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Barrett's Esophagus & Gastroesophageal Reflux Disease - NCT00513331-07652(Clinical Trial 179383)



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City:  Paramus
State:  
NJ
Zip Code: 07652
Conditions: Barrett's Esophagus - GERD
Purpose: This is a study of Barrett's Esophagus (BE) and Gastroesophageal Reflux Disease (GERD). It aims to look at the long term efficacy of evidence-based cutting edge diagnostic and therapeutic algorithms and techniques such as radiofrequency ablation, endoscopic mucosal resection and surveillance endoscopy with biopsy. Additionally, biological analyses will be performed in hopes of identifying biomarkers associated with the progression of BE to esophageal cancer.
Study summary: 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.
Criteria: 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.
Study is available at: Valley Health System - The Valley Hospital - Luckow Pavilion
Paramus, NJ 07652
United States

Primary Contact:
Sobeida J. Santana-Joseph, MSN
Email: ssantan@valleyhealth.com
Phone: 201-634-5567

Secondary Contact:
Sobeida J. Santana-Joseph, MSN
Email: ssantan@valleyhealth.com
Phone: 201-634-5567
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 22, 2011
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