Notice of Special Interest (NOSI): Research on HIV-associated Malignancies NOT-CA-23-070 is sponsored by National Cancer Institute (NCI). This NOSI calls for proposals that seek to identify specific contributions of HIV infection and its potential interaction with other oncogenic pathogens on the development and pathogenesis of these cancers, including studies that provide new information on the clinical outcomes …

Expired NOT-CA-23-070: Notice of Special Interest (NOSI): Research on HIV-associated Malignancies This notice has expired. Check the NIH Guide for active opportunities and notices.

Notice of Special Interest (NOSI): Research on HIV-associated Malignancies First Available Due Date: New Date September 9, 2025 (Prior Date May 10, 2023 - HIV-associated Non-Communicable Diseases Research at Low- and Middle-Income Country Institutions (R21 Clinical Trial Optional). See NOFO PAR-23-191 . May 07, 2020 - NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Not Allowed).

See NOFO PA-20-195 . May 05, 2020 - NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed). See NOFO PA-20-185 .

National Cancer Institute ( NCI ) Through this Notice of Special Interest (NOSI), the National Cancer Institute (NCI) intends to continue advancing our understanding of the risks, development, progression, diagnosis, and treatment of malignancies observed in individuals with an underlying human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS), which are now a leading cause of death in people with HIV (PWH).

This NOSI calls for proposals that seek to identify specific contributions of HIV infection and its potential interaction with other oncogenic pathogens on the development and pathogenesis of these cancers, including studies that provide new information on the clinical outcomes of such cancers in the HIV-infected population.

Ultimately, such efforts could guide development of targeted screening approaches and therapies optimized for PWH. AIDS research as described in the Office of AIDS Research (OAR) priorities is encouraged in areas such as the study of the etiologic factors, cofactors, immunopathogenesis, diagnosis, and outcomes of cancer in populations with an underlying HIV infection.

The purpose of this NOSI is therefore aligned with OAR priorities for AIDS research and is specifically launched to foster cancer-focused research that addresses important gaps in knowledge for the control and treatment of cancer and cancer-related comorbidities among PWH.

This is a continuation of NOT-CA-20-022, "High" or "Medium" Priority AIDS Research on Non-AIDS-defining or AIDS-defining Cancers, which expired on January 8, 2023 , and is entitled, “Research on HIV-associated malignancies ” to reflect the most recent Office of AIDS Research priority guidelines for R21 and R01 mechanisms.

NCI continues to encourage research that advances our understanding of the risks, development, progression, diagnosis, and treatment of malignancies observed in individuals with an underlying HIV infection and will continue to support research efforts that identify specific contributions of HIV infection on (a) the pathogenesis of co-infecting oncogenic pathogens, (b) the development of infectious cancer and associated disease sequelae of cancer, (c) investigations of modifiable factors/environmental exposures in diverse populations at risk for HIV-associated cancers, and (d) the clinical outcomes of such cancers in PWH.

Ultimately, such efforts could guide development of targeted screening approaches and therapies optimized for PWH. Early in the epidemic, the most common tumors in PWH were those associated with severe immunosuppression, most notably Kaposi sarcoma (KS), non-Hodgkin lymphoma (NHL), and invasive cervical cancer.

Widespread use of combination antiretroviral therapy (cART) and the aging of PWH, have somewhat caused a shift in the trends of the tumors associated with HIV infection to now include a wider spectrum of tumors, including anal cancer, several types of lung cancers, hepatocellular carcinoma, nasopharyngeal carcinoma, and Hodgkin lymphoma.

Under the current Office of AIDS Research priority guidelines , research to reduce HIV-associated co-infections, comorbidities such as cancer, and other complications, is aligned with OAR priorities for HIV/AIDS research agenda. Therefore, through this NOSI, NCI intends to foster cancer-focused research in this area and to address recently identified research gaps included in the OAR priority guidelines.

Specific areas of research on HIV-associated malignancies may include but are not limited to: Etiology, Pathogenesis, and Immunology Studies of how aging and/or neurological disease processes and HIV interact in the development of cancer; Studies to characterize the cellular inflammasome, epigenome, proteome, metabolome, glycobiome, and transcriptome of tumors in the context of HIV infection; Studies investigating HIV-associated alteration of the microbiome, metabolome, and/or virome and its impact on cancer; Mechanistic studies of how immune responses, the tumor niche, or pathogenic processes of co-morbidities interact with HIV to induce tumor initiation and/or support tumor promotion; Studies that incorporate novel digital technologies (e.g., telehealth, wearables, implantable sensors, mobile apps, etc.) with Artificial Intelligence (AI)/Machine Learning (ML) applications to better determine epidemiological predictions, cancer risks, speed of diagnosis and treatment to improve cancer outcomes in the context of HIV-associated cancers in underserved populations; S tudies identifying modifiable risk factors and environmental exposures (e.g., chemical, physical, and biological agents) and their effects on underlying HIV acquisition and associated malignancies in diverse populations; and Development of animal and/or cell-based models for understanding the biology and pathogenesis of cancer in the context of an underlying HIV infection.

Biomarkers, Diagnostics, and Therapeutics Discovery of reliable molecular and immunological diagnostic and prognostic biomarkers and pathogen markers, useful for early detection, progression, or response to treatment for cancer in individuals with an underlying HIV infection; Studies of anti-cancer immunotherapy modalities in PWH and/or the comparative responses between PWH versus people without an underlying HIV infection; Studies using existing cohorts and tissue banks of human specimens from a wide spectrum of tumors from people with an underlying HIV infection to develop biomarkers, diagnostic assays, or analyze samples and data acquired from these cohorts.

Examples of such cohorts and repositories include: AIDS and Cancer Specimen Resource (ACSR ), MACS/WIHS Combined Cohort Study (MWCCS) Veterans Aging Cohort Study (VACS) International epidemiology Databases to Evaluate AIDS (IeDEA) Molecular Epidemiology and Prevention Studies to determine the relationship of “-omics” data to the natural history of cancer in the context of an underlying HIV infection; Studies to characterize the immunologic, virologic, genetic, and epigenetic differences between people on cART who develop pre-neoplastic and neoplastic conditions and people who resolve these conditions or do not develop them; Studies to characterize the host genetic susceptibility to cancer with an underlying HIV infection and the host factors contributing to cancer development; Studies to assess risk factors (e.g., tobacco, cannabis, infections, social determinants of health, diet, and nutrition) that impact cancer in different geographic locations in both domestic and international settings.

Application and Submission Information This notice applies to due dates on or after September 7, 2023 and subsequent receipt dates through September 8, 2026. Submit applications for this initiative using one of the following notice of funding opportunity (NOFO) or any reissues of these announcement through the expiration date of this notice.

R01 NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed) Sept 7, 2023 R21 NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Not Allowed ) Sept 7, 2023 R21 HIV-associated Non-Communicable Diseases Research at Low- and Middle-Income Country Institutions (R21 Clinical Trial Optional) Sept 7, 2023 All instructions in the SF424 (R&R) Application Guide and the notice of funding opportunity used for submission must be followed, with the following additions: For funding consideration, applicants must include “NOT-CA-23-070” (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. Although NCI is not listed as a Participating Organization in all the NOFOs listed above, applications for this initiative will be accepted. Applications nonresponsive to terms of this NOSI will be withdrawn from consideration for this initiative.

Please direct all inquiries to the contacts in Section VII of the listed notice of funding opportunity with the following additions/substitutions: Scientific/Research Contact(s) For basic science research : Elizabeth Read-Connole, Ph. D. National Cancer Institute (NCI) For research on malignant complications of HIV/AIDS : Geraldina Dominguez, Ph.

D.

National Cancer Institute (NCI) For research on malignant complications of HIV/AIDS : National Cancer Institute (NCI) For epidemiologic research and digital epidemiology (including AI/ML subfields) : National Cancer Institute (NCI) For research on epigenetics in the topic area: National Cancer Institute (NCI) Telephone: (240) 276-6889 Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Financial/Grants Management Contact(s) National Cancer Institute (NCI) Weekly TOC for this Announcement NIH... Turning Discovery Into Health ®