Progression of Gastroesophageal Reflux Disease and Barrett's Esophagus and the Creation of a Barrett's Registry

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMidwest Biomedical Research Foundation

About this trial

The purpose of this study is to determine or evaluate the risk factors such as smoking, family history etc. that cause esophageal cancer and to determine the genetic changes that lead to esophageal cancer. The investigators hypothesis is that systematic collection of data on the natural history of GERD and BE patients and risk factors for development of BE in patients with chronic GERD and progression of BE to dysplasia and adenocarcinoma will provide useful information to develop a decision model for risk stratification and risk reduction strategies in these patients.

As of March 17, 2011, 585 patients have consented at the Kansas City VA Medical Center.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Kansas City VA Patients with confirmed BE with and without dysplasia and patients with reflux disease (patients/cases); patients with other indicators for endoscopy such as anemia, weight loss, diarrhea, but without GERD and PE (controls).

Disqualifiers

Patients with uncontrolled significant comorbidities such as cardiovascular, pulmonary, renal, hepatic or metabolic diseases.

Presence of anticoagulation that would increase risk from biopsies

Patients unable to provide history

Patients with dyspepsia

Trial population

All patients must be eligible for care at the Kansas City VA Medical Center. Those presenting to the Kansas City VA endoscopy laboratory for their "standard BE surveillance" endoscopy. Patients with a history of BE will be identified and contacted from the existing databank. Patients with newly diagnosed BE in the endoscopy laboratory after their procedure is completed and biopsy results are available. Patients undergoing upper endoscopy for evaluation of GERD symptoms. Control group of patients undergoing upper endoscopy for any reason other than the ones stated above.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

3,000 Participants
are grouped into 3 trial groups
Group A: A- Barrett's Esophagus subjects
Group B: B- gastroesophageal reflux subjects
Group C: C-subjects without BE or GERD

Trial outcomes

Primary outcomes

1

The goal of this study is to follow GERD and BE pts prospectively for development of dysplasia and adenocarcinoma, to identify factors responsible for progression of GERD to BE to dysplasia and adenocarcinoma.

Time frame
5 plus years

Secondary outcomes

1

The secondary goal is to create a tissue and serum repository for future biomarker studies.

Time frame
5 plus years

Other outcomes

Sponsors and contacts

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Midwest Biomedical Research Foundation

Lead sponsor

Kansas City Veteran Affairs Medical Center

Collaborator