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Barrett's Esophagus Patient Registry (BPR)

This study is currently recruiting participants.
Verified January 2013 by Chin Hur, Massachusetts General Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT01776346
First Posted: January 28, 2013
Last Update Posted: January 28, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Chin Hur, Massachusetts General Hospital
  Purpose
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.

Condition
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)
Groups/Cohorts
Barrett's Esophagus/Esophageal Adenocarcinoma
Patients who have Barrett's esophagus or esophageal adenocarcinoma.
Healthy control

  Eligibility

Information from the National Library of Medicine

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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.
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01776346


Contacts
Contact: Katherine Perzan, BA 617-726-1431 kperzan@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Katherine Perzan, BA    617-726-1431    kperzan@partners.org   
Sponsors and Collaborators
Massachusetts General Hospital
  More Information

Responsible Party: Chin Hur, Principal Investigator; MD, MPH, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01776346     History of Changes
Other Study ID Numbers: 2010P002224
First Submitted: January 22, 2013
First Posted: January 28, 2013
Last Update Posted: January 28, 2013
Last Verified: January 2013

Additional relevant MeSH terms:
Barrett Esophagus
Adenocarcinoma
Gastroesophageal Reflux
Esophageal Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
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