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

This study is currently recruiting participants. (see Contacts and Locations)
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
  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:


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
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 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:
9. Streitz JM, Andrews CW, Ellis FH. Endoscopic surveillance of Barrett's esophagus. Does it help? J Thorac Cardiovasc Surg 1993;105:383-388.
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.
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
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:
Neoplasms
Barrett Esophagus
Esophageal Neoplasms
Digestive System Abnormalities
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms

ClinicalTrials.gov processed this record on September 18, 2014