NOT-CA-22-130 - Notice of Intent to Publish a Funding Opportunity Announcement for NCI Cancer Screening Research Network: Statistics and Data Management Center (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)
National Cancer Institute (NCI)
The National Cancer Institute (NCI) intends to promote a new initiative to establish a 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 (FOAs) 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, ACCESS Hubs will serve as organizations or groups of organizations that will recruit participants to CSRN trials and studies, and participate in the scientific development and implementation of those trials and studies. ACCESS Hubs will establish multidisciplinary teams of investigators with expertise in disease screening. These individuals will lead efforts within the ACCESS Hub and are encouraged to serve in network leadership positions. ACCESS Hubs will be responsible for the recruitment of participants that reflect the full diversity of their communities, with an emphasis on populations underrepresented in cancer research. In addition to participant accrual, the ACCESS Hub will be responsible for providing cancer screening, performing confirmatory diagnostic workups, and ensuring high-quality data collection at all affiliate organizations.
This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects.
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.
This Notice encourages investigators with expertise and insights in cancer screening or other disease screening to begin to consider applying for these new 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. 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:
Organization and Structure - Describe the organizational structure of the ACCESS Hub (for example hospitals, individual clinics, referral sites, etc.) including affiliate organizations. Describe the catchment area for these entities.
Leadership and Personnel Structure - Given the scope of screening clinical trials and the necessity of diverse expertise, the ACCESS Hub will require a multi-disciplinary leadership team. Please provide the PI(s) qualifications and describe how the PI and other leaders collaborate, coordinate, and oversee the research effort for the CSRN.
Experience with Disease Screening and Prevention Trials - Provide the highlights of the multi-disciplinary team’s accomplishments relative to implementing disease screening clinical trials and other human subjects research in the group’s practice settings during the past 5 years.
Approach to 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. This study would inform the design of a future RTC to assess the clinical utility of MCD assays for cancer screening. In this subsection, explain how the proposed ACCESS Hub would aid in the coordination, development, and implementation of the Vanguard study.
Oversight of the Research Efforts - The ACCESS Hub must have the capacity to perform data management and oversight for CSRN research activities for the Hub and its affiliate organizations. Describe the procedures and flow of data collection and quality control. Describe how the ACCESS Hub will ensure compliance with regulatory requirements.
NCI intends to commit $8M in FY 2024
93.393; 93.394; 93.399
Applications are not being solicited at this time.
Please direct all inquiries to:
Paul Pinsky, Ph.D.
National Cancer Institute (NCI)
Elyse LeeVan, M.D.
National Cancer Institute (NCI)