Epidemiology of Barrett's Esophagus: A Population Based Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01286155

Enrollment

534

Registered

2011-01-31

Start date

2010-01-31

Completion date

2011-06-30

Last updated

2013-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Barrett's esophagus, gastroesophageal reflux disease, GERD

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 95 Years

Healthy volunteers

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; -

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame	Description
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).

Countries

United States

Outcome results