What this study is
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.
Study details
- Official title
- A Prospective Study To Define The Role Of Various Factors In Development And Progression Of Gastroesophageal Reflux Disease (GERD) And Barrett's Esophagus And The Creation Of A Registry.
- Sponsor
- Midwest Biomedical Research Foundation
- Conditions
- Barrett's Esophagus · Gastroesophageal Reflux Disease · Esophageal Adenocarcinoma
- Enrolling
- 3,000 people
- Starts
- 2006-01
- Est. completion
- 2029-01
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers AcceptedYou may qualify if
- All patients must be eligible for care that the Kansas City VA Hospital where this study was approved for enrollment.
- 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).
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openDepartment of Veterans Affairs Medical Center
Kansas City, Missouri, United States
- Prateek Sharma, MD · Principal investigator
- Sharad Mathur, MD · Sub-investigator
- Prashant Pandya, DO · Sub-investigator
Recruiting
Study team
Sponsor
Midwest Biomedical Research Foundation
Study ID PS0035
Principal investigator
Prateek Sharma, MD
Department of Veterans Affairs Medical Center of Kansas City
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.