2012 DCP Consortia for Early Phase Prevention Trials
The Division of Cancer Prevention conducts systematic early clinical development of promising preventive agents through its Phase 0/I/II Cancer Prevention Clinical Trials Program, also known as the Consortia for Early Phase Prevention Trials (view on cancer.gov). Cancer prevention drug discovery is identifying many new agents, including an increasing number of agents that intervene in specific molecular pathways thought to be critical to cancer development. Since cancer prevention studies focus on high-risk populations that do not necessarily harbor a detectable cancer, these studies require extensive biomarker analysis, investigation of the biologic effects of the cancer preventive agents on their intended molecular targets, and correlation with clinically relevant endpoints.
The data from several of these Early Phase Prevention Trials studies are available for request on CDAS. You may click the button below to browse these studies:
The goals are:
- To efficiently design and conduct early phase clinical trials necessary to assess the potential of cancer preventive agents of various classes, many of which are directed at molecular targets which have been shown to be expressed in intraepithelial neoplasia (IEN).
- To characterize the biological effects of new cancer preventive agents on their defined molecular targets as well as on multiple endpoints associated with carcinogenesis, such as proliferation, apoptosis, growth factor expression, oncogene expression, and others. Correlation of these effects with clinically relevant endpoints is required.
- To develop further scientific insights into the mechanisms of cancer prevention by the agents examined and to continue to develop novel potential markers as determinants of response.
The de-identified data collected in each trial is available for other research. For each trial the data is presented in two formats:
- Primary - A large analytic dataset with one record for each trial participant and containing sufficient information to replicate the trial outcomes. An adverse event dataset with one record per adverse event.
- Secondary - The data in the original format as collected. This is often a dataset for each source of information, and will need to be pieced together.