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

Stopped early · Phase 3

Conditions studied: Esophageal Metaplasia

In brief

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.

Key facts

Study ID

NCT00161200

Run by

University of Medicine and Dentistry of New Jersey

People needed

60

Starts

2002-12-01

Expected to finish

2006-10-01

Last updated by the study team

2009-12-11

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Dyspeptic symptoms, upper abdominal pain, heartburn, regurgitation;
• Endoscopically - normal appearing GE junction, irregular z-line, or erosive esophagitis up to Grade 2.

You may not qualify if…

• Barrett's esophagus (Endoscopically greater than 2 cm of columnar epithelium on endoscopy and the presence of specialized columnar epithelium on histology);
• Patients who have been taking a PPI longer than the 3 months proceeding study entry. Patients currently taking a PPI but for less than 3 months who are not willing to discontinue PPI treatment for 4 weeks prior to enrollment into this study.
• Severe esophagitis Grade 3 or 4
• Documented active duodenal or gastric ulcer (at least 0.5cm diameter). Patients with erosions can be included.
• Presence of esophageal varices
• History of gastric surgery altering normal anatomy (eg, Billroth procedure, gastric bypass)
• Pregnant or nursing patients

Where it is running

• Cancer Institute of New Jersey — New Brunswick, New Jersey, United States

Full record on ClinicalTrials.gov

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