PURPOSE

The St. Baldrick’s Foundation and the American Cancer Society are collaborating to provide funding to advance innovative translational pediatric cancer research conducted within the context of a clinical trial. Studies may include analysis of clinical data and biospecimens collected from children enrolled in a clinical trial.

Together, these contribute to a plethora of important, unanswered questions that extend beyond primary objectives of the clinical trial. For example: Why are some cancers more aggressive than others? What distinguishes variable treatment response rates? Why does cancer vary significantly by the age of child? Which children are at high risk for long-term effects of treatment?

To accelerate progress in childhood cancer research, a deeper understanding of the biologic and physiologic mechanisms specific to these diseases and their treatment is needed, as are better ways to personalize care and improve quality of life.

By leveraging the resources and infrastructure of approved clinical trials, we aim to maximize the knowledge we can gain from the data, the biospecimens, and the clinical information collected, to improve outcomes for children more quickly.

SCIENTIFIC SCOPE

Areas of interest: Proposals should focus on research leading to improvements in the care of children with cancer. Potential research areas include:

• Monitoring disease response
• Predicting clinical outcomes
• Analyzing the tumor microenvironment, the role of germline and/or somatic mutations in tumor pathogenesis
• Identifying or validating predictive or prognostic biomarkers
• Developing pre-clinical novel therapeutic targets
• Improving the anti-tumor activity of immunotherapy or other emerging therapies
• Mitigating and managing side-effects
• Improving quality of life

This list is not comprehensive, but research topics of interest include:

• How can a more in-depth understanding of cancer biology in children advance care
  How can the similarities and differences of cancer types by age, gender, race/ethnicity and socioeconomic factors be used to inform care? Are common or newly identified genes and other biomarkers potential targets for prevention, early detection, treatment or indicators of good or poor prognosis or relapse? What is the role of the microbiome and how does that change during treatment or as children age?

• Why are some pediatric cancers unresponsive to treatment?
  What biological mechanisms and gene alterations are involved in both intrinsic and acquired resistance to various therapies?

• How can we reduce treatment toxicity?
  Explore pathways leading to toxicities of therapies that damage organ systems or impair physical or cognitive development.

• How can we improve the cancer experience for patients and families?
  Novel strategies to: evaluate and improve experience of children with cancer and their families, refine or develop more effective patient reported outcomes measures, test strategies to mitigate side effects or improve symptom burden, or use technology to quantify and manage symptoms.

See these press releases about projects previously funded under this RFA:

• Grants funded in 2021
• Grants funded in 2022

GRANT MECHANISMS, ELIGIBILITY, AND BUDGET

ALL research proposals must be coupled with on-going or recently completed, approved pediatric clinical therapeutic trial, such as large/definitive trials conducted in a cooperative group setting. Activation of Awards will be dependent upon activation of the clinical trial (if it has not started) and approval by the lead PI of the trial.

Pilot Accelerator Awards are intended to include high risk/high reward research that tests feasibility and generates preliminary data to open new and highly innovative areas of investigation. For example, validation of prognostic or predictive biomarkers, establishing the feasibility of conducting a clinically integrated or integral molecular test in a CLIA/CAP environment, or pilot testing a strategy to improve quality of life.

Eligible Investigators: Must have a doctoral-level degree and have a full-time faculty position or equivalent at a college, university, medical school, or eligible not-for-profit research organization within the United States. There are no citizenship restrictions.

Eligible Institutions: Applications may be submitted by a college, university, medical school, or other eligible not-for-profit research organization within the United States, its territories, and the Commonwealth of Puerto Rico.

Grant Term and Budget: The award is for a 2-year term with $100k direct cost per year, plus 20% allowable indirect cost.

Letter of Intent Process: A letter of intent (LOI) is required and will be used to determine which investigators are invited to submit proposals. LOI materials are available on proposalCENTRAL.

The LOI is submitted as an abstract in proposalCENTRAL (3,100 characters maximum, including spaces) The abstract should include:

• Approved Clinical Trial Information: Title, number, and PI name
• Brief background for the research plan
• Specific aims and hypothesis
• Data elements required
• Cohort inclusion/exclusion criteria
• Study design
• Data analysis plan
• Expected significance and impact

Additional requirements:

• Description of the study team, including the names and roles of each member
• NIH biosketches  for the PI and study team

Invitation-to-Apply Decisions: After review of the LOIs, invitation-to-apply decisions will be communicated to applicants via proposalCENTRAL. Once applicants are invited to apply, their application will be created and available in their proposalCENTRAL account under “active proposals.”