Epidemiology of Barrett's Esophagus: A Population Based Study

NCT01286155 | Completed

• 1 other identifier: 09-002718
• Study Type: observational
• Target: 534
• Locations: 1 country
• Sites: 1

Brief Summary

To assess attitudes toward screening for esophageal adenocarcinoma (EAC) and Barrett's esophagus (BE) in the community. To develop a population based clinical risk factor prediction model for the diagnosis of BE and identify novel risk factors for BE which would make population based screening more efficient. This will be an important first step in identifying the target population for BE screening, another crucial component of making screening feasible and efficient

Conditions

Barrett's Esophagus; Gastroesophageal Reflux Disease (GERD); Olmsted County Resident

Keywords

Barrett's esophagus; gastroesophageal reflux disease; GERD

Outcome Measures

Primary Outcomes (1)

• The primary outcome from the survey will be the proportion of patients willing to undergo an esophageal capsule study compared to those willing to undergo an endoscopic procedure (Esophagogastroduodenoscopy or transnasal endoscopy)

  18 months

Secondary Outcomes (1)

• Study established (age, gender, ethnicity, reflux) and potential risk factors (sleep apnea, visceral adiposity, Helicobacter pylori infection, Metabolic Syndrome)to develop a clinical risk factor model for diagnosis of Barrett's esophagus(BE).

  18 months

Study Arms (3)

with gastroesophageal reflux disease(GERD)

Subjects with gastroesophageal reflux disease (GERD)

Non-GERD

Subjects with no history of gastroesophageal reflux disease (GERD)

Barrett's esophagus

Subjects with confirmed barrett's esophagus in Olmsted county

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Olmsted county resident

You may qualify if:

• Case: Olmsted county residents \> 18 years old from the barrett's esophagus (BE) incidence cohort who are still alive at the time of study.
• Control # 1 : Olmsted county residents \> 18 years old that responded to a recent community based survey and reported gastroesophageal reflux (GER) symptoms at least once a week and without a known diagnosis of BE.
• Control # 2 : Olmsted county residents \> 18 years old that responded to a recent community based survey that did not report any GER symptoms and without a known diagnosis of BE.

You may not qualify if:

• Cases: BE subjects who
• Have died prior to the start of this study;
• Refuse to participate;
• Controls: respondents to the "constipation survey" who
• Are known to have BE;
• Have died prior to the start of this study;
• Refuse to participate; -

Sponsors & Collaborators

• Mayo Clinic: lead
• American College of Gastroenterology: collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Barrett Esophagus; Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Esophageal Motility Disorders; Deglutition Disorders

Study Design

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

Study Record Dates

• First Submitted: January 26, 2011
• First Posted: January 31, 2011
• Study Start: January 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: May 6, 2013

Record last verified: 2013-05

Locations

US (1)