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

NCT00586404 | Terminated DMC

• 1 other identifier: PS0048
• Study Type: observational
• Target: 1,250
• Locations: 1 country
• Sites: 4

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.

Conditions

Barrett's Esophagus; Esophageal Neoplasms

Keywords

Barrett's Esophagus; Esophageal neoplasms; gastroesophageal reflux; gastrointestinal neoplasms

Outcome Measures

Primary Outcomes (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

  up to 10 years

Secondary Outcomes (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

  up to 10 years

Study Arms (1)

A

Patients with confirmed Barrett's Esophagus

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who have histologically confirmed Barrett's Esophagus

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Midwest Biomedical Research Foundation: lead
• TAP Pharmaceutical Products Inc.: collaborator
• Kansas City Veteran Affairs Medical Center: collaborator

Study Sites (4)

Southern Arizona VA Medical Center

Tucson, Arizona, 85723, United States

Location

Bethesda Naval Medical Center

Bethesda, Maryland, 20889, United States

Location

Department of Veterans Affairs Medical Center

Kansas City, Missouri, 64128, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Publications (63)

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  BACKGROUND

MeSH Terms

Conditions

Barrett Esophagus; Esophageal Neoplasms; Gastroesophageal Reflux; Gastrointestinal Neoplasms

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Esophageal Motility Disorders; Deglutition Disorders

Study Officials

• Prateek Sharma, MD

  Department of Veterans Affairs Medical Center of Kansas City

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 21, 2007
• First Posted: January 4, 2008
• Study Start: November 1, 2007
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: May 30, 2017

Record last verified: 2017-05

Locations

US (4)