Key Dates

Related Announcements

PAR-20-077 - National Cancer Institute Program Project Applications (P01 Clinical Trial Optional)

Issued by

National Cancer Institute (NCI)

Purpose

Purpose

The purpose of this Notice of Special Interest (NOSI) is to encourage P01 Research Program Project applications designed to address adverse sequelae of cancer therapies (including chemotherapy and radiation) that persist and become chronic comorbidities or develop as delayed posttreatment effects. The research focus of proposals should build upon mechanistic studies and include clinical phenotyping of adverse sequelae, the development and implementation of prevention or mitigation strategies, and validation of pre-clinical biomarkers in the clinical setting. Proposals should be focused on clinical and translational research supported by preliminary mechanistic research.

Background

The number of cancer survivors has increased to an estimated 16 million with a projected increase to 22 million by 2030. Systemic cancer treatment can result in acute, cumulative, progressive, and/or chronic toxicities that may have a profound impact on quality of life for cancer survivors. The trajectory of adverse events, particularly those that are progressive, chronic, and/or late onset, is difficult to define due to a lack of objective measures of treatment related adverse effects, insufficient characterization of the clinical phenotype, and a dearth of studies validating pre-clinical biomarkers in the clinical setting. Often, pre-treatment baseline assessments are inadequate, impairing the ability to understand individual variability and sub-clinical risk factors. Further, it is unknown how age, race/ethnicity, and co-morbid conditions will affect the development, progression, or severity of adverse events. In some cases, it is not a single adverse event, but a cluster of events that may herald the development of significant sequelae. For most of the known cancer treatment-related adverse effects, no approved mitigation therapies or evidence-based management strategies are in place.

Given the high prevalence and significant impact of cancer treatment-related adverse effects, there is a need to understand both the mechanisms for their acute development and the clinical trajectory of the events that become chronic sequalae, including the variability in severity and duration of specific chronic or late effects.

Research Objectives

NCI is interested in grant applications that extend the mechanistic understanding of cancer therapy induced adverse sequelae to address one or more of the research gap areas outlined below. Program Projects should address hypotheses supported by mechanistic data through projects focused on clinical and translational outcomes. Applications may focus on adverse sequelae that persist and become chronic co-morbidities or develop as delayed posttreatment effects related to radiation and/or systemic therapy (chemotherapy, immunotherapy, targeted or hormonal therapies). Research areas of interest include, but are not limited to:

• Clinical characterization/phenotyping chronic or progressive cancer therapy induced adverse events or cluster of events
• Investigation of the trajectory of adverse sequelae that progress or become chronic
• Development or validation of objective measures of treatment related adverse events
• Validation of clinical markers (biomarkers, imaging, patient-reported outcomes) of adverse sequelae in the clinical setting
• Conducting early-phase clinical trials to evaluate prevention or mitigation strategies

P01 Research Program Project applications should include at least three related research projects that share a common theme and overall objective focused on chronic or progressive cancer therapy induced adverse events. Project aims should be complementary and synergistic to others in the program. The individual projects should be interrelated, so the results provide a greater contribution to program goals than if the projects were pursued separately. An example would include one project each that focuses on 1) clinical phenotyping and development of objective measures for chemotherapy induced peripheral neuropathy (CIPN), 2) validation of clinical biomarkers of CIPN, 3) early phase clinical trial evaluating mitigation strategies utilizing measures or markers developed in projects 1 and 2 for CIPN.

Responsiveness

The following types of study are not responsive to the intent of the NOSI:

• Studies focused on acute, reversible, and non-progressive adverse sequelae
• Exploring resistance to cancer treatment
• Using pre-clinical models to determine adverse events of non-FDA approved anti-cancer agents
• Exploring the development of adverse events in non-cancer conditions

Application and Submission Information

This notice applies to due dates on or after January 25, 2021, and subsequent receipt dates through May 8, 2023.

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

• PAR-20-077: National Cancer Institute Program Project Applications (P01 Clinical Trial Optional)

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-22-005 (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

Scientific/Research Contact(s)

Kelly Filipski, PhD, MPH
National Cancer Institute
Telephone: (240) 276-6841
Email: Kelly.Filipski@nih.gov

Alexis Bakos, PhD, MPH, RN
National Cancer Institute
Telephone: (301) 921-5970
Email: Alexis.Bakos@nih.gov

Peer Review Contact(s)

Referral Officer
National Cancer Institute (NCI)
Telephone: 240-276-6390
Email: ncirefof@dea.nci.nih.gov

Financial/Grants Management Contact(s)

Shane Woodward
National Cancer Institute (NCI)
Telephone: 240-276-6303
Email: Woodwars@mail.nih.gov