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

January 26, 2011
May 3, 2013
January 2010
June 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01286155 on ClinicalTrials.gov Archive Site
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).
Same as current
Not Provided
Not Provided
 
Epidemiology of Barrett's Esophagus: A Population Based Study
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

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Blood

Non-Probability Sample

Olmsted county resident

  • Barrett's Esophagus
  • Gastroesophageal Reflux Disease (GERD)
  • Olmsted County Resident
Not Provided
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
534
June 2011
June 2011   (final data collection date for primary outcome measure)

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; -
Both
18 Years to 95 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01286155
09-002718
No
Prasad G. Iyer, Mayo Clinic
Mayo Clinic
American College of Gastroenterology
Not Provided
Mayo Clinic
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP