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 volunteersQualifiers
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
Case-control
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
The secondary goal is to create a tissue and serum repository for future biomarker studies.
Sponsors and contacts
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Midwest Biomedical Research Foundation
Lead sponsor
Kansas City Veteran Affairs Medical Center
Collaborator