Notice of Intent to Publish a Funding Opportunity Announcement for NCI Cancer Screening Research Network: Statistics and Data Management Center (UG1 Clinical Trial Required)
Notice Number:
NOT-CA-22-130

Key Dates

Release Date:
September 28, 2022
Estimated Publication Date of Funding Opportunity Announcement:
November 11, 2022
First Estimated Application Due Date:
February 06, 2023
Earliest Estimated Award Date:
December 01, 2023
Earliest Estimated Start Date:
December 01, 2023
Related Announcements

NOT-CA-22-129 - Notice of Intent to Publish a Funding Opportunity Announcement for NCI Cancer Screening Research Network: ACCrual, Enrollment, and Screening Sites (ACCESS) Hub (UG1 Clinical Trial Required)

NOT-CA-22-131 - Notice of Intent to Publish a Funding Opportunity Announcement for NCI Cancer Screening Research Network: Coordinating and Communication Center (UG1 Clinical Trial Required)

Issued by

National Cancer Institute (NCI)

Purpose

The National Cancer Institute (NCI) intends to promote a new initiative by publishing a Funding Opportunity Announcement (FOA) to establish a new network entitled the Cancer Screening Research Network (CSRN) to conduct trials and studies specifically related to cancer screening. To support this initiative, the NCI intends to publish three Funding Opportunity Announcements (FOA) soliciting applications for UG1 cooperative research agreements to include Accrual, Enrollment, and Screening Site (ACCESS) Hubs, a Statistics and Data Management Center (SDMC), and a Coordinating and Communication Center (CCC). These entities will work collaboratively on CSRN trials and studies.

The primary goal of the CSRN is the conduct of multi-center cancer screening trials and studies. This network is designed to take advantage of large and diverse populations receiving routine care in a variety of healthcare settings. The CSRN will engage populations in rigorous studies focused on cancer screening to improve early cancer detection and evaluate emerging cancer-screening modalities and strategies, with the ultimate goal of reducing cancer incidence, and cancer-related morbidity and mortality.
Within the new screening network, the SDMC will provide statistical leadership to ensure effective design, conduct, and analysis of CSRN trials and studies. In addition, it will provide centralized data management expertise, quality control, and reporting in support of cancer screening studies.
The purpose of this Notice is to allow potential applicants sufficient time to develop meaningful collaborations among multi-disciplinary investigators with expertise in cancer screening and provide ample opportunity for organizations to develop responsive applications.

The FOA is expected to be published in fall 2022 with an expected application due date in spring 2023.
This FOA will utilize the UG1 activity code. Details of the planned FOA are provided below.

Research Initiative Details

This Notice encourages investigators with expertise and insights into the area of cancer screening or other disease screening to begin to consider applying for these new FOAs. In addition, collaborative investigations combining expertise in other disease screening will be encouraged and these investigators should also consider applying for these FOAs.

Cancer screening provides a unique opportunity to diagnose cancers and pre-cancerous lesions before symptoms develop, with the intent of identifying cancer in an early stage when intervention can improve patient outcomes. The NCI Cancer Screening Research Network (CSRN) will provide an infrastructure to efficiently conduct cancer screening clinical trials to assess the clinical utility of innovative cancer screening modalities and strategies. This network will use NCI’s clinical trial infrastructure, and prior experience with Medidata Rave is required. New emerging technologies, including Multi-Cancer Detection (MCD) assays that evaluate cell-free DNA or other biological components, are rapidly coming forward for commercial availability. One interest of the CSRN is the systematic evaluation of the MCD assays as cancer screening tools. A variety of challenges exist in the design and conduct of randomized controlled trials that evaluate MCD tests to screen for multiple different cancers. As an initial effort, the CSRN will collaboratively develop a feasibility study, referred to as the Vanguard study, to inform the future design of a platform trial to evaluate multiple different technologies for cancer screening in a flexible, but rigorous manner. This effort will pave the way for future large-scale clinical trials and other studies to comprehensively assess a variety of cancer screening modalities. Please access the CSRN website at https://prevention.cancer.gov/CSRN for more information.

Anticipated Research Strategy subheadings include:

SDMC Organizational Structure and Statistical Leadership in Clinical Trials - Describe the organizational structure and leadership of the SDMC as well as the qualifications of key personnel in the SDMC.

SDMC Approach for CSRN and Statistical Experience with Multi-Center Clinical Trials - Describe the statistical approach to trial design and analysis plans for multi-institutional clinical trials, including guidelines for interim monitoring and general procedures for sample size estimation and randomization. Describe the process for data management and insurance of quality control and security. Provide prior examples of execution of these tasks in a large clinical trial.

SDMC Approach to the Large Clinical Trial Using the Vanguard (Pilot) Study - The initial role of the CSRN will be to perform a pilot study called the Vanguard study that assesses the feasibility of initiating a randomized control trial (RTC) of multi-cancer detection (MCD) assays. Elements of the Vanguard study design will be included in the funding announcement. Describe the approach to a large clinical trial from a statistical and data management perspective that would build on the results of the described Vanguard study.

Funding Information
Estimated Total Funding

NCI intends to commit $1M in FY 2024

Expected Number of Awards

1

Estimated Award Ceiling

TBD

Primary Assistance Listing Number(s)

93.393; 93.394; 93.399

Anticipated Eligible Organizations
Public/State Controlled Institution of Higher Education
Private Institution of Higher Education
Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education)
Small Business
For-Profit Organization (Other than Small Business)
State Government
Indian/Native American Tribal Government (Federally Recognized)
County governments
Independent school districts
Public housing authorities/Indian housing authorities
U.S. Territory or Possession
Indian/Native American Tribal Government (Other than Federally Recognized)
Regional Organization
Eligible Agencies of the Federal Government

Applications are not being solicited at this time. 

Inquiries

Please direct all inquiries to:

Paul Pinsky, Ph.D.

National Cancer Institute (NCI)

240-276-7014

Email: CSRN@nih.gov

Elyse LeeVan, M.D.
National Cancer Institute (NCI)
Telephone: 240-276-7314
Email: CSRN@nih.gov