Recruiting

Observational Study

Sponsor:

Massachusetts General Hospital

Code:

NCT01776346

Conditions

Barrett Esophagus

Esophageal Adenocarcinoma

Gastroesophageal Reflux

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Study Details

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.

Conditions

Barrett Esophagus

Esophageal Adenocarcinoma

Gastroesophageal Reflux

Study ID

NCT01776346

Start date

Jan, 2011

Status verified date

Jan, 2013

Completion date

Dec, 2021

Anticipated

Primary completion date

Dec, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Enrollment

750 participants

Anticipated

Interventions and Outcome Measures

Arms

Barrett's Esophagus/Esophageal Adenocarcinoma

Patients who have Barrett's esophagus or esophageal adenocarcinoma.

Healthy control

Primary outcome measure

  • Progression to esophageal adenocarcinoma [ Time Frame: 5 years (on average although follow-up will continue) ]

Central Contacts and Locations

Central contacts

Katherine Perzan, BA

617-726-1431kperzan@partners.org

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Katherine Perzan, BA

617-726-1431kperzan@partners.org

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Jan 28, 2013

Last verified

Jan, 2013

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2013-01-28.