Barrett's Esophagus Patient Registry (BPR)
Verified January 2013 by Massachusetts General Hospital
Information provided by (Responsible Party):
Chin Hur, Massachusetts General Hospital
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.
||Observational Model: Case Control
Time Perspective: Prospective
|Target Follow-Up Duration:
||Barrett's Esophagus Patient Registry
Primary Outcome Measures:
- Progression to esophageal adenocarcinoma [ Time Frame: 5 years (on average although follow-up will continue) ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
Serum (from whole blood), plasma (from whole blood), tissue
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| 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.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Patients who have been seen at Massachusetts General Hospital.
- 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.
- 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.
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 ClinicalTrials.gov identifier: NCT01776346
|Massachusetts General Hospital
|Boston, Massachusetts, United States, 02114 |
|Contact: Katherine Perzan, BA 617-726-1431 email@example.com |
Massachusetts General Hospital
No publications provided
||Chin Hur, Principal Investigator; MD, MPH, Massachusetts General Hospital
History of Changes
|Other Study ID Numbers:
|Study First Received:
||January 22, 2013
||January 23, 2013
||United States: Institutional Review Board
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on November 27, 2014
Digestive System Abnormalities
Digestive System Diseases
Digestive System Neoplasms
Esophageal Motility Disorders
Head and Neck Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial