Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00586404
Recruitment Status : Terminated (lack of enrollment)
First Posted : January 4, 2008
Last Update Posted : May 30, 2017
TAP Pharmaceutical Products Inc.
Kansas City Veteran Affairs Medical Center
Information provided by (Responsible Party):
PRATEEK SHARMA, Midwest Biomedical Research Foundation

Brief Summary:
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 or disease
Barrett's Esophagus Esophageal Neoplasms

Show Show detailed description

Layout table for study information
Study Type : Observational
Actual Enrollment : 1250 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Barrett's Esophagus Study (BEST) Trial - a Multi-Center and Endoscopic Outcomes Project
Actual Study Start Date : November 2007
Actual Primary Completion Date : May 2017
Actual Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

Patients with confirmed Barrett's Esophagus

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients who have histologically confirmed Barrett's Esophagus

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00586404

Layout table for location information
United States, Arizona
Southern Arizona VA Medical Center
Tucson, Arizona, United States, 85723
United States, Maryland
Bethesda Naval Medical Center
Bethesda, Maryland, United States, 20889
United States, Missouri
Department of Veterans Affairs Medical Center
Kansas City, Missouri, United States, 64128
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
Midwest Biomedical Research Foundation
TAP Pharmaceutical Products Inc.
Kansas City Veteran Affairs Medical Center
Layout table for investigator information
Principal Investigator: Prateek Sharma, MD Department of Veterans Affairs Medical Center of Kansas City
45. Sharma P, Reker D, Falk G, et al. Progression of Barrett's esophagus to high grade dysplasia and cancer - preliminary results of the Barrett's esophagus study trial. Gastroenterol 2001;120:A-16.
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.
58. Rosner. Fundamental of Biostatistics, New York, NY: Duxberry Press 1995.
59. Hosmer, D.W. and S. Lemeshow. Applied Logistic Regression, New York, NY: John Wiley and Sons, 1989.
60. Allison, P. D. Logistic Regression using the SAS System, Theory and Applications. Cary, NC. SAS Institute Inc, 1999.
61. Harrell, F.E. Regression Modeling Strategies with Applications to Linear Models, Logistic Regression, and Survival Analysis. New York, NY Springer, 2001.
64. Lipscomb SJ, Schoenfeld P, Johnston, Bethesda National Naval Med ctr, Bethesda. The incidence of high grade dysplasia and adenocarcinoma among patients with Barrett's esophagus: a cohort of 154 patients followed for a total of 471 patient-years. Gastroenterol 1999;116(4):A238.

Layout table for additonal information
Responsible Party: PRATEEK SHARMA, Principal Investigator, Midwest Biomedical Research Foundation Identifier: NCT00586404    
Other Study ID Numbers: PS0048
First Posted: January 4, 2008    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: May 2017
Keywords provided by PRATEEK SHARMA, Midwest Biomedical Research Foundation:
Barrett's Esophagus
Esophageal neoplasms
gastroesophageal reflux
gastrointestinal neoplasms
Additional relevant MeSH terms:
Layout table for MeSH terms
Barrett Esophagus
Esophageal Neoplasms
Precancerous Conditions
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms