Cancer Prevention Clinical Trials Network (CP-CTNet): CP-CTNet Sites (UG1 Clinical Trial Required)

Background
The National Cancer Institute (NCI) is issuing this Notice of Funding Opportunity (NOFO) to support the Cancer Prevention Clinical Trials Network (CP-CTNet). This initiative aims to provide infrastructure for early-phase cancer prevention clinical trials. The goal is to evaluate biologic effects of interventions and determine clinically relevant correlates to advance their development for cancer prevention. The CP-CTNet will focus on multiple cancer prevention clinical trials targeting various organ sites, utilizing UG1 cooperative agreement funding mechanisms.

Grant Details
The CP-CTNet Sites will be responsible for the design, conduct, and reporting of early phase clinical trials (phase 0-II) that assess the safety, tolerability, and cancer preventive potential of various agents and interventions. Specific tasks include:
1. Designing and conducting early phase clinical trials targeting relevant pathways in carcinogenesis.
2. Characterizing biological effects of agents on molecular targets and correlating these with clinical endpoints.
3. Developing insights into mechanisms of cancer prevention and identifying novel response markers.
4. Managing study operations, including quality assurance and compliance with regulations.
5. Conducting a minimum of 1-3 new clinical trials per year with participant accrual targets ranging from 10-40 participants annually depending on site status.
6. Engaging in cross-network trials to facilitate collaborative research efforts.

Eligibility Requirements
Eligible organizations include higher education institutions (public or private), nonprofits, federal agencies, U.S. territories, and foreign organizations are not eligible to apply. Institutions are encouraged to include diverse applicants from underrepresented groups in their proposals.

Period of Performance
The project period will span six years, beginning in FY 2025.

Grant Value
NCI intends to commit $8,750,000 each year for six years, supporting approximately five awards for CP-CTNet Sites. Each award may request up to $1,375,000 in direct costs annually.

Place of Performance
The specific geographic locations for the performance of the grant have not been detailed but will involve multiple institutions collaborating within the CP-CTNet framework.