Barrett's Esophagus Patient Registry (BPR)

January 23, 2013 updated by: Chin Hur, Massachusetts General Hospital
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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

750

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who have been seen at Massachusetts General Hospital.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Healthy control
Barrett's Esophagus/Esophageal Adenocarcinoma
Patients who have Barrett's esophagus or esophageal adenocarcinoma.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression to esophageal adenocarcinoma
Time Frame: 5 years (on average although follow-up will continue)
5 years (on average although follow-up will continue)

Secondary Outcome Measures

Outcome Measure
Time Frame
Identify and validate genetic determinants that predict progression of BE to EAC and predict response to BE therapy
Time Frame: 5 years on average
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
5 years on average

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

January 22, 2013

First Submitted That Met QC Criteria

January 23, 2013

First Posted (Estimate)

January 28, 2013

Study Record Updates

Last Update Posted (Estimate)

January 28, 2013

Last Update Submitted That Met QC Criteria

January 23, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010P002224

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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