Barrett's EsophagusNCT04880044
Detection of Barrett s Esophagus in Patients Without GERD Symptoms
A study testing EsoCheck/EsoGuard (EC/EG) and Esophago-gastro-duodenoscopy (EGD) in people with Barrett's Esophagus, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to develop a method to detect Barrett's esophagus (BE) in individuals with a new office-based diagnostic test. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Barrett's Esophagus
- What is being tested?
- EsoCheck/EsoGuard (EC/EG) and Esophago-gastro-duodenoscopy (EGD)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jan 2022to 25 Feb 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- No known coagulopathy, no known esophageal varices.
- No significant dysphagia or odynophagia
- Absence of chronic GERD, defined as five or more years of heartburn or regurgitation with symptoms at least once a week when not on medications for GERD symptoms.
- Subjects to qualify must meet criterion 3, be over age 50, and have two additional risk factors for BE (white race, central obesity defined as waist size >35 inches for women and >40 inches for men, male gender, current smoker or smoking history >10 pack years, confirmed family history in at least two members with one being a first degree relative).
Who cannot join
- History of prior EGD procedure
- Inability to provide written informed consent
- History of weekly of more frequent heartburn or regurgitation for five or more years
- On anti-coagulant drug(s)that cannot be temporarily discontinued or coagulopathy with international normalized ratio (INR) > 1.5
- Known history of esophageal varices or esophageal stricture
- Any contraindication, as deemed inInvestigator's medical judgment, to undergoing the EsoCheck procedure, undergoing the EGDprocedure,and/or having biopsies taken, including but not limited to due to comorbidities such as coagulopathy or a known history of esophageal diverticula, esophageal fistula and/or esophageal ulceration
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- History of difficulty swallowing (dysphagia) or painful swallowing (odynophagia), including swallowing pills
- Oropharyngeal tumor
- History of esophageal or gastric surgery, with exception on uncomplicated surgical fundoplication procedure
- History of myocardial infarction or cerebrovascular accident within past 6 months
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106-5065
About this study
Official title: Detection of Barrett s Esophagus in Patients Without Gastroesophageal Reflux Disease (GERD) Symptoms
The purpose of this study is to develop a method to detect Barrett's esophagus (BE) in individuals with a new office-based diagnostic test.
Read the detailed description
This study will investigate whether using EsoCheck/EsoGuard(EC/EG) can detect BE in individuals at risk for BE who are currently not being detected and are not undergoing routine esophago-gastro-duodenoscopy (EGD)
BE can only be diagnosed by performing upper endoscopy. Up to 500 adults who have risk factors for BE but do not have chronic heartburn or regurgitation will be enrolled in this study. This will include the EsoCheck/EsoGuard determination along with the upper endoscopy for qualifying EsoGuard negative subjects
- Conditions
- Barrett's Esophagus
- Being tested
- EsoCheck/EsoGuard (EC/EG), Esophago-gastro-duodenoscopy (EGD)
- Medical subject headings
- Barrett Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsoCheck/EsoGuard (EC/EG)Diagnostic test
EC is a swallowed capsule on a tethered catheter that obtains a touch sample of the distal esophagus. The obtained sample is placed in a buffer and sent to a diagnostics lab for testing of methylated markers from extracted DNA. EG is a methylated DNA test . A positive EG is associated with Barrett's esophagus at all its stages.
Esophago-gastro-duodenoscopy (EGD)Diagnostic test
SOC diagnostic endoscopic procedure that visualizes the upper part of the gastrointestinal tract down to the duodenum. Tissue samples collected.
| Study group | Role | What they receive |
|---|---|---|
| EC/EG & EGD | Experimental | Participants will complete a study questionnaire about reflux symptoms. Performance of an EsoCheck (EC) procedure; the EC sample will subsequently be tested with the EsoGuard (EG) assay
If EG assay results come back positive, participant is requested to complete standard of care (SOC) upper endoscopy (tissue samples collected)
If EG assay results come back negative, selected participants (100 volunteers) will also undergo a research EGD if they consent Receives: Diagnostic Test: EsoCheck/EsoGuard (EC/EG); Diagnostic Test: Esophago-gastro-duodenoscopy (EGD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive Predictive Value (PPV) of EC/EG in a Non-GERD Population That Has Three or More Non-GERD Risk Factors for BE.
PPV of EC/EG in a non-GERD population that has three or more non-GERD risk factors for BE. Participants who are at risk will be offered EC/EG. Those who are positive will undergo subsequent EGD
PPV = (EC/EG positive \& EGD positive) / ((EC/EG positive \& EGD positive) + (EC/EG positive \& EGD negative))
Measured: Up to 2 months
Proportion of Participants Negative Via EC/EG Who Subsequently Are Proven Negative Via EGD
Negative Predictive Value (NPV):
Proportion of participants negative via EC/EG who subsequently are proven negative via EGD. This will be measured by offering EGD to a proportion of patients who are EC/EG negative.
Measured: Up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2021
- Study start5 Jan 2022
- Primary completion25 Feb 2025
- Study completion25 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Barrett's EsophagusStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amitabh Chak, MD, Principal investigator, University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04880044
- Sponsor's protocol ID
- CASE1221
- Status last verified
- Feb 2026
- First submitted
- 5 May 2021
- Last updated
- 10 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: All individual participant data (IPD) that result in publication
Publications
Chak A, Keerthy K, Wang GM, Brock W, Bednarchik B, Guptha R, Verma S, Moinova H, Tatsuoka C, Dumot J, Thomas S, Willis JE, Markowitz S. Nonendoscopic Detection of Barrett's Esophagus on Patients Without Gastroesophageal Reflux Disease Symptoms. Am J Gastroenterol. 2026 Jan 1;121(1):258-261. doi: 10.14309/ajg.0000000000003669. Epub 2025 Aug 1.
PubMed 40748349
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Barrett s Esophagus in Patients Without Gastroesophageal Reflux Disease (GERD) Symptoms
- ClinicalTrials.gov ID
- NCT04880044
- Acronym / sponsor ID
- CASE1221
- Conditions
- Barrett's Esophagus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 5 Jan 2022 (actual)
- Primary completion
- 25 Feb 2025 (actual)
- Study completion
- 25 Feb 2025 (actual)
- First posted
- 10 May 2021 (actual)
- Results
- Posted 10 Mar 2026
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 develop a method to detect Barrett's esophagus (BE) in individuals with a new office-based diagnostic test.
Detailed description
This study will investigate whether using EsoCheck/EsoGuard(EC/EG) can detect BE in individuals at risk for BE who are currently not being detected and are not undergoing routine esophago-gastro-duodenoscopy (EGD)
BE can only be diagnosed by performing upper endoscopy. Up to 500 adults who have risk factors for BE but do not have chronic heartburn or regurgitation will be enrolled in this study. This will include the EsoCheck/EsoGuard determination along with the upper endoscopy for qualifying EsoGuard negative subjects
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EC/EG & EGD | Experimental | Diagnostic Test: EsoCheck/EsoGuard (EC/EG), Diagnostic Test: Esophago-gastro-duodenoscopy (EGD)Participants will complete a study questionnaire about reflux symptoms. Performance of an EsoCheck (EC) procedure; the EC sample will subsequently be tested with the EsoGuard (EG) assay If EG assay results come back positive, participant is requested to complete standard of care (SOC) upper endoscopy (tissue samples collected) If EG assay results come back negative, selected participants (100 volunteers) will also undergo a research EGD if they consent |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- No known coagulopathy, no known esophageal varices.
- No significant dysphagia or odynophagia
- Absence of chronic GERD, defined as five or more years of heartburn or regurgitation with symptoms at least once a week when not on medications for GERD symptoms.
- Subjects to qualify must meet criterion 3, be over age 50, and have two additional risk factors for BE (white race, central obesity defined as waist size >35 inches for women and >40 inches for men, male gender, current smoker or smoking history >10 pack years, confirmed family history in at least two members with one being a first degree relative).
Key exclusion criteria (10 listed)
- History of prior EGD procedure
- Inability to provide written informed consent
- History of weekly of more frequent heartburn or regurgitation for five or more years
- On anti-coagulant drug(s)that cannot be temporarily discontinued or coagulopathy with international normalized ratio (INR) > 1.5
- Known history of esophageal varices or esophageal stricture
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 |
|---|---|---|
| EsoCheck/EsoGuard (EC/EG)EC is a swallowed capsule on a tethered catheter that obtains a touch sample of the distal esophagus. The obtained sample is placed in a buffer and sent to a diagnostics lab for testing of methylated markers from extracted DNA. EG is a methylated DNA test . A positive EG is associated with Barrett's esophagus at all its stages. | Diagnostic test | EC/EG & EGD |
| Esophago-gastro-duodenoscopy (EGD)SOC diagnostic endoscopic procedure that visualizes the upper part of the gastrointestinal tract down to the duodenum. Tissue samples collected. | Diagnostic test | EC/EG & EGD |
Primary outcome
Positive Predictive Value (PPV) of EC/EG in a Non-GERD Population That Has Three or More Non-GERD Risk Factors for BE.
Time frame: Up to 2 months
PPV of EC/EG in a non-GERD population that has three or more non-GERD risk factors for BE. Participants who are at risk will be offered EC/EG. Those who are positive will undergo subsequent EGD PPV = (EC/EG positive \& EGD positive) / ((EC/EG positive \& EGD positive) + (EC/EG positive \& EGD negative))
Proportion of Participants Negative Via EC/EG Who Subsequently Are Proven Negative Via EGD
Time frame: Up to 2 months
Negative Predictive Value (NPV): Proportion of participants negative via EC/EG who subsequently are proven negative via EGD. This will be measured by offering EGD to a proportion of patients who are EC/EG negative.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40748349Chak A, Keerthy K, Wang GM, Brock W, Bednarchik B, Guptha R, Verma S, Moinova H, Tatsuoka C, Dumot J, Thomas S, Willis JE, Markowitz S. Nonendoscopic Detection of Barrett's Esophagus on Patients Without Gastroesophageal Reflux Disease Symptoms. Am J Gastroenterol. 2026 Jan 1;121(1):258-261. doi: 10.14309/ajg.0000000000003669. Epub 2025 Aug 1.
- Individual participant dataSharing planned: Yes. All individual participant data (IPD) that result in publication
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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.
Amitabh Chak, MD principal investigator
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EsoCheck/EsoGuard (EC/EG) and Esophago-gastro-duodenoscopy (EGD) in people with Barrett's Esophagus, run by Case Comprehensive Cancer Center 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 10 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 10 Mar 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?
Yes. Results are posted in the registry (first posted 10 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Positive Predictive Value (PPV) of EC/EG in a Non-GERD Population That Has Three or More Non-GERD Risk Factors for BE. (time frame: Up to 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04880044, which also lists 1 linked publication.
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 10 Mar 2026.