Epidemiology of Barrett's Esophagus: A Population Based Study

Completed

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

• Registration Number: NCT01286155
• Lead Sponsor: Mayo Clinic

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2011-01-26
• Study First Submitted QC: 2011-01-27
• Study First Posted: 2011-01-31
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-03
• Last Update Posted: 2013-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 534

Inclusion Criteria

1. Case: Olmsted county residents > 18 years old from the barrett's esophagus (BE) incidence cohort who are still alive at the time of study.
2. 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.
3. 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.

Exclusion Criteria

1. Cases: BE subjects who

   1. Have died prior to the start of this study;
   2. Refuse to participate;

2. Controls: respondents to the "constipation survey" who

   1. Are known to have BE;
   2. Have died prior to the start of this study;
   3. Refuse to participate; -

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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	Metabolic Syndrome (ATP III criteria, JAMA 2001; 285: 2486-97.) defined as a combination of clinical disorders that includes the presence of three or more of the following indicators: 1. abdominal obesity (waist circumference \> 102 cm in men, \> 88 cm in women); 2. high triglyceride level (≥ 150 mg/dL); 3. low level of high density lipoprotein (\< 40 mg/dL in men; \< 50 mg/dL in women); 4. high blood pressure (≥ 130/85 mmHg); 5. high fasting plasma glucose (≥ 110 mg/dL).

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States