Internal Deadline: Contact ORIF.
LOI: January 28, 2023
External Deadline: February 28, 2023, 5pm PT
Award Type: Cooperative Agreement
Estimated Number of Awards: 10 – 15
Anticipated Award Amount: $8M
Who May Serve as PI: Standard NIH requirements.
Process for Limited Submissions
PIs must submit their application as a Limited Submission through the Office of Research Application Portal: https://rii.usc.edu/oor-portal/.
Materials to submit include:
- (1) Single Page Proposal Summary (0.5” margins; single-spaced; font type: Arial, Helvetica, or Georgia typeface; font size: 11 pt). Page limit includes references and illustrations. Pages that exceed the 1-page limit will be excluded from review.
- (2) CV – (5 pages maximum)
Note: The portal requires information about the PIs and Co-PIs in addition to department and contact information, including the 10-digit USC ID#, Gender, and Ethnicity. Please have this material prepared before beginning this application.
Overall Goals of CSRN: The overall goal of the CSRN is to evaluate technologies and strategies for the purpose of cancer screening in asymptomatic individuals.
To successfully achieve this goal, the CSRN must:
- Establish the organizational and administrative infrastructure of all necessary components needed to implement cancer screening clinical studies and trials, especially a large, randomized control trial for cancer screening.
- Develop cancer screening trials to evaluate emerging cancer detection modalities for clinical utility.
- Assess the clinical utility of cancer screening programs or biomarkers of detection including downstream interventions and health outcomes.
- Apply precision medicine approaches to screening using novel risk assessment tools to individualize screening protocols.
- Evaluate the effectiveness, feasibility, and scalability of screening strategies in real-world settings.
- Identify and address technical, process, and/or cultural challenges to adapt the implementation of screening strategies for diverse practice settings.
- Conduct surveillance of cancer screening in diverse populations to track progress and characterize reach and health outcomes across populations.
- Develop cancer screening studies to evaluate clinical workflow and coordination of care.
This Network will conduct clinical trials and other types of research studies to address the clinical utility, effectiveness, implementation, and other questions related to a wide variety of established and emerging screening methods, technologies, and strategies.
Scope of this FOA: The scope of research conducted by the CSRN will include the evaluation of technologies for early detection of cancer, but not for the purpose of detection of recurrence of a previously treated cancer.
To support the CSRN goal, ACCESS Hubs will be expected to possess the capacity to contribute the following:
- A multidisciplinary team of investigators that, together, have expertise in cancer screening and/or other disease screening with a history of successful recruitment and retention of participants to cancer screening and prevention trials or other disease screening trials or studies with the demonstrated collection of high-quality data for those trials or studies.
- Investigators who will participate in the scientific development of the trials and studies. The principal investigators will participate in the CSRN Steering Committee and other investigators may participate in a variety of working groups or committees.
- Research staff who will be responsible for entering and ensuring quality control of data from enrollment through study completion including long-term follow-up.
- Research staff who will ensure regulatory compliance, participant protection requirements, and compliance with the CCC and SDMC’s policies for auditing, training, and quality assurance.
- Institutions that will be responsible for recruiting, consenting, and registering participants from diverse populations for cancer screening trials and studies.
- Institutions that will be responsible for performing cancer screening and any diagnostic workup as prescribed by a CSRN-approved protocol or for clinical follow-up.
- Institutions that will be responsible for research oversight and data monitoring at each of their affiliate organizations.
- Institutions that will work collaboratively with the CCC and the SDMC. They will ensure trial and study data is securely transferred to the SDMC. ACCESS Hubs will coordinate with the CCC and the SDMC on efforts for long-term data collection through linkages with existing state registries and other entities, such as the virtual pooled registry and the National Death Index.
- Institutions that will be responsible for specimen collection and will also work with the CCC to coordinate the processing and shipping of all biological samples collected from trial participants to be stored at Frederick National Laboratory for future research, as well as coordinating with the CCC as needed to facilitate the shipment of specimens for protocol testing.
- A large potential participant population including individuals who are not living with cancer and who are representative demographically of the greater community.
Visit our Institutionally Limited Submission webpage for more updates and other announcements.