Barrett's Esophagus Patient Registry

• Conditions: Barrett Esophagus; Esophageal Adenocarcinoma; Gastroesophageal Reflux

• Registration Number: NCT01776346
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

The ultimate goal of the Barrett's Esophagus Patient Registry is to help develop more effective targeted screening strategies and treatment options for Barrett's esophagus and esophageal adenocarcinoma (EAC). We plan to do by developing a registry that will serve as a platform. Examples of analyses could include identifying genetic determinants and biomarkers that predict BE, progression of BE to EAC, as well as the response to therapies.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Status Verified: 2013-01
• Study First Submitted: 2013-01-22
• Study First Submitted QC: 2013-01-23
• Last Update Submitted: 2013-01-23
• Study First Posted: 2013-01-28
• Last Update Posted: 2013-01-28
• Primary Completion: 2021-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 750

Inclusion Criteria

• Barrett's (BE): Patients who have Barrett's esophagus (all stages: Barrett's metaplasia, low-grade dysplasia, high-grade dysplasia) based upon standard endoscopic and histologic criteria.
• Adenocarcinoma (EAC): Patients who have esophageal adenocarcinoma.
• The control cohort will include patients ages 18 and older with no prior history of BE and EAC. These may include patients who are being seen or have been previously seen at MGH GI Associates for conditions including gastroesophageal reflux disease, peptic esophagitis, eosinophilic esophagitis, esophageal motility disorders such as achalasia and nutcracker esophagus.

Exclusion Criteria

• Inability or unwillingness to provide blood samples.
• History of known bleeding disorders.
• Currently awaiting organ transplantation.
• Having an acute or severe chronic illness such as congestive heart failure or any other condition that would prohibit performing the endoscopy.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression to esophageal adenocarcinoma	5 years (on average although follow-up will continue)

Secondary Outcome Measures

Name	Time	Method
Identify and validate genetic determinants that predict progression of BE to EAC and predict response to BE therapy	5 years on average
Evaluate the natural history of BE with and without treatment based on clinical, functional and economic outcomes of the cases	5 years on average

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States