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

This study has suspended participant recruitment.
(The protocol is being reviewed and potentially revised. Recruitment is currently suspended.)
TAP Pharmaceutical Products Inc.
Kansas City Veteran Affairs Medical Center
Information provided by (Responsible Party):
PRATEEK SHARMA, Midwest Biomedical Research Foundation Identifier:
First received: December 21, 2007
Last updated: October 19, 2015
Last verified: October 2015
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.

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:

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)
Patients with confirmed Barrett's Esophagus

  Show Detailed Description


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

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
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00586404

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
Principal Investigator: Prateek Sharma, MD Department of Veterans Affairs Medical Center of Kansas City
  More Information

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.

Responsible Party: PRATEEK SHARMA, Principal Investigator, Midwest Biomedical Research Foundation Identifier: NCT00586404     History of Changes
Other Study ID Numbers: PS0048
Study First Received: December 21, 2007
Last Updated: October 19, 2015
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
Esophageal Neoplasms
Digestive System Abnormalities
Digestive System Diseases
Digestive System Neoplasms
Esophageal Diseases
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Head and Neck Neoplasms
Neoplasms by Site processed this record on November 27, 2015