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Notice of Special Interest (NOSI): Improving Outcomes in Cancer Treatment-Related Cardiotoxicity
Notice Number:
NOT-CA-22-001

Key Dates

Release Date:

November 4, 2021

First Available Due Date:
February 05, 2022
Expiration Date:
November 06, 2024

Related Announcements



PA-20-183 - NIH Research Project Grant (Parent R01 Clinical Trial Required)
PA-20-185 - NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed)
PAR-20-052 - NCI Small Grants Program for Cancer Research (R03 Clinical Trial Optional)
PAR-20-077 - NCI Program Project Applications (P01 Clinical Trial Optional)
PAR-20-292 - NCI Clinical and Translational Exploratory/Developmental Studies (R21 Clinical Trial Optional)
PAR-21-035 - Cancer Prevention and Control Clinical Trials Grant Program (R01 Clinical Trial Required)
PAR-21-190 - Modular R01s in Cancer Control and Population Sciences (R01 Clinical Trial Optional)
PAR-21-329 - Clinical Characterization of Cancer Therapy-induced Adverse Sequelae and Mechanism-based Interventional Strategies (R01 Clinical Trial Optional)
PAR-21-341 - Exploratory Grants in Cancer Control (R21 Clinical Trial Optional)

Issued by

National Cancer Institute (NCI)

National Heart, Lung, and Blood Institute (NHLBI)

Purpose

The purpose of this Notice of Special Interest (NOSI) is to encourage collaborative and innovative approaches to mitigate cardiovascular dysfunction while optimizing cancer outcomes by understanding the mechanisms of cancer treatment-related cardiotoxicity and translating the findings to improve risk stratification, early detection, prevention, and management.

Background

There are nearly 17 million pediatric and adult cancer survivors living in the United States today and this number is expected to rise to 22 million by 2030. This is due to the continued impact of the dramatic improvements in recent anti-cancer treatment efficacy. Unfortunately, the overall success of cancer treatments has been dampened by a parallel rise in the incidence of cancer treatment-related cardiovascular toxicity, leading to morbidity and mortality. Cardiovascular toxic anticancer treatments, including cytotoxic chemotherapy, targeted and immunomodulatory agents, and radiation, are used in single and combination treatment regimens across numerous cancer types. Cancer treatment-related cardiotoxicity can occur due to direct effects on cardiac myocytes (function or protective mechanisms), damage to the vascular endothelium, hemodynamic flow alterations, and altered thrombogenicity. Cardiotoxicity presents acutely during cancer treatment, potentially limiting dose and reducing the effectiveness of cancer treatment, as well as decades after treatment, leading to increased morbidity and early mortality due to accelerated treatment-induced cardiovascular disease. Given the heterogeneity among patients with respect to cardiotoxicity risk, timing of onset, clinical presentation, and outcome, understanding and translating mechanisms and biomarkers into individualized cardio-oncology risk stratification, early detection, prevention, monitoring, and management during cancer treatment and survivorship care is of utmost importance, and are currently lacking. Current guidelines addressing cancer treatment-related cardiotoxicity are broad, based mainly on anthracyclines and suffer from a poor level of evidence for individual risk evaluation, prevention, monitoring, and management strategies for new and emerging cancer treatment approaches.

This NOSI will foster collaborations among oncology and cardiology researchers and encourage innovative approaches to: 1) improve understanding of mechanisms of cardiovascular dysfunction attributed to distinct cancer treatments in order to develop new therapeutic strategies for cardioprotection; 2) develop pre-clinical models and methods to identify potential adverse cardiovascular outcomes in drug development studies; 3) differentiate and quantify characteristics associated with short- and long-term cardiotoxicity; 4) develop and test methods to detect early-onset cardiovascular dysfunction; and 5) develop, test, and evaluate novel approaches to prevention, management, and care coordination strategies for cardiotoxicity.

Research Objectives

NCI and NHLBI are interested in grant applications with oncology and cardiology collaborative approaches that address the research gaps as outlined in Shelburne, et al. 2014 and 2019. Applications addressing pediatric and adult needs are of interest. These include, but are not limited to, those that:

  • Improve understanding of mechanisms and biomarkers, including genetic factors, of cardiovascular dysfunction attributed to cancer treatments.
  • Validate use of biomarkers, imaging, or functional measures as surrogate endpoints to surveil, and assess therapy and management of cancer treatment related cardiotoxicity.
  • Develop pre-clinical models (e.g., both in vitro and in vivo animal models) and methods to identify potential adverse cardiovascular outcomes in cancer drug development studies.
  • Identify and characterize the cancer treatment-related cardiovascular adverse events that occur anytime during the cancer survivorship continuum (from cancer diagnosis to death).
  • Translate knowledge of known and emerging clinical and genetic profiles and biologic mechanisms of cardiotoxicity pathogenesis into improvements in cardiotoxicity risk stratification, prevention, and detection.
  • Develop, test, and validate prevention and management strategies for cancer treatment-related cardiotoxicity.
  • Focus on the specific needs of understudied and underserved cancer populations and emerging cancer treatments.

Responsiveness for both NCI and NHLBI

  • Applications that are responsive to the NOSI include multidisciplinary collaborations across cardiology and oncology.

NHLBI

  • NHLBI only permits mechanistic clinical trials [see PA-20-183, NIH Research Project Grant (Parent R01 Clinical Trial Required)]

Application and Submission Information

This notice applies to due dates on or after February 5, 2022, and subsequent receipt dates through November 06, 2024.

Submit applications for this initiative using the following funding opportunity announcement (FOA) or any reissues of these announcements through the expiration date of this notice:

Activity Code FOA Title First Available Due Date Expiration Date Participating IC
PA-20-183 NIH Research Project Grant (Parent R01 Clinical Trial Required) February 5, 2022 May 08, 2023 NHLBI
PA-20-185 NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed) February 5, 2022 May 08, 2023 NHLBI, NCI
PAR-20-052 NCI Small Grants Program for Cancer Research (R03 Clinical Trial Optional) February 24, 2022 January 08, 2023 NCI
PAR-20-077 NCI Program Project Applications (P01 Clinical Trial Optional) January 25, 2022 May 08, 2023 NCI
PAR-20-292 NCI Clinical and Translational Exploratory/Developmental Studies (R21 Clinical Trial Optional) February 22, 2022 July 21, 2022 NCI
PAR-21-035 Cancer Prevention and Control Clinical Trials Grant Program (R01 Clinical Trial Required) February 5, 2022 January 08, 2024 NCI
PAR-21-190 Modular R01s in Cancer Control and Population Sciences (R01 Clinical Trial Optional) March 7, 2022 March 08, 2024 NCI
PAR-21-329 Clinical Characterization of Cancer Therapy-induced Adverse Sequelae and Mechanism-based Interventional Strategies (R01 Clinical Trial Optional) February 5, 2022 November 06, 2024 NCI
PAR-21-341 Exploratory Grants in Cancer Control (R21 Clinical Trial Optional) June 07, 2022 October 09, 2024 NCI

All instructions in the SF424 (R&R) Application Guide and the funding opportunity announcement used for submission must be followed, with the following additions:

  • For funding consideration, applicants must include NOT-CA-22-001 (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.

Applications nonresponsive to terms of this NOSI will not be considered for the NOSI initiative.

Inquiries

Please direct all inquiries to the contacts in Section VII of the listed funding opportunity announcements with the following additions/substitutions:

Scientific/Research Contacts

Nonniekaye Shelburne, MS, CRNP, AOCN
National Cancer Institute (NCI)
Telephone: 240-276-6897
Email: [email protected]

Bishow B. Adhikari, PhD
National Heart, Lung, and Blood Institute (NHLBI)
Phone: (301) 435-0504
E-mail: [email protected]

Peer Review Contact(s)
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)

Crystal Wolfrey
National Cancer Institute (NCI)
Telephone: 240-276-6277
Email: [email protected]

Fatima Kamara
National Heart, Lung, and Blood Institute (NHLBI)
Phone (301) 435-7916
Email: [email protected]


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