Barrett's Esophagus Patient Registry (BPR)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Massachusetts General Hospital
Sponsor:
Information provided by (Responsible Party):
Chin Hur, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01776346
First received: January 22, 2013
Last updated: January 23, 2013
Last verified: January 2013
  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 Massachusetts General Hospital:

Primary Outcome Measures:
  • Progression to esophageal adenocarcinoma [ Time Frame: 5 years (on average although follow-up will continue) ] [ Designated as safety issue: No ]

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 ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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

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

No publications provided

Responsible Party: Chin Hur, Principal Investigator; MD, MPH, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01776346     History of Changes
Other Study ID Numbers: 2010P002224
Study First Received: January 22, 2013
Last Updated: January 23, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Adenocarcinoma
Barrett Esophagus
Gastroesophageal Reflux
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Abnormalities
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Esophageal Motility Disorders
Deglutition Disorders

ClinicalTrials.gov processed this record on July 20, 2014