Skip to content. | Skip to navigation

National Cancer Institute U.S. National Institutes of Health www.cancer.gov

Navigation

Personal tools

You are here: Home / Protocols / GLNE 003: Preliminary Validation of Biomarkers Predictive of Barrett’s Esophagus Progression to Dysplasia and Adenocarcinoma

GLNE 003: Preliminary Validation of Biomarkers Predictive of Barrett’s Esophagus Progression to Dysplasia and Adenocarcinoma

107
Brenner, DeanUniversity of Michigan

No coordinating investigator defined.

No involved investigator sites defined.

FISH
Glycomics
Proteomics
Hypermethylation
Metabolomics
G.I. and Other Associated Cancers Research Group

   Recognizing that novel potential biomarkers are continually being identified and will need to be validated in a rapid, efficient, and scientifically rigorous manner, the NCI has made an enormous commitment to the development of a network that will facilitate biomarker development and validation in multiple organ sites. As part of the National Cancer Institute-funded Early Detection Research Network (EDRN), the Great Lakes-New England Clinical Epidemiological Center (GLNE CEC) proposes a research program that provides the structure for validating and discovering potential surrogate endpoint biomarkers (“biomarkers”). Although examples of such biomarkers are currently in clinical use (i.e. CEA, CA-125), there are limitations to all of them. Our consortium focuses specifically on gastrointestinal neoplasia.    There are three goals for this phase of the proposed research. 1. Establish the feasibility of measuring the biomarkers in a multi-center clinical trial. 2. Estimate the variance of the biomarkers in cohorts defined by sex, race, age and histologic diagnosis (non-Barrett’s controls, Barrett’s intestinal metaplasia, Barrett’s intestinal dysplasia [low and high-grade] and adenocarcinoma). 3. Determine if the distributions of the biomarkers differ significantly among patients with different histologic diagnoses.    In this protocol, biological samples will consist of serum, plasma, urine, and biopsies from Barrett’s esophagus (metaplasia, low and high-grade dysplasia) patients, from patients with esophageal adenocarcinoma, and from non-Barrett’s controls. Samples will be assayed for villin, p53, Hsp27, cyclooxygenase-2, and Cyclin D1. Samples will also be used for two biomarker discovery projects, one exploring genetic expression using genomic microarrays and a second using two-dimensional gene arrays to discover and characterize amplified proteins associated with esophageal carcinogenesis. Fifty subjects will

Establish the feasibility of measuring the biomarkers in a multi-center clinical trial. 1.2   Estimate the variance of the biomarkers in cohorts defined by sex, race, age and histologic diagnosis (Barrett's intestinal metaplasia, Barrett's intestinal dysplasia [low-grade or high-grade], Adenocarcinoma, and non-Barrett’s controls). 1.3   Determine if the distributions of the biomarkers differ significantly among patients with different histologic diagnoses.

There are currently no biomarkers annotated for this protocol.

No datasets are currently associated with this protocol.


2015 EDRN PI Orientation

The New and Continuing EDRN Principal Investigator Orientation will take place October 15–16, 2015 in Bethesda, Maryland.

Announcement 06/30/2015

A funding opportunity for a new pancreatic cancer initiative, called The Pancreatic Cancer Detection Consortium (U01), has been released. For more information, please go to http://grants.nih.gov /grants/guide/ pa-files/ PAR-15-289.html.

Announcement 04/08/2015

Thank you to everyone who made the 29th EDRN Steering Committee Meeting a success. The orientation for new and continuing EDRN PIs will be held October 15-16, 2015 on the NCI campus. More information will be available later this summer.