Key Dates

Related Announcements

• October 9, 2020 - Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional). See NOFO PA-20-272.

Issued by

National Cancer Institute (NCI)

Purpose

The Division of Cancer Prevention (DCP) at the National Cancer Institute (NCI) announces this Notice of Special Interest (NOSI) to encourage current grant or cooperative agreement awardees to apply for administrative supplement funds to support research with an overall goal of characterizing the natural history and longitudinal dynamics of lung nodules through harnessing the power of cancer data reuse with the National Lung Screening Trial datasets.  

Background

The primary endpoint for lung cancer screening trials, cancer mortality, requires long and extensive follow-up to ensure trial completion. The inclusion of a surrogate endpoint, such as lung nodule development and progression, can improve the speed and efficiency of clinical trials without affecting the scientific rigor. Therefore, this NOSI supports the characterization of the lung nodules to be used as a surrogate endpoint for clinical trials and for physician support services. Radiologists and artificial intelligence algorithms can identify and track nodules over time. The combination of which may allow for distinguishing between the trajectories of benign and precancerous nodules, particularly when the changes in lung nodules are linked to pathologic diagnoses. The goal of the supplemental funding is to support research to define and improve the identification of benign, pre-cancerous and cancerous lung nodules through longitudinal analysis of nodule characteristics to improve physician support services and precision cancer screening and detection.
Radiologists utilize quantitative imaging biomarkers such as a nodule’s volume, surface area, density, shape, and margins to determine if a nodule should be biopsied or removed. Enhanced capabilities of CT-scanners have improved imaging data, such as decreased scanning thickness and enhanced image resolution. These technological advancements allow radiologists to identify nodules earlier in their development. The improved detection of these smaller nodules increases the difficulty for radiologists to recommend a course of action as knowing the trajectory of these nodules requires more information and a high percentage of the nodules will remain benign. Improved quantitative imaging biomarkers that account for the natural history of the nodule provides more context to the clinicians on a future course of action for biopsy or removal and overall prevention of lung cancer. 

The National Lung Screening Trial (NLST; NCT00047385) was a randomized controlled trial conducted by the Lung Screening Study group and the American College of Radiology Imaging Network to determine whether screening for lung cancer with low-dose helical computed tomography (CT) reduces mortality from lung cancer in high-risk individuals relative to screening with chest radiography. Approximately 54,000 participants were enrolled between August 2002 and April 2004. Data collection has ended, and information is complete through December 31, 2009.

NLST datasets include longitudinal CT and pathology images. The datasets are comprehensive; they include data on participant characteristics, screening exam results, diagnostic procedures, lung cancer, histopathologic diagnosis, and mortality. Images from over 75,000 CT screening exams are available. Longitudinal CT scans include three annual screenings and one post-screening follow-up scan. Over 1,200 pathology images from a subset of NLST lung cancer patients (~500 of over 2,000 patients) may be made available. NLST data can be accessed through multiple NIH sources including the Imaging Data Commons, The Cancer Imaging Archive, and the Cancer Data Access System. 

Research Objectives

The research objective of this supplement notice is to examine the natural history of lung nodules using longitudinal analysis of CT scans and clinically relevant data. 
Investigators should request supplemental support to:

•  Apply lung nodule identification software to longitudinal datasets, including but not limited to, the NLST low-dose CT scan dataset;
• Characterize the natural history and trajectory of lung nodules using quantitative imaging biomarkers, including but not limited to, nodule volume;
• Validate quantitative imaging biomarkers the changes of which differentiate between benign, precancerous, and cancerous nodules.
   

Non-responsive Applications

Applications not responsive to this NOSI include those that:

• Propose work that is included in the original funded plan;
• Propose to expand the scope of the parent grant;
• Propose work that would be unreasonable to be completed, given the time and budget requested;
• Propose wet lab experiments to generate new data even if it is to enhance current or existing datasets;
• Do not propose a project that utilizes the NLST low-dose CT-scan dataset;
• Do not propose to use lung nodule volume and longitudinal measurements.
  
   

Application and Submission Information

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

• PA-20-272 - 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-20-272 must be followed, with the following additions:
   

Eligibility

• Only current awardees with an active award of which NCI is signed on to are eligible to apply.
• Only current awardees of an active R01, R37, R00, P01, P30, U01, UM1, UH3, or U19 are eligible to apply.
• PDs/PIs must hold an active award supported through NIH with sufficient time (minimum 1 year) left to complete the proposed project after the supplement has been awarded within the existing project period. Therefore, to be eligible, the parent award must be able to receive funds in FY24 and be active throughout the one-year project period. The parent award must not be in an extension period (e.g., cost or no-cost extension).
• 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 request.
   

Budget and Period of Support

• The budget should not exceed $100,000 in direct costs for the entire allowable 1-year project period of the application/award.
• The proposed project must be within the scope of the parent award.  
• The administrative supplement application budget is limited to 1 year only.
• Supplements designed to meet cost increases for unanticipated expenses within the original scope of the project will not be considered.
   

Submitting Applications

Application Due Date: Submission must be received by July 8, 2024, by 5:00 PM local time of applicant organization for FY 2024 funding. The NOSI will expire July 9, 2024. 
 

For funding consideration, applicants must include “NOT-CA-24-058" (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.
 

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-24-058”
 

To facilitate efficient processing of the request, applicants are strongly encouraged to notify the assigned NCI Program Official for the parent award that a request has been submitted in response to this NOSI.
 

Page Limits

The application must include the following sections and adhere to the following limits:

• Project Summary/Abstract: 30 lines of text
•  Project Narrative: 3 sentences
• Specific Aims: 1 page
• Research Strategy: 3 pages. 
• Biographical Sketch: for Senior/Key Personnel and Significant Contributors only.

Review and Selection Process

NCI will conduct administrative reviews of applications and will support the most meritorious applications submitted for consideration, based upon availability of funds. Additionally, NCI program staff will evaluate applications using the following selection factors:

• Does the administrative supplement reasonably allow for the proposed project to be completed, given the time and budget requested?
• Are the proposed activities relevant to the parent grant and original work scope?
•  Does the applicant demonstrate satisfactory progress towards achieving the aims of the parent grant, as appropriate to the current stage of the project?
• Does the proposed project for supplemental funding fill an identified gap in the scientific literature that advances cancer prevention?
   

Applicants are encouraged to discuss their application with the scientific/research contacts listed in this NOSI prior to submission.
 

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

Inquiries

Scientific/Research Contact(s)

Amanda Skarlupka, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-7360
Email: Amanda.skarlukpa@nih.gov

Financial/Grants Management Contact(s)

Crystal Wolfrey 
National Cancer Institute (NCI)
Telephone: 301- 496-8634
Email: wolfreyc@mail.nih.gov