Clinical trial · Observational
Progression of Gastroesophageal Reflux Disease and Barrett's Esophagus and the Creation of a Barrett's Registry
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Barrett's Esophagus | — | UNRESOLVED | — |
| Esophageal Adenocarcinoma | Esophageal Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Gastroesophageal Reflux Disease | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (3)
- label
- A- Barrett's Esophagus subjects
- description
- Patients with documented Barrett's Esophagus with or without dysplasia (LGD or HGD) that will undergo surveillance endoscopies dictated by the grade of dysplasia.
- label
- B- gastroesophageal reflux subjects
- description
- Patients undergoing endoscopy for evaluation of GERD symptoms.
- label
- C-subjects without BE or GERD
- description
- The control group would include patients undergoing upper endoscopy for reasons other than stated above, such as evaluation of iron deficiency anemia, weight loss, positive fecal occult blood, etc.
Primary outcomes (1)
- measure
- 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.
- timeFrame
- 5 plus years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
All patients must be eligible for care that the Kansas City VA Hospital where this study was approved for enrollment. Inclusion Criteria: * 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). Exclusion Criteria: * 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
References
Publications (33)
- BACKGROUNDSampliner RE; Practice Parameters Committee of the American College of Gastroenterology. Updated guidelines for the diagnosis, surveillance, and therapy of Barrett's esophagus. Am J Gastroenterol. 2002 Aug;97(8):1888-95. doi: 10.1111/j.1572-0241.2002.05910.x. No abstract available. PMID 12190150
- BACKGROUNDHaggitt RC. Barrett's esophagus, dysplasia, and adenocarcinoma. Hum Pathol. 1994 Oct;25(10):982-93. doi: 10.1016/0046-8177(94)90057-4. PMID 7927321
- BACKGROUNDReid BJ. Barrett's esophagus and esophageal adenocarcinoma. Gastroenterol Clin North Am. 1991 Dec;20(4):817-34. PMID 1787015
- BACKGROUNDvan Sandick JW, van Lanschot JJ, Kuiken BW, Tytgat GN, Offerhaus GJ, Obertop H. Impact of endoscopic biopsy surveillance of Barrett's oesophagus on pathological stage and clinical outcome of Barrett's carcinoma. Gut. 1998 Aug;43(2):216-22. doi: 10.1136/gut.43.2.216. PMID 10189847
- BACKGROUNDGudlaugsdottir S, van Blankenstein M, Dees J, Wilson JH. A majority of patients with Barrett's oesophagus are unlikely to benefit from endoscopic cancer surveillance. Eur J Gastroenterol Hepatol. 2001 Jun;13(6):639-45. doi: 10.1097/00042737-200106000-00005. PMID 11434588
- BACKGROUNDvan der Burgh A, Dees J, Hop WC, van Blankenstein M. Oesophageal cancer is an uncommon cause of death in patients with Barrett's oesophagus. Gut. 1996 Jul;39(1):5-8. doi: 10.1136/gut.39.1.5. PMID 8881798
- BACKGROUNDO'Connor JB, Falk GW, Richter JE. The incidence of adenocarcinoma and dysplasia in Barrett's esophagus: report on the Cleveland Clinic Barrett's Esophagus Registry. Am J Gastroenterol. 1999 Aug;94(8):2037-42. doi: 10.1111/j.1572-0241.1999.01275.x. PMID 10445525
- Wong A, Fitzgerald RC. Epidemiologic risk factors for Barrett's esophagus and associated adenocarcinoma. Clin Gastroenterol Hepatol. 2005 Jan;3(1):1-10. doi: 10.1016/s1542-3565(04)00602-0.