Barrett's Esophagus & Gastroesophageal Reflux Disease

Barrett's esophagus (BE) is a known premalignant condition of the esophagus, predisposing to
the development of esophageal adenocarcinoma. BE represents a change in the lining (mucosa)
of the esophagus which is known to be produced as a result of chronic gastroesophageal
reflux. The current standard of care for patients with BE includes serial performance of
upper endoscopy with multiple biopsies, performed at designated time intervals. However,
the emergence of new technologies for the management of this condition has made the care of
these patients non-uniform, and subject to biases of individual treating physicians.

The protocol at The Valley Hospital and Blumenthal Cancer Center aims to standardize the
management of patients with Barrett's esophagus, with and without dysplasia, using
evidence-based, cutting edge diagnostic and therapeutic algorithms and techniques such as
radiofrequency ablation, endoscopic mucosal resection, and surveillance endoscopy with
biopsies. If biopsies suggest the development of carcinoma or high grade dysplasia surgical
removal of the esophagus is recommended. This study aims to look at the long-term efficacy
of these procedures. In addition, data regarding clinical outcomes will be collected as well
as blood, tissue and surgical specimens for proteomic analysis in hopes of identifying
biomarkers associated with the progression of dysplasia to adenocarcinoma. Although
patients will ultimately make their own informed decisions regarding the management of their
BE, this protocol serves to unify physician recommendations, and allows for the collection
and interpretation of data.

Inclusion Criteria:

- Male or female, age 18 to 85.

- Patient must have Barrett's Esophagus. Patients may be enrolled based on previous
endoscopy reports and/or pathology reports. It is not necessary that each patient
have endoscopy for the sole purpose of enrollment.

- Must agree to allow their clinical information to be collected, stored, analyzed and
reported.

- Must allow portions of their biopsy/surgical specimens to be collected, stored,
analyzed and reported.

- Must agree to fill out patient questionnaires in conjunction with the research study
assistant assigned to this protocol (either in person or via telephone contact) at
designated timepoints.

Exclusion Criteria:

- Intestinal metaplasia of the cardia, without an esophageal columnar lining.

- Unable to provide informed consent.

- Unable or unwilling to undergo endoscopic procedures.