PAR-25-145
Clinical Characterization of Cancer Therapy-induced Adverse Sequelae and Mechanism-based Interventional Strategies (R01 Clinical Trial Optional)
Summary
Clinical Characterization of Cancer Therapy-induced Adverse Sequelae and Mechanism-based Interventional Strategies
Research Focus
This R01 Clinical Trial Optional program supports research addressing long-term adverse effects from cancer therapies—including chemotherapy, radiation, immunotherapy, targeted therapies, and hormonal treatments—that persist as chronic comorbidities or emerge as delayed posttreatment effects. The NCI seeks projects that identify mechanistic underpinnings of therapy-induced adverse sequelae, clinically characterize these effects, and translate mechanistic insights into preventive or mitigating interventions. Research may span basic science, translational, and clinical settings. Priority areas include clinical phenotyping of chronic or progressive adverse events; investigation of adverse sequelae trajectories; development and validation of objective measures (biomarkers, imaging, patient-reported outcomes); risk stratification; and translational prevention or mitigation strategies. Specific adverse effects of interest include therapy-induced peripheral neuropathy, neurocognitive impairments, cardiovascular toxicity, lymphedema, pulmonary fibrosis, fatigue, nephrotoxicity, ototoxicity, and immune-related adverse events. Collaborations coupling mechanistic knowledge with clinical phenotype are prioritized; preclinical studies should validate findings in human tissue or human-derived cells.
At a Glance
- Who can apply: Not stated (see standard NIH R01 eligibility)
- Funding & project length: Not stated in excerpt
- Award mechanism: R01 Research Project Grant (clinical trial optional)
- Key dates: Open January 5, 2025; multiple submission deadlines through January 8, 2028; earliest start dates range from December 2025 to July 2028 depending on submission cycle
- Best fit for: Oncology, cancer survivorship, toxicology, and translational medicine researchers investigating chronic or late-onset treatment-related toxicities in adult or pediatric cancer populations using mechanistic and clinical phenotyping approaches
Key Facts
Deadline
Fri, January 7, 2028
Posted
Wed, November 6, 2024
Award / Year (direct costs)
$250,000
Max Total
$1,250,000
Max Duration
5 years
Keywords
Research Areas
Gotchas (3)
Applications must comply with both the Application Guide AND this NOFO, with program-specific instructions taking precedence. However, the specific program-specific deviations from standard R01 instru
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Source Text
“It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the NOFO) is required and strictly enforced. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.”
The NOFO explicitly lists four categories of non-responsive applications that will not be reviewed, including studies on acute/reversible adverse sequelae and preclinical models of non-FDA approved ag
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Source Text
“Applications with the following attributes will be deemed non-responsive and will not be reviewed. 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; and Exploring the development of symptomatic adverse events in non-cancer conditions.”
The NOFO was updated to align with agency priorities and applicants are explicitly warned to 'carefully reread the full funding opportunity' before submission, suggesting material changes from the pri
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Source Text
“This funding opportunity was updated to align with agency priorities. Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission.”