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

Tracking Information
First Received Date ^ICMJE	January 26, 2011
Last Updated Date	May 3, 2013
Start Date ^ICMJE	January 2010
Primary Completion Date	June 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 27, 2011)	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 ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01286155 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: January 27, 2011)	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: 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).
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Epidemiology of Barrett's Esophagus: A Population Based Study
Official Title ^ICMJE	Epidemiology of Barrett's Esophagus: A Population Based Study
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
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Cohort Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Retention: Samples With DNA Description: Blood
Sampling Method	Non-Probability Sample
Study Population	Olmsted county resident
Condition ^ICMJE	Barrett's Esophagus Gastroesophageal Reflux Disease (GERD) Olmsted County Resident
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	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
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	534
Completion Date	June 2011
Primary Completion Date	June 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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; -
Gender	Both
Ages	18 Years to 95 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01286155
Other Study ID Numbers ^ICMJE	09-002718
Has Data Monitoring Committee	No
Responsible Party	Prasad G. Iyer, Mayo Clinic
Study Sponsor ^ICMJE	Mayo Clinic
Collaborators ^ICMJE	American College of Gastroenterology
Investigators ^ICMJE	Not Provided
Information Provided By	Mayo Clinic
Verification Date	May 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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