Barrett's EsophagusNCT01286155
Epidemiology of Barrett's Esophagus: A Population Based Study
An observational study of Barrett's Esophagus and Gastroesophageal Reflux Disease (GERD), run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Barrett's Esophagus, Gastroesophageal Reflux Disease (GERD), Olmsted County Resident
- How many people
- 534 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Jun 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Olmsted county resident
Who may be able to join
- 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.
Who cannot join
- 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; -
Trial locations and contacts
1 site in 1 country.
About this 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
- Keywords
- Barrett's esophagus, gastroesophageal reflux disease, GERD
- Medical subject headings
- Barrett Esophagus, Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 18 months
Secondary outcomes (1)
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).
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).
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2011 (estimated)
- Study startJan 2010
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Barrett's EsophagusStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 534 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- American College of Gastroenterology
- Responsible party
- Principal investigator, Prasad G. Iyer, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01286155
- Sponsor's protocol ID
- 09-002718
- Status last verified
- May 2013
- First submitted
- 26 Jan 2011
- Last updated
- 6 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology of Barrett's Esophagus: A Population Based Study
- ClinicalTrials.gov ID
- NCT01286155
- Acronym / sponsor ID
- 09-002718
- Keywords
- Barrett's esophagus, gastroesophageal reflux disease, GERD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 534 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- American College of Gastroenterology
- Study start
- Jan 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 31 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Olmsted county resident
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- Cases: BE subjects who
- Controls: respondents to the "constipation survey" who
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Barrett's Esophagus and Gastroesophageal Reflux Disease (GERD), run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2013.