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Esophageal Metaplasia Using a Novel Antibody: Reversibility by Proton Pump Inhibitor

NCT00161200 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2009-12-11

No results posted yet for this study

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.

Conditions

  • Esophageal Metaplasia

Interventions

DRUG

Ranitidine & Pantoprazole

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • University of Medicine and Dentistry of New Jersey

    lead OTHER

Principal Investigators

  • Kiron Das, MD, PhD · Rutgers, The State University of New Jersey

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-12-31
Primary Completion
2006-10-31
Completion
2006-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00161200 on ClinicalTrials.gov