposit data, protocols and SOPs with the HTAN Data Coordinating Center; and

  • Participate in relevant HTAN working groups and biannual face-to-face meetings.

 


Cancer Moonshot Data Visualization Methods and Tools Development (R33) (NET #1) (RFA): Approved

The purpose of this RFA is to stimulate the development of new cancer data visualization tools that have the potential to make data from Cancer Moonshot areas more explorable and interpretable by the broader cancer research community.

This RFA was submitted by The Office of the Director.

The R33 funding opportunity is for the development of new visualization tools and approaches addressing Cancer Moonshot-aligned use cases and priorities. Award lengths are up to four years. The direct cost is expected to be $250,000 per year. The total cost for all years is $5 million.

The R33 RFA:

  • Is open to applications from all investigators,

  • Is investigator-identified use cases, user communities, and insights to be gained,

  • Includes proposed tools that will enable visualization of Cancer Moonshot data addressing the specified use case and user community; and

  • Has an expectation of tool validation studies.

Applicants should:

  • Identify a data visualization use case aligned to Cancer Moonshot and specify a targeted user community that is currently underserved by existing data visualization tools,

  • Propose the development of a data visualization software tool that addresses the use case, the insights to be gained for the user community, and

  • Describe plans for validation of the proposed tool(s), and plans for community engagement.

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