University of Michigan, School of Medicine: the Great Lakes New England (GLNE) Clinical Epidemiology and Validation Center

Objectives

To continue development and validation of biomarker panels for the early detection and risk assessment of epithelial cancers of the GI tract and to assemble a high quality, prospectively collected, protocol driven, carefully documented biorepository to support EDRN collaborative biomarker discovery and validation research.

Program Description

The Great Lakes New England (GLNE) Clinical Epidemiology and Validation Center of the EDRN consists of a collaboration of the following institutions and their consortium partners: University of Michigan Medical Center- Cancer Center, MD Anderson Cancer Center, Dartmouth Medical School-Norris Cotton Cancer Center, the Dana Farber Cancer Institute, and St. Michael Hospital of Toronto. The GLNE proposes to:

• Develop and implement biomarker validation protocols for three different GI tract sites; colorectal adenocarcinoma, esophageal adenocarcinoma, and hepatocellular carcinoma. For colorectal adenocarcinoma detection, the GLNE proposes development of a stool based panel of genetic biomarkers supplemented by serum based proteomic and mucin derived biomarkers. For low esophagus early detection, the GLNE proposes a panel of serum-based methylation biomarkers coupled with tissue based ploidy, cyclin Dl, and a genetic amplicon panel. For hepatocellular detection, an Associate Member affiliated with the GLNE proposes a validation trial of descarboxyprothrombin supplemented by proteomic profiles and proteomics discovered biomarkers.
• Establish a multi-institutional network that develops detailed standard operating procedures and data elements. Data are managed via a Good Computing Practice compliant, Web-fronted informatics network that includes a sample tracking system and a secure protocol server. The GLNE also provides diverse human populations to validate early detection biomarkers for high priority cancers.