The Study of Barrett's Esophagus: What Are the Factors of Progression (BEST)

This study is currently recruiting participants.

Verified October 2012 by Midwest Biomedical Research Foundation

Sponsor:

Collaborators:

TAP Pharmaceutical Products Inc.

Kansas City Veteran Affairs Medical Center

Information provided by (Responsible Party):

PRATEEK SHARMA, Midwest Biomedical Research Foundation

ClinicalTrials.gov Identifier:

NCT00586404

First received: December 21, 2007

Last updated: October 25, 2012

Last verified: October 2012

History of Changes

Purpose

This trial is a multi-center clinical and endoscopic outcomes project involving a single large database of patients with Barrett's Esophagus (BE). The initial goal of this project is to define the incidence and prevalence of cancer and high-grade dysplasia (HGD) in patients with BE. Thus, our hypothesis is that systematic collection of data on the natural history of BE and risk factors for progression of BE will provide useful information to develop a decision model for risk stratification and risk reduction strategies in BE.

Condition
Barrett's Esophagus Esophageal Neoplasms

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Barrett's Esophagus Study (BEST) Trial - a Multi-Center and Endoscopic Outcomes Project

Resource links provided by NLM:

MedlinePlus related topics: Cancer Endoscopy Esophageal Cancer Esophagus Disorders

U.S. FDA Resources

Further study details as provided by Midwest Biomedical Research Foundation:

Primary Outcome Measures:

To determine the prevalence and incidence of low grade dysplasia, high grade dysplasia and adenocarcinoma in a large cohort of patients with Barrett's esophagus [ Time Frame: up to 10 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To determine the magnitude of the contribution of selected factors (e.g. age, gender, ethnicity, obesity, tobacco use, alcohol use, ASA/NSAID/PPI use, duration of GERD symptoms, length of BE, HH) to the risk of HGD and CA [ Time Frame: up to 10 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	2500
Study Start Date:	November 2007
Estimated Study Completion Date:	November 2017
Estimated Primary Completion Date:	November 2017 (Final data collection date for primary outcome measure)

Groups/Cohorts
A Patients with confirmed Barrett's Esophagus

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Probability Sample

Study Population

Patients who have histologically confirmed Barrett's Esophagus

Criteria

Inclusion Criteria:

Sex: Male and female
Age: 18-80 years
Confirmed BE.

Exclusion Criteria:

Columnar mucosa in the distal esophagus but no intestinal metaplasia on biopsy.
Patients with BE who have undergone endoscopic ablation therapy or enrolled in chemoprevention trials. Since this is a natural history study, patients enrolled in intervention trials (e.g. those undergoing endoscopic ablation of their BE) will be excluded.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00586404

Contacts

Contact: April D Higbee, RN, BSN

816-861-4700 ext 57456

april.higbee@va.gov

Locations

United States, Arizona
Southern Arizona VA Medical Center	Recruiting
Tucson, Arizona, United States, 85723
Contact: Lisa Camargo, RN 520-192-1450 ext 5146 lisa.camargo@med.va.gov
Principal Investigator: Richard Sampliner, MD
United States, Maryland
Bethesda Naval Medical Center	Recruiting
Bethesda, Maryland, United States, 20889
Contact: Brooks Cash, MD bdcashmd@earthlink.net
Principal Investigator: Brooks Cash, MD
United States, Missouri
Department of Veterans Affairs Medical Center	Recruiting
Kansas City, Missouri, United States, 64128
Contact: April D Higbee, RN, BSN 816-861-4700 ext 57456 april.higbee@va.gov
Sub-Investigator: Ajay Bansal, MD
Sub-Investigator: Amit Rastogi, MD
Sub-Investigator: Dean Reker, PhD
Sub-Investigator: Sharad Mathur, MD
United States, Ohio
Cleveland Clinic	Recruiting
Cleveland, Ohio, United States, 44195
Contact: Christine Bodnar, RN, BSN 216-445-8524 bodnarc@ccf.org
Principal Investigator: Gary Falk, MD

Sponsors and Collaborators

Midwest Biomedical Research Foundation

TAP Pharmaceutical Products Inc.

Kansas City Veteran Affairs Medical Center

Investigators

Principal Investigator:

Prateek Sharma, MD

Department of Veterans Affairs Medical Center of Kansas City

More Information

Publications:

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Shaheen NJ, Crosby MA, Bozymski EM, Sandler RS. Is there publication bias in the reporting of cancer risk in Barrett's esophagus? Gastroenterology. 2000 Aug;119(2):333-8. Review.

Sampliner RE. Practice guidelines on the diagnosis, surveillance, and therapy of Barrett's esophagus. The Practice Parameters Committee of the American College of Gastroenterology. Am J Gastroenterol. 1998 Jul;93(7):1028-32. No abstract available.

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Reid BJ, Haggitt RC, Rubin CE, Roth G, Surawicz CM, Van Belle G, Lewin K, Weinstein WM, Antonioli DA, Goldman H, et al. Observer variation in the diagnosis of dysplasia in Barrett's esophagus. Hum Pathol. 1988 Feb;19(2):166-78.

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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.

9. Streitz JM, Andrews CW, Ellis FH. Endoscopic surveillance of Barrett's esophagus. Does it help? J Thorac Cardiovasc Surg 1993;105:383-388.

Peters JH, Clark GW, Ireland AP, Chandrasoma P, Smyrk TC, DeMeester TR. Outcome of adenocarcinoma arising in Barrett's esophagus in endoscopically surveyed and nonsurveyed patients. J Thorac Cardiovasc Surg. 1994 Nov;108(5):813-21; discussion 821-2.

Provenzale D, Schmitt C, Wong JB. Barrett's esophagus: a new look at surveillance based on emerging estimates of cancer risk. Am J Gastroenterol. 1999 Aug;94(8):2043-53.

Sharma P. Controversies in Barrett's esophagus: management of high grade dysplasia. Semin Gastrointest Dis. 2001 Jan;12(1):26-32. Review.

Levine DS, Haggitt RC, Blount PL, Rabinovitch PS, Rusch VW, Reid BJ. An endoscopic biopsy protocol can differentiate high-grade dysplasia from early adenocarcinoma in Barrett's esophagus. Gastroenterology. 1993 Jul;105(1):40-50.

Falk GW, Rice TW, Goldblum JR, Richter JE. Jumbo biopsy forceps protocol still misses unsuspected cancer in Barrett's esophagus with high-grade dysplasia. Gastrointest Endosc. 1999 Feb;49(2):170-6.

Reid BJ, Blount PL, Feng Z, Levine DS. Optimizing endoscopic biopsy detection of early cancers in Barrett's high-grade dysplasia. Am J Gastroenterol. 2000 Nov;95(11):3089-96.

Weston AP, Sharma P, Topalovski M, Richards R, Cherian R, Dixon A. Long-term follow-up of Barrett's high-grade dysplasia. Am J Gastroenterol. 2000 Aug;95(8):1888-93.

Schnell TG, Sontag SJ, Chejfec G, Aranha G, Metz A, O'Connell S, Seidel UJ, Sonnenberg A. Long-term nonsurgical management of Barrett's esophagus with high-grade dysplasia. Gastroenterology. 2001 Jun;120(7):1607-19.

Hameeteman W, Tytgat GN, Houthoff HJ, van den Tweel JG. Barrett's esophagus: development of dysplasia and adenocarcinoma. Gastroenterology. 1989 May;96(5 Pt 1):1249-56.

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Drewitz DJ, Sampliner RE, Garewal HS. The incidence of adenocarcinoma in Barrett's esophagus: a prospective study of 170 patients followed 4.8 years. Am J Gastroenterol. 1997 Feb;92(2):212-5.

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.

Rudolph RE, Vaughan TL, Storer BE, Haggitt RC, Rabinovitch PS, Levine DS, Reid BJ. Effect of segment length on risk for neoplastic progression in patients with Barrett esophagus. Ann Intern Med. 2000 Apr 18;132(8):612-20.

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.

Funkhouser EM, Sharp GB. Aspirin and reduced risk of esophageal carcinoma. Cancer. 1995 Oct 1;76(7):1116-9.

Farrow DC, Vaughan TL, Hansten PD, Stanford JL, Risch HA, Gammon MD, Chow WH, Dubrow R, Ahsan H, Mayne ST, Schoenberg JB, West AB, Rotterdam H, Fraumeni JF Jr, Blot WJ. Use of aspirin and other nonsteroidal anti-inflammatory drugs and risk of esophageal and gastric cancer. Cancer Epidemiol Biomarkers Prev. 1998 Feb;7(2):97-102.

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.

Lagergren J, Bergström R, Nyrén O. Association between body mass and adenocarcinoma of the esophagus and gastric cardia. Ann Intern Med. 1999 Jun 1;130(11):883-90.

Gammon MD, Schoenberg JB, Ahsan H, Risch HA, Vaughan TL, Chow WH, Rotterdam H, West AB, Dubrow R, Stanford JL, Mayne ST, Farrow DC, Niwa S, Blot WJ, Fraumeni JF Jr. Tobacco, alcohol, and socioeconomic status and adenocarcinomas of the esophagus and gastric cardia. J Natl Cancer Inst. 1997 Sep 3;89(17):1277-84.

Chow WH, Blaser MJ, Blot WJ, Gammon MD, Vaughan TL, Risch HA, Perez-Perez GI, Schoenberg JB, Stanford JL, Rotterdam H, West AB, Fraumeni JF Jr. An inverse relation between cagA+ strains of Helicobacter pylori infection and risk of esophageal and gastric cardia adenocarcinoma. Cancer Res. 1998 Feb 15;58(4):588-90.

Vicari JJ, Peek RM, Falk GW, Goldblum JR, Easley KA, Schnell J, Perez-Perez GI, Halter SA, Rice TW, Blaser MJ, Richter JE. The seroprevalence of cagA-positive Helicobacter pylori strains in the spectrum of gastroesophageal reflux disease. Gastroenterology. 1998 Jul;115(1):50-7.

Cameron AJ, Lomboy CT. Barrett's esophagus: age, prevalence, and extent of columnar epithelium. Gastroenterology. 1992 Oct;103(4):1241-5.

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.

Lagergren J, Bergström R, Lindgren A, Nyrén O. Symptomatic gastroesophageal reflux as a risk factor for esophageal adenocarcinoma. N Engl J Med. 1999 Mar 18;340(11):825-31.

Lagergren J, Bergström R, Adami HO, Nyrén 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.

Freedman J, Ye W, Näslund E, Lagergren J. Association between cholecystectomy and adenocarcinoma of the esophagus. Gastroenterology. 2001 Sep;121(3):548-53.

Weston AP, Badr AS, Hassanein RS. Prospective multivariate analysis of clinical, endoscopic, and histological factors predictive of the development of Barrett's multifocal high-grade dysplasia or adenocarcinoma. Am J Gastroenterol. 1999 Dec;94(12):3413-9.

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.

Katz D, Rothstein R, Schned A, Dunn J, Seaver K, Antonioli D. The development of dysplasia and adenocarcinoma during endoscopic surveillance of Barrett's esophagus. Am J Gastroenterol. 1998 Apr;93(4):536-41.

Sharma P, Sampliner RE, Camargo E. Normalization of esophageal pH with high-dose proton pump inhibitor therapy does not result in regression of Barrett's esophagus. Am J Gastroenterol. 1997 Apr;92(4):582-5.

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.

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Csendes A, Braghetto I, Burdiles P, Puente G, Korn O, Díaz JC, Maluenda F. Long-term results of classic antireflux surgery in 152 patients with Barrett's esophagus: clinical, radiologic, endoscopic, manometric, and acid reflux test analysis before and late after operation. Surgery. 1998 Jun;123(6):645-57.

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46. Sharma P, Weston AP, Falk G, Johnston M, Reker D, Sampliner RE. Can two upper endoscopies negative for dysplasia eliminate the need for future surveillance in patients with Barrett's esophagus? Am J Gastroenterol 2001;96:(Supplement)109.

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Responsible Party:	PRATEEK SHARMA, Principal Investigator, Midwest Biomedical Research Foundation
ClinicalTrials.gov Identifier:	NCT00586404 History of Changes
Other Study ID Numbers:	PS0048
Study First Received:	December 21, 2007
Last Updated:	October 25, 2012
Health Authority:	United States: Federal Government

Keywords provided by Midwest Biomedical Research Foundation:

Barrett's Esophagus
Esophageal neoplasms
gastroesophageal reflux
gastrointestinal neoplasms

Additional relevant MeSH terms:

Barrett Esophagus
Neoplasms
Esophageal Diseases
Esophageal Neoplasms
Digestive System Abnormalities
Digestive System Diseases

Gastrointestinal Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms

ClinicalTrials.gov processed this record on May 23, 2013

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