Barrett's EsophagusCR20NCT01281618
Influence of Acid Reflux on Stromal Epithelial Interaction in Barrett's Esophagus
An observational study of Barrett's Esophagus, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to determine the association between acid reflux and cell changes in Barrett's esophagus. Specific aim 1: To test the hypothesis that controlled acid reflux is associated with lesser degree of stromal activation. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Barrett's Esophagus
- What is being tested?
- 24 hour pH study and upper endoscopy (EGD)
- Type of treatment
- Surgery or procedure
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Those diagnosed with barrett's esophagus confirmed by pathology with no dysplasia or low grade dysplasia
Who may be able to join
- Prior histological demonstration of Barrett's esophagus that is endoscopically visible; length of visible segment >/= 1 cm
- Absence of dysplasia or LGD on biopsies within the past 5 years
- Ability to provide informed consent
- Age between 18 years and 90 years at study entry.
Who cannot join
- Eastern Cooperative Oncology Group performance status 3 or 4
- Inability to tolerate endoscopic procedures
- Pregnancy: Females of child-bearing age will be screened with pregnancy test.
- Prior esophageal surgery, or cancer
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine the association between acid reflux and cell changes in Barrett's esophagus.
Specific aim 1: To test the hypothesis that controlled acid reflux is associated with lesser degree of stromal activation.
Specific aim 2: To test the hypothesis that stromal fibroblast derived growth factors drive BE epithelial proliferation.
- Conditions
- Barrett's Esophagus
- Being tested
- 24 hour pH study and upper endoscopy (EGD)
- Keywords
- Barrett's esophagus
- Medical subject headings
- Barrett Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
24 hour pH study and upper endoscopy (EGD)Procedure or surgery
All subjects enrolled will undergo 24 hour pH followed by EGD.
| Study group | Role | What they receive |
|---|---|---|
| Those with barrett's esophagus | Those with barrett's esophagus: no dysplasia or low grade dysplasia Receives: Procedure: 24 hour pH study and upper endoscopy (EGD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
activated myofibroblasts
The primary end point for the study will be the proportion of patients with activated myofibroblasts (defined as positive staining for SMA and vimentin with negative staining for Desmin, in > 50% of subepithelial myofibroblasts). This primary end point will be compared between the group with controlled acid reflux and the group without acid reflux.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2011 (estimated)
- Study startOct 2008
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Prasad G. Iyer, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01281618
- Sponsor's protocol ID
- 07-004899
- Acronym
- CR20
- Status last verified
- May 2013
- First submitted
- 20 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
- Influence of Acid Reflux on Stromal Epithelial Interaction in Barrett's Esophagus
- ClinicalTrials.gov ID
- NCT01281618
- Acronym / sponsor ID
- CR20 / 07-004899
- Conditions
- Barrett's Esophagus
- Keywords
- Barrett's esophagus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Oct 2008
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 24 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.
The purpose of this study is to determine the association between acid reflux and cell changes in Barrett's esophagus.
Specific aim 1: To test the hypothesis that controlled acid reflux is associated with lesser degree of stromal activation.
Specific aim 2: To test the hypothesis that stromal fibroblast derived growth factors drive BE epithelial proliferation.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Those with barrett's esophagus | – | Procedure: 24 hour pH study and upper endoscopy (EGD)Those with barrett's esophagus: no dysplasia or low grade dysplasia |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Those diagnosed with barrett's esophagus confirmed by pathology with no dysplasia or low grade dysplasia
Key inclusion criteria (4 listed)
- Prior histological demonstration of Barrett's esophagus that is endoscopically visible; length of visible segment >/= 1 cm
- Absence of dysplasia or LGD on biopsies within the past 5 years
- Ability to provide informed consent
- Age between 18 years and 90 years at study entry.
Key exclusion criteria (4 listed)
- Eastern Cooperative Oncology Group performance status 3 or 4
- Inability to tolerate endoscopic procedures
- Pregnancy: Females of child-bearing age will be screened with pregnancy test.
- Prior esophageal surgery, or cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 24 hour pH study and upper endoscopy (EGD)All subjects enrolled will undergo 24 hour pH followed by EGD. | Procedure or surgery | Those with barrett's esophagus |
Primary outcome
activated myofibroblasts
Time frame: 6 months
The primary end point for the study will be the proportion of patients with activated myofibroblasts (defined as positive staining for SMA and vimentin with negative staining for Desmin, in > 50% of subepithelial myofibroblasts). This primary end point will be compared between the group with controlled acid reflux and the group without acid reflux.
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, 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 4 inclusion and 4 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?
activated myofibroblasts (time frame: 6 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.