Epidemiology of Barrett's Esophagus: A Population Based Study

Barrett's Esophagus Clinical Trial

Official title:

Epidemiology of Barrett's Esophagus: A Population Based Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01286155
• Other study ID #: 09-002718
• Status: Completed
• Phase: N/A
• First received: January 26, 2011
• Last updated: May 3, 2013
• Start date: January 2010
• Est. completion date: June 2011

Study information

• Verified date: May 2013
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 534
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 95 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	American College of Gastroenterology

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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).	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: abdominal obesity (waist circumference > 102 cm in men, > 88 cm in women); high triglyceride level (= 150 mg/dL); low level of high density lipoprotein (< 40 mg/dL in men; < 50 mg/dL in women); high blood pressure (= 130/85 mmHg); high fasting plasma glucose (= 110 mg/dL).	18 months	No