Barrett's Esophagus Patient Registry

NCT ID: NCT01776346

Last Updated: 2013-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

750 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-31

Study Completion Date

2021-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Barrett Esophagus Esophageal Adenocarcinoma Gastroesophageal Reflux

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Barrett's Esophagus/Esophageal Adenocarcinoma

Patients who have Barrett's esophagus or esophageal adenocarcinoma.

No interventions assigned to this group

Healthy control

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Chin Hur

Principal Investigator; MD, MPH

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Katherine Perzan, BA

Role: CONTACT

617-726-1431

Facility Contacts

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Katherine Perzan, BA

Role: primary

617-726-1431

Other Identifiers

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2010P002224

Identifier Type: -

Identifier Source: org_study_id

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