Barrett's Esophagus Without DysplasiaNCT03316053
Cell Marker Predictors in Barrett's Esophagus
An observational study of Barrett's Esophagus Without Dysplasia, run by The Guthrie Clinic at 1 site in United States.
Trial summary
The purpose of this study is to analyze biopsied tissue samples for changes in cells and genes involved in Barrett's Esophagus. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Barrett's Esophagus Without Dysplasia
- What is being tested?
- Tissue sample for genetic testing
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2017to 1 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a history of Barrett's esophagus
Who may be able to join
- History of Barrett's esophagus; scheduled for routine upper endoscopy
Who cannot join
- Under 18 years of age
- Unable to consent on own behalf
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to analyze biopsied tissue samples for changes in cells and genes involved in Barrett's Esophagus.
Read the detailed description
Patients with a history of Barrett's esophagus who are scheduled for a routine endoscopy will have an additional biopsy taken for genetic testing.
- Conditions
- Barrett's Esophagus Without Dysplasia
- Being tested
- Tissue sample for genetic testing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tissue sample for genetic testingOther
Tissue sample to be obtained during routine endoscopy
| Study group | Role | What they receive |
|---|---|---|
| Tissue Sample for genetic testing | Biopsy sample Receives: Other: Tissue sample for genetic testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cell Markers
Identify genes involved in Barrett's Esophagus
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2017
- Study start15 Nov 2017
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Barrett's Esophagus Without DysplasiaStudies of the same condition, open and under way.
- 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
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Guthrie Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Georgetson, MD, Principal investigator, The Guthrie Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03316053
- Sponsor's protocol ID
- 1708-43
- Status last verified
- Jan 2026
- First submitted
- 16 Oct 2017
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cell Marker Predictors in Barrett's Esophagus
- ClinicalTrials.gov ID
- NCT03316053
- Acronym / sponsor ID
- 1708-43
- Conditions
- Barrett's Esophagus Without Dysplasia
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- The Guthrie ClinicUniversity, hospital or other
- Study start
- 15 Nov 2017 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 20 Oct 2017 (actual)
- 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 analyze biopsied tissue samples for changes in cells and genes involved in Barrett's Esophagus.
Detailed description
Patients with a history of Barrett's esophagus who are scheduled for a routine endoscopy will have an additional biopsy taken for genetic testing.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tissue Sample for genetic testing | – | Other: Tissue sample for genetic testingBiopsy sample |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a history of Barrett's esophagus
Key inclusion criteria (1 listed)
- History of Barrett's esophagus; scheduled for routine upper endoscopy
Key exclusion criteria (2 listed)
- Under 18 years of age
- Unable to consent on own behalf
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 |
|---|---|---|
| Tissue sample for genetic testingTissue sample to be obtained during routine endoscopy | Other | Tissue Sample for genetic testing |
Primary outcome
Cell Markers
Time frame: through study completion, an average of 1 year
Identify genes involved in Barrett's Esophagus
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Individual participant dataSharing planned: No
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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.
Michael Georgetson, MD principal investigator
The Guthrie Clinic
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 Without Dysplasia, run by The Guthrie 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 1 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 7 Jan 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Cell Markers (time frame: through study completion, an average of 1 year). 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 7 Jan 2026.