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The Good,The Bad and The Ugly for Clinical Markers: Possibilities For the Future

By Kim Jessup

National Cancer Institute

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Abstract

Markers are becoming more important in NCI-supported clinical trials.  These trials are becoming increasingly oriented toward precision medicine. This presentation provides an overview of a database for markers used in NCI Trials as well as definitions of markers and their uses in trials.  It also includes a brief overview of general aspects of validation of assays and their markers.

Bio

J. Milburn 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 Basic Research Laboratory in the NCI Center for Cancer Research. His research targets a novel embryonic retrogene that drives cancer stem cells in metastatic human colorectal carcinoma.

Cite this work

Researchers should cite this work as follows:

  • Kim Jessup (2015), "The Good,The Bad and The Ugly for Clinical Markers: Possibilities For the Future," https://ncihub.cancer.gov/resources/1029.

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