Barrett's Esophagus Patient Registry

Gastroesophageal Reflux Clinical Trial

— BPR  

Official title:

Barrett's Esophagus Patient Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01776346
• Other study ID #: 2010P002224
• Status: Recruiting
• Phase: N/A
• First received: January 22, 2013
• Last updated: January 23, 2013
• Start date: January 2011
• Est. completion date: December 2021

Study information

• Verified date: January 2013
• Source: Massachusetts General Hospital
• Contact: Katherine Perzan, BA
• Phone: 617-726-1431
• Email: kperzan[@]partners.org
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 750
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Adenocarcinoma
• Barrett Esophagus
• Esophageal Adenocarcinoma
• Esophageal Neoplasms
• Gastroesophageal Reflux

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression to esophageal adenocarcinoma		5 years (on average although follow-up will continue)	No
Secondary	Identify and validate genetic determinants that predict progression of BE to EAC and predict response to BE therapy		5 years on average	No
Secondary	Evaluate the natural history of BE with and without treatment based on clinical, functional and economic outcomes of the cases		5 years on average	No