This Funding Opportunity Announcement (FOA) is a part of the National Cancer Institute (NCI) initiative intended to support Cancer Prevention Clinical Trials Network (CP-CTNet).
The goals for the CP-CTNet include:
Design and conduct early phase clinical trials to assess the safety, tolerability,
and cancer preventive potential of agents and interventions of varying classes, many of which target molecules or processes known to be important during carcinogenesis.
These trials include phase 0 (microdosing), phase I (dose-finding), and phase II (preliminary efficacy) clinical trials; Characterization of the effects of these agents and interventions on their molecular targets, as well as on other biological events associated with cancer development (such as cell proliferation, apoptosis, growth factor expression, oncogene expression, immune response) and correlation of these effects with clinical endpoints.
Development of further scientific insights into the mechanisms of cancer prevention by the agents examined, including the development of novel potential markers as determinants of response.
CP-CTNet consists of two types of components:
Five CP-CTNet Sites (covered by companion FOA, RFA-CA-18-029); and One CP-CTNet Data Management, Auditing, and Coordinating Center (DMACC, covered via this FOA).
The CP-CTNet Sites will provide scientific leadership in development and conduct of early phase cancer prevention clinical trials as well as manage and analyze the data.
The DMACC will support the CP-CTNet Sites and coordinate trans-Network activities with the following specific responsibilities:
(i) centralized data management and data reporting, (ii) clinical trials auditing, and (iii) administrative and logistical coordination across CP-CTNet.