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

NCT00574327 | Recruiting

• 1 other identifier: PS0035
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief Summary

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

Barrett's Esophagus; Gastroesophageal Reflux Disease; Esophageal Adenocarcinoma

Keywords

Role; Registry; Barrett's Esophagus

Outcome Measures

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.

  5 plus years

Secondary Outcomes (1)

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

  5 plus years

Study Arms (3)

A- Barrett's Esophagus subjects

Patients with documented Barrett's Esophagus with or without dysplasia (LGD or HGD) that will undergo surveillance endoscopies dictated by the grade of dysplasia.

B- gastroesophageal reflux subjects

Patients undergoing endoscopy for evaluation of GERD symptoms.

C-subjects without BE or GERD

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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 may not qualify 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

Sponsors & Collaborators

• Midwest Biomedical Research Foundation: lead
• Kansas City Veteran Affairs Medical Center: collaborator

Study Sites (1)

Department of Veterans Affairs Medical Center

Kansas City, Missouri, 64128, United States

RECRUITING

Related Publications (33)

• Sampliner 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 BACKGROUND

• Haggitt 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 BACKGROUND

• Reid BJ. Barrett's esophagus and esophageal adenocarcinoma. Gastroenterol Clin North Am. 1991 Dec;20(4):817-34.

  PMID: 1787015 BACKGROUND

• van 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 BACKGROUND

• Gudlaugsdottir 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 BACKGROUND

• van 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 BACKGROUND

• O'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 BACKGROUND

• 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.

  PMID: 15645398 BACKGROUND

• Shirvani VN, Ouatu-Lascar R, Kaur BS, Omary MB, Triadafilopoulos G. Cyclooxygenase 2 expression in Barrett's esophagus and adenocarcinoma: Ex vivo induction by bile salts and acid exposure. Gastroenterology. 2000 Mar;118(3):487-96. doi: 10.1016/s0016-5085(00)70254-x.

  PMID: 10702199 BACKGROUND

• Wilson KT, Fu S, Ramanujam KS, Meltzer SJ. Increased expression of inducible nitric oxide synthase and cyclooxygenase-2 in Barrett's esophagus and associated adenocarcinomas. Cancer Res. 1998 Jul 15;58(14):2929-34.

  PMID: 9679948 BACKGROUND

• Rabinovitch PS, Longton G, Blount PL, Levine DS, Reid BJ. Predictors of progression in Barrett's esophagus III: baseline flow cytometric variables. Am J Gastroenterol. 2001 Nov;96(11):3071-83. doi: 10.1111/j.1572-0241.2001.05261.x.

  PMID: 11721752 BACKGROUND

• Reid BJ, Levine DS, Longton G, Blount PL, Rabinovitch PS. Predictors of progression to cancer in Barrett's esophagus: baseline histology and flow cytometry identify low- and high-risk patient subsets. Am J Gastroenterol. 2000 Jul;95(7):1669-76. doi: 10.1111/j.1572-0241.2000.02196.x.

  PMID: 10925966 BACKGROUND

• Cameron AJ, Lomboy CT. Barrett's esophagus: age, prevalence, and extent of columnar epithelium. Gastroenterology. 1992 Oct;103(4):1241-5. doi: 10.1016/0016-5085(92)91510-b.

  PMID: 1397881 BACKGROUND

• El-Serag HB, Petersen NJ, Carter J, Graham DY, Richardson P, Genta RM, Rabeneck L. Gastroesophageal reflux among different racial groups in the United States. Gastroenterology. 2004 Jun;126(7):1692-9. doi: 10.1053/j.gastro.2004.03.077.

  PMID: 15188164 BACKGROUND

• Younes M, Henson DE, Ertan A, Miller CC. Incidence and survival trends of esophageal carcinoma in the United States: racial and gender differences by histological type. Scand J Gastroenterol. 2002 Dec;37(12):1359-65. doi: 10.1080/003655202762671215.

  PMID: 12523583 BACKGROUND

• Lagergren J, Bergstrom R, Lindgren A, Nyren O. Symptomatic gastroesophageal reflux as a risk factor for esophageal adenocarcinoma. N Engl J Med. 1999 Mar 18;340(11):825-31. doi: 10.1056/NEJM199903183401101.

  PMID: 10080844 BACKGROUND

• Gray MR, Donnelly RJ, Kingsnorth AN. The role of smoking and alcohol in metaplasia and cancer risk in Barrett's columnar lined oesophagus. Gut. 1993 Jun;34(6):727-31. doi: 10.1136/gut.34.6.727.

  PMID: 8314502 BACKGROUND

• Vaughan TL, Davis S, Kristal A, Thomas DB. Obesity, alcohol, and tobacco as risk factors for cancers of the esophagus and gastric cardia: adenocarcinoma versus squamous cell carcinoma. Cancer Epidemiol Biomarkers Prev. 1995 Mar;4(2):85-92.

  PMID: 7742727 BACKGROUND

• Terry P, Lagergren J, Hansen H, Wolk A, Nyren O. Fruit and vegetable consumption in the prevention of oesophageal and cardia cancers. Eur J Cancer Prev. 2001 Aug;10(4):365-9. doi: 10.1097/00008469-200108000-00010.

  PMID: 11535879 BACKGROUND

• Chow WH, Blot WJ, Vaughan TL, Risch HA, Gammon MD, Stanford JL, Dubrow R, Schoenberg JB, Mayne ST, Farrow DC, Ahsan H, West AB, Rotterdam H, Niwa S, Fraumeni JF Jr. Body mass index and risk of adenocarcinomas of the esophagus and gastric cardia. J Natl Cancer Inst. 1998 Jan 21;90(2):150-5. doi: 10.1093/jnci/90.2.150.

  PMID: 9450576 BACKGROUND

• Moe GL, Kristal AR, Levine DS, Vaughan TL, Reid BJ. Waist-to-hip ratio, weight gain, and dietary and serum selenium are associated with DNA content flow cytometry in Barrett's esophagus. Nutr Cancer. 2000;36(1):7-13. doi: 10.1207/S15327914NC3601_2.

  PMID: 10798210 BACKGROUND

• Romero Y, Cameron AJ, Locke GR 3rd, Schaid DJ, Slezak JM, Branch CD, Melton LJ 3rd. Familial aggregation of gastroesophageal reflux in patients with Barrett's esophagus and esophageal adenocarcinoma. Gastroenterology. 1997 Nov;113(5):1449-56. doi: 10.1053/gast.1997.v113.pm9352846.

  PMID: 9352846 BACKGROUND

• Lagergren J, Bergstrom R, Adami HO, Nyren O. Association between medications that relax the lower esophageal sphincter and risk for esophageal adenocarcinoma. Ann Intern Med. 2000 Aug 1;133(3):165-75. doi: 10.7326/0003-4819-133-3-200008010-00007.

  PMID: 10906830 BACKGROUND

• El-Serag HB, Aguirre TV, Davis S, Kuebeler M, Bhattacharyya A, Sampliner RE. Proton pump inhibitors are associated with reduced incidence of dysplasia in Barrett's esophagus. Am J Gastroenterol. 2004 Oct;99(10):1877-83. doi: 10.1111/j.1572-0241.2004.30228.x.

  PMID: 15447744 BACKGROUND

• Corley DA, Kerlikowske K, Verma R, Buffler P. Protective association of aspirin/NSAIDs and esophageal cancer: a systematic review and meta-analysis. Gastroenterology. 2003 Jan;124(1):47-56. doi: 10.1053/gast.2003.50008.

  PMID: 12512029 BACKGROUND

• Freedman J, Ye W, Naslund E, Lagergren J. Association between cholecystectomy and adenocarcinoma of the esophagus. Gastroenterology. 2001 Sep;121(3):548-53. doi: 10.1053/gast.2001.27217.

  PMID: 11522738 BACKGROUND

• McDonald ML, Trastek VF, Allen MS, Deschamps C, Pairolero PC, Pairolero PC. Barretts's esophagus: does an antireflux procedure reduce the need for endoscopic surveillance? J Thorac Cardiovasc Surg. 1996 Jun;111(6):1135-8; discussion 1139-40. doi: 10.1016/s0022-5223(96)70214-3.

  PMID: 8642813 BACKGROUND

• Trujillo ME, Scherer PE. Adiponectin--journey from an adipocyte secretory protein to biomarker of the metabolic syndrome. J Intern Med. 2005 Feb;257(2):167-75. doi: 10.1111/j.1365-2796.2004.01426.x.

  PMID: 15656875 BACKGROUND

• Weston AP, Sharma P, Mathur S, Banerjee S, Jafri AK, Cherian R, McGregor D, Hassanein RS, Hall M. Risk stratification of Barrett's esophagus: updated prospective multivariate analysis. Am J Gastroenterol. 2004 Sep;99(9):1657-66. doi: 10.1111/j.1572-0241.2004.30426.x.

  PMID: 15330898 BACKGROUND

• Weston AP, Badr AS, Topalovski M, Cherian R, Dixon A, Hassanein RS. Prospective evaluation of the prevalence of gastric Helicobacter pylori infection in patients with GERD, Barrett's esophagus, Barrett's dysplasia, and Barrett's adenocarcinoma. Am J Gastroenterol. 2000 Feb;95(2):387-94. doi: 10.1111/j.1572-0241.2000.01758.x.

  PMID: 10685740 BACKGROUND

• Kan T, Shimada Y, Sato F, Maeda M, Kawabe A, Kaganoi J, Itami A, Yamasaki S, Imamura M. Gene expression profiling in human esophageal cancers using cDNA microarray. Biochem Biophys Res Commun. 2001 Aug 31;286(4):792-801. doi: 10.1006/bbrc.2001.5400.

  PMID: 11520067 BACKGROUND

• Souza RF, Morales CP, Spechler SJ. Review article: a conceptual approach to understanding the molecular mechanisms of cancer development in Barrett's oesophagus. Aliment Pharmacol Ther. 2001 Aug;15(8):1087-100. doi: 10.1046/j.1365-2036.2001.01046.x.

  PMID: 11472311 BACKGROUND

• Bansal A, Lee IH, Hong X, Anand V, Mathur SC, Gaddam S, Rastogi A, Wani SB, Gupta N, Visvanathan M, Sharma P, Christenson LK. Feasibility of mcroRNAs as biomarkers for Barrett's Esophagus progression: a pilot cross-sectional, phase 2 biomarker study. Am J Gastroenterol. 2011 Jun;106(6):1055-63. doi: 10.1038/ajg.2011.37. Epub 2011 Mar 15.

  PMID: 21407181 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Serum samples from participating patients will be collected and frozen for measurements of insulin, glucose, lipid panel, CRP and adiponectin levels. Biopsies obtained from esophagus during endoscopy and blood samples will be frozen for future biomarker and cDNA microarray studies and histochemistry.

MeSH Terms

Conditions

Barrett Esophagus; Gastroesophageal Reflux; Adenocarcinoma Of Esophagus

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Esophageal Motility Disorders; Deglutition Disorders

Study Officials

• Prateek Sharma, MD

  Department of Veterans Affairs Medical Center of Kansas City

  PRINCIPAL INVESTIGATOR

Central Study Contacts

April D Higbee, RN, BSN

CONTACT

816-861-4700; april.higbee@va.gov

Carly Campbell, MS

CONTACT

816-861-4700; Carlissa.Campbell@va.gov

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 14, 2007
• First Posted: December 17, 2007
• Study Start: January 1, 2006
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): January 1, 2029
• Last Updated: March 16, 2023

Record last verified: 2023-03

Locations

US (1)