- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01286155
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
Study Overview
Status
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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; -
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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with gastroesophageal reflux disease(GERD)
Subjects with gastroesophageal reflux disease (GERD)
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Non-GERD
Subjects with no history of gastroesophageal reflux disease (GERD)
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Barrett's esophagus
Subjects with confirmed barrett's esophagus in Olmsted county
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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18 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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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:
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18 months
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09-002718
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Barrett's Esophagus
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Northwell HealthMayo Clinic; NinePoint MedicalCompletedBarrett's Esophagus Without Dysplasia | Barrett's Esophagus With Dysplasia | Barrett's Esophagus With Low Grade Dysplasia | Barrett's Esophagus With High Grade Dysplasia | Barrett's Esophagus With Dysplasia, UnspecifiedUnited States
-
Case Comprehensive Cancer CenterCompletedShort Segment Barrett's Esophagus | Long Segment Barrett's EsophagusUnited States
-
The Guthrie ClinicActive, not recruiting
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Interscope, Inc.RecruitingBarrett's Esophagus With DysplasiaUnited States, Sweden, United Kingdom
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Mayo ClinicCompletedBarrett's Esophagus With DysplasiaUnited States
-
Massachusetts General HospitalEnrolling by invitationBarrett Esophagus | Barrett's Esophagus Without Dysplasia | Barretts Esophagus With DysplasiaUnited States
-
Lucid Diagnostics, Inc.CompletedBarrett Esophagus | Esophageal Adenocarcinoma | Barrett's Esophagus Without Dysplasia | Barretts Esophagus With DysplasiaUnited States, Spain
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University of CambridgeUniversity of NottinghamRecruitingBarrett's OesophagusUnited Kingdom
-
Johns Hopkins UniversityAmerican Society for Gastrointestinal Endoscopy; Pentax Medical CorporationCompletedBarrett's Esophagus, Esophageal Intraepithelial NeoplasiaUnited States, Germany
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Mayo ClinicFred Hutchinson Cancer CenterCompletedBarrett's Esophagus With High Grade Dsyplasia | Early Esophageal CancerUnited States