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Epidemiology of Barrett's Esophagus: A Population Based Study

This study has been completed.
Sponsor:
Collaborator:
American College of Gastroenterology
Information provided by (Responsible Party):
Prasad G. Iyer, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01286155
First received: January 26, 2011
Last updated: May 3, 2013
Last verified: May 2013
History of Changes
  Purpose

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


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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Epidemiology of Barrett's Esophagus: A Population Based Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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) [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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). [ Time Frame: 18 months ] [ Designated as safety issue: No ]

    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).


Biospecimen Retention:   Samples With DNA

Blood


Enrollment: 534
Study Start Date: January 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Olmsted county resident

Criteria

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; -
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01286155

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
American College of Gastroenterology
  More Information

No publications provided

Responsible Party: Prasad G. Iyer, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01286155     History of Changes
Other Study ID Numbers: 09-002718
Study First Received: January 26, 2011
Last Updated: May 3, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Barrett's esophagus
gastroesophageal reflux disease
GERD

Additional relevant MeSH terms:
Barrett Esophagus
Gastroesophageal Reflux
Digestive System Abnormalities
Digestive System Diseases
 Esophageal Diseases
Gastrointestinal Diseases
Esophageal Motility Disorders
Deglutition Disorders

ClinicalTrials.gov processed this record on May 22, 2013