Epidemiology of Barrett's Esophagus: A Population Based Study

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

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Key information

Conditions

Barrett's Esophagus Barrett Esophagus Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastroesophageal Reflux Disease (GERD) Gastrointestinal Diseases Neoplasms Olmsted County Resident Precancerous Conditions

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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; -

Treatment and study plan

Primary outcomes

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

Secondary outcomes

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
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).

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

American College of Gastroenterology

Registry information

Important dates

Study start: 2010
Primary completion: 2011
Study completion: 2011
First posted: Jan 31, 2011
Registry last updated: May 6, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed