Notice of Special Interest (NOSI): Administrative Supplements for the Use of Existing Body Composition Data to Understand Treatment-Related Outcomes in Clinical Trials and Observational Studies

Notice Number: NOT-CA-20-036

Key Dates
Release Date: March 25, 2020
First Available Due Date: May 15, 2020
Expiration Date: May 16, 2020

Related Announcements
PA-18-591 Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)

Issued by
National Cancer Institute (NCI)

Purpose

This Notice of Special Interest informs current awardees that the National Cancer Institute (NCI) is inviting administrative supplement applications that seek to utilize existing measures of body composition (e.g., Computed Tomography (CT) scans) to better understand the associations with systemic cancer therapies (i.e., chemotherapy, immunotherapy, hormonal therapy, and targeted therapies) and adverse events, progression, and/or survival. Body composition is defined as the proportions of fat and lean mass, which includes muscle, bone, and water. Eligible studies must include high-quality treatment data that include dose received for all modalities and robust adverse event reporting.
These supplements will achieve the following:

  • Demonstrate the feasibility of using existing measures of body composition to add value to existing studies of cancer survivors, and
  • Expand the knowledge about how body composition may mediate treatment-related adverse events and survival.

Background

Through these administrative supplements, the NCI seeks to expand the information available about how body composition (i.e., the proportions of fat and lean mass) may help explain common adverse events of systemic cancer therapies. Chemotherapy is typically dosed according to body surface area (BSA), but there is substantial variation in body composition at a given BSA or body mass index (BMI). Varying levels of muscle and adipose may affect the pharmacokinetics of systemic cancer therapies, resulting in life-threatening toxicities from overdosing or poor disease outcomes from underdosing. Including measures of body composition will allow for dose calculations per cm2 of muscle to analyze whether body composition is associated with adverse events, progression, and/or survival.

To date, many studies of cancer patients have not included body composition measures because they were too expensive or not readily available. However, many patients have CT scans for clinical indications that could include lumbar vertebrae views (e.g., third lumbar vertebrae), which can be used for body composition analysis, as the skeletal muscle and adipose tissue in this region approximate the whole-body. Furthermore, there are a number of automated algorithms for computed body composition analysis for CT scans that provide cost-effective and efficient analysis (expert review is still required, but much less costly than manual segmentation for each record).

This supplement announcement supports data preparation of existing sources of body composition data and investigations of how body composition may be associated with the treatment dose received and adverse events, progression, and/or survival. Priority will be given for studies that investigate toxicities that may influence dose adjustment, as well as studies with diverse populations that are likely to encompass a range of muscularity.

Application and Submission Information

Applications for this initiative must be submitted using the following opportunity or its subsequent reissued equivalent.

PA-18-591 - Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)

All instructions in the SF424 (R&R) Application Guide and PA-18-591 must be followed, with the following additions

Eligibility:

  • Administrative supplement applications are limited to currently funded projects supported by the NCI.
  • PDs/PIs must hold an active eligible R01, R37, P01, U19, U01, or UM1 grant supported through NCI - no other grant mechanisms are eligible for this program.
  • For supplements to parent awards that include multiple PDs/PIs, the supplement may be requested by any or all of the PDs/PIs (in accordance with the existing leadership plan) and submitted by the awardee institution of the parent award.
  • Study must have existing source of body composition data (e.g., CT scans, dual-energy X-ray absorptiometry). This supplement will not support conducting new body composition assessments to collect these data.
  • Study design may be interventional or observational, but high-quality treatment data that includes dose received for all modalities of treatment is essential.

Application Due date: Submissions must be received by May 15, 2020 at 5:00 PM local time of applicant organization for FY 2020 funding.

Budget and Period of Support:

  • The budget should not exceed $150,000 in total costs.
  • At least one full year on the parent grant must remain at the time of funding. The application budget is limited to one year only. Funds from this supplement must be expended within 12 months of the supplement award issue date.
  • Requests for no-cost extensions on the parent grant to accommodate a supplement will not be permitted.
  • All proposed work must be within the scope of the original project of the eligible parent award, but only activities that were not originally proposed in the budget of the parent grant are eligible for supplemental funding.
  • Salary support for the PI(s) and collaborators may be considered with strong justification. Salary for general study oversight is not permitted.

Submitting Applications:

  • Applicants should begin the supplement application abstract by stating “This application is being submitted in response to the Notice of Special Interest (NOSI) identified as NOT-CA-20-036.”
  • In order to facilitate efficient processing of the request, applicants are strongly encouraged to notify Dr. Joanne Elena (joanne.elena@nih.gov), as well as the assigned NCI program officer for the parent award that a request has been submitted in response to this NOSI.
  • The Research Strategy must not exceed 5 pages and summarize the activities of the parent grant that encompass those proposed in the supplemental request and describe how these activities will augment and/or enhance the understanding of how body composition informs the relationship between chemotherapy dose and adverse events.
  • The Research Strategy must include:
    • The supplement's purpose;
    • The relationship of the supplement request to the parent grant;
    • Description of data collection methods and analytic plans; and
    • The additional value provided to the underlying funded research (parent grant) of the PI and the collaborating investigators.
  • NCI requires applicants to submit electronically through Grants.gov. All applications (including those for multi-project activity codes) must be submitted electronically using a single-project application form package with the Competition ID of “FORMS-E-ADMINSUPP-RESEARCH”
  • The process for Streamlined Submissions using the eRA Commons cannot be used for this initiative.

NOTE: For funding consideration, applicants must include “NOT-CA-20-036” (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.

Administrative Review Process:
NCI will conduct administrative reviews of applications submitted to their IC and will support the most meritorious applications submitted for consideration, based upon the availability of funds.

Criteria:

  1. Is the work proposed within the scope of the active award and will it realistically be completed within one year?
  2. Are the measures of body composition, treatment, and all relevant outcomes accurate and valid?
  3. Does the work in the administrative supplement fill an identified gap in the scientific literature?
  4. Will the work provide information that is clinically relevant and will improve the health of cancer survivors?
  5. Will the proposed work be a valuable data resource that is accessible to a broad scientific community?

Applicants are strongly encouraged to notify the program contact at the Institute supporting the parent award that a request has been submitted in response to this NOSI to facilitate efficient processing of the application.

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

 

Inquiries

Please direct all inquiries to:

Joanne Elena, Ph.D., M.P.H.,
Division of Cancer Control and Population Sciences
National Cancer Institute (NCI)
Telephone: 240-276-6818
Email: joanne.elena@nih.gov

Or

Kelly Filipski, Ph.D., M.P.H.,
Division of Cancer Control and Population Sciences
National Cancer Institute (NCI)
Telephone: 240-276-6841
Email: kelly.filipski@nih.gov