Project Funding Details


Title
CORE INFRASTRUCTURE SUPPORT FOR THE CANCER PREVENTION AGENT DEVELOPMENT PROGRAM
Alt. Award Code
261201200042I-P00005-759101900129-1
Funding Organization
National Cancer Institute
Budget Dates
2022-10-01 to 2023-09-30
Principal Investigator
Limburg, Paul
Institution
Mayo Clinic
Region
North America
Location
Rochester, MN, US

Collaborators

View People Map
This project funding has either no collaborators or the information is not available.

Technical Abstract

The National Cancer Institute (NCI), Division of Cancer Prevention (DCP) Phase 0/I/II Cancer Prevention Clinical Trials Program supports early clinical trials to rapidly evaluate the clinical activity and biologic effects of cancer preventive agents of interest to DCP. The agents to be studied shall include agents developed by the pharmaceutical industry and provided to DCP for collaborative development, commercially available agents, and agents developed by DCP. The objectives of this Task Order are to provide the core infrastructure to support the conduct of the clinical trials. The Contractor shall conduct early clinical trials (Phase 0, I, and II) of DCP-sponsored agents, evaluate biologic effects of these agents on their molecular targets, evaluate other relevant biologic effects, and determine clinically relevant outcomes/correlates. This Task Order calls for the maintenance of the administrative core infrastructure to support the clinical and laboratory activities. These activities include but are not limited to: a. Maintaining the infrastructure to conduct and complete Early Phase Chemoprevention Clinical Trials. b) Revising the Data and Safety Monitoring Plan and Multi-Institutional Monitoring Plan plans as required for DCP approval, following guidelines established in the DCP approved plans, in order to support the conduct of NCI clinical trials. See http://prevention.cancer.gov/clinicaltrials/management/consortia. c) Serving as the liaison between DCP, NCI and sub-contractors performing individual clinical trials. d) Monitoring the performance of individual studies both remotely and via on-site monitoring visits. e) Providing data management to support trial conduct. f) Participating in annual meetings - i.e. Scientific and I-SCORE Individual clinical trials shall be funded under separate Task Orders.

Cancer Types

  • Not Site-Specific Cancer

Common Scientific Outline (CSO) Research Areas

  • 3.3 Prevention Chemoprevention
  • 3.6 Prevention Resources and Infrastructure Related to Prevention