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Barrett's Esophagus Patient Registry (BPR)

This study is currently recruiting participants.
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Verified January 2013 by Chin Hur, Massachusetts General Hospital
Information provided by (Responsible Party):
Chin Hur, Massachusetts General Hospital Identifier:
First received: January 22, 2013
Last updated: January 23, 2013
Last verified: January 2013
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.

Barrett Esophagus Esophageal Adenocarcinoma Gastroesophageal Reflux

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Barrett's Esophagus Patient Registry

Resource links provided by NLM:

Further study details as provided by Chin Hur, Massachusetts General Hospital:

Primary Outcome Measures:
  • Progression to esophageal adenocarcinoma [ Time Frame: 5 years (on average although follow-up will continue) ]

Secondary Outcome Measures:
  • Identify and validate genetic determinants that predict progression of BE to EAC and predict response to BE therapy [ Time Frame: 5 years on average ]
  • Evaluate the natural history of BE with and without treatment based on clinical, functional and economic outcomes of the cases [ Time Frame: 5 years on average ]

Biospecimen Retention:   Samples With DNA
Serum (from whole blood), plasma (from whole blood), tissue

Estimated Enrollment: 750
Study Start Date: January 2011
Estimated Study Completion Date: December 2021
Estimated Primary Completion Date: December 2021 (Final data collection date for primary outcome measure)
Barrett's Esophagus/Esophageal Adenocarcinoma
Patients who have Barrett's esophagus or esophageal adenocarcinoma.
Healthy control


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients who have been seen at Massachusetts General Hospital.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01776346

Contact: Katherine Perzan, BA 617-726-1431

United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Katherine Perzan, BA    617-726-1431   
Sponsors and Collaborators
Massachusetts General Hospital
  More Information

Responsible Party: Chin Hur, Principal Investigator; MD, MPH, Massachusetts General Hospital Identifier: NCT01776346     History of Changes
Other Study ID Numbers: 2010P002224
Study First Received: January 22, 2013
Last Updated: January 23, 2013

Additional relevant MeSH terms:
Barrett Esophagus
Gastroesophageal Reflux
Esophageal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Digestive System Abnormalities
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms processed this record on August 23, 2017