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Markers are becoming more important in NCI-supported clinical trials. These trials are becoming increasingly oriented toward precision medicine. Unfortunately, Program Staff do not have access to a database that tracks such markers to make sure their use can be managed. The Center for Coordinating Clinical Trials (CCCT) was mandated to create the Clinical Trials Reporting Project (CTRP) to coordinate tracking all elements of the clinical trials. CTRP now contains nearly 7,000 trials with roughly half of them including markers on all patients; 12% of said trials have integral markers that are essential for performance of the trial, e.g., mutations for eligibility for targeted therapies. The presentation will cover the CTRP Marker database and its potential as a resource for staff and potentially the public. |
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Kim Jessup, M.D. is a surgical oncologist who joined the Cancer Diagnosis Program at NCI as Chief of the Diagnostics Evaluation Branch in 2006. This branch facilitates the transition of discovery-based markers into in-vitro diagnostics that are used in clinical trials. As part of this effort, Dr. Jessup helped with the creation of the Markers Database in the Clinical Trials Reporting Project as well as the creation of electronic case-report forms (eCRFs) for pharmacodynamic assays for the Experimental Therapeutics-Clinical Trials Network. He also collaborates with the FDA to standardize assays for clinical trials and assists investigators in navigating the requirements for Investigational Device Exemption. In 25 years of practice, he has focused on the multidisciplinary treatment of GI and breast cancer, melanoma, and soft tissue/skeletal sarcomas in several different academic settings. In addition, he led a research effort studying the mechanisms that underpin hepatic metastasis by human colorectal carcinoma and identified two distinct roles for the marker carcinoembryonic antigen in modulating inflammatory responses and promoting metastasis. Currently, Dr. Jessup is a Principal Investigator in the Laboratory of Experimental Carcinogenesis in the NCI Center for Cancer Research. His research targets a novel embryonic retrogene that drives cancer stem cells in metastatic human colorectal carcinoma.
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