Barrett's Esophagus Patient Registry
BPR
1 other identifier
observational
750
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2011
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 22, 2013
CompletedFirst Posted
Study publicly available on registry
January 28, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedJanuary 28, 2013
January 1, 2013
10.9 years
January 22, 2013
January 23, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Progression to esophageal adenocarcinoma
5 years (on average although follow-up will continue)
Secondary Outcomes (2)
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
Study Arms (2)
Barrett's Esophagus/Esophageal Adenocarcinoma
Patients who have Barrett's esophagus or esophageal adenocarcinoma.
Healthy control
Eligibility Criteria
Patients who have been seen at Massachusetts General Hospital.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Biospecimen
Serum (from whole blood), plasma (from whole blood), tissue
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Target Duration
- 5 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator; MD, MPH
Study Record Dates
First Submitted
January 22, 2013
First Posted
January 28, 2013
Study Start
January 1, 2011
Primary Completion
December 1, 2021
Study Completion
December 1, 2021
Last Updated
January 28, 2013
Record last verified: 2013-01