Esophageal Metaplasia Using a Novel Antibody: Reversibility by Proton Pump Inhibitor
Status:
Terminated
Trial end date:
2006-10-01
Target enrollment:
Participant gender:
Summary
In this project, we are trying to identify patients with the earliest signs of abnormality in
the lining of the lower part of the food pipe (or esophagus) known as intestinal metaplasia
(IM); also commonly called Barrett's esophagus or Barrett's Epithelium (BE). IM is sometimes
difficult to diagnose by routine microscopic examination (called histology). We have
developed a specific antibody, a protein called immunoglobulin that specifically reacts with
another partner protein, if it exists. Using this marker antibody (called mAb Das-1) that has
been patented (US patent #5,888,743), we have shown that this marker can detect the abnormal
changes in the distal esophagus before it is evident by histology. IM usually develops in the
face of long-term acid reflux from the stomach to the esophagus and causes the lining to
change from the normal squamous type (like that of skin) to a type of lining normally seen in
the small intestine and colon. A subgroup of patients with IM may, subsequently, develop
histologically evident Barrett's Epithelium and a small percent of these patients may develop
cancer of the esophagus. Thus, BE is considered as a pre-cancerous condition. We already have
an ongoing IRB for the portion of the project involving taking biopsies and performing the
antibody staining to identify patients that react with the antibody but histologically
negative for BE.
Phase:
Phase 3
Details
Lead Sponsor:
University of Medicine and Dentistry of New Jersey