Barrett EsophagusNCT06687603
Multi-Site Detection of Barrett's Esophagus in Patients Without Chronic GERD Symptoms
A study testing EsoCheck and EsoGuard in people with Barrett Esophagus and Gastroesophageal Reflux, run by Case Comprehensive Cancer Center at 5 sites in United States.
Trial summary
The goal of this clinical trial is to develop a method to detect Barrett's esophagus in individuals with a new office based diagnostic test. Barrett's esophagus is a condition in which the flat pink lining of the swallowing tube that connects the mouth to the stomach (the esophagus) becomes damaged by acid reflux. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Barrett Esophagus, Gastroesophageal Reflux, Esophageal Adenocarcinoma
- What is being tested?
- EsoCheck and EsoGuard
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 5 sitesUnited States
- Study dates
- 10 Mar 2025to 27 Sep 2029
- Phase
- Interventional
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients undergoing screening colonoscopy are an accessible cohort for BE screening and are also a reasonable representation of the general population. Permission will be obtained from colonoscopy physicians for researchers to contact and recruit patients for this study. Patients without GERD, who are at risk for BE, and who have not had a prior EGD, will be recruited prior to or at the time of scheduled colonoscopy.(9) Those eligible will be:
- Adults who have not had prior EGD within past ten years, and are able to provide informed consent, and who have:
- No known coagulopathy, no known esophageal varices, not on chronic anticoagulation therapy, and have:
- No significant dysphagia or odynophagia; but who do have:
- Absence of GERD (absence of weekly heartburn or regurgitation, not on medications for GERD), and are:
- Adults > age 50, who also have two or more added risk factors for BE from the set of: central obesity (waist size > 35 inches for women and > 40 inches for men), current smoker or smoking history > 10 pack years, white race, male sex, confirmed history of BE/EAC in at least two family members, with one a first degree relative. While BE is most highly prevalent in white males, a black female over age 50 with obesity and a positive smoking history would also be at increased BE risk and would equally meet eligibility criteria.
- Subjects must have the ability to understand and the willingness to sign a written informed consent document.
- Subjects must have the ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- History of prior EGD procedure in past ten years
- 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 INR > 1.5
- Known history of esophageal varices or esophageal stricture
- Any contraindication, as deemed in Investigator's medical judgment, to undergoing the EsoCheck procedure, undergoing the EGD procedure, 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
Show all 9Show fewer
- History of difficulty swallowing (dysphagia) or painful swallowing (odynophagia), including swallowing pills
- Oropharyngeal tumor
- History of esophageal or gastric surgery, with exception of uncomplicated surgical fundoplication procedure
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
University of Colorado
Aurora, Colorado, 80045
Sachin Wani, MD
Sachin Wani, MD
- Recruiting
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Marcia Canto, MD
Marcia Canto, MD
- Recruiting
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 027599
Nicholas Shaheen, MD
Nicholas Shaheen, MD
- Recruiting
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44016
Amitabh Chak, MD
Amitabh.Chak@UHHospitals.org
- Recruiting
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
Prashanti Thota, MD
Prashanti Thota, MD
About this study
The goal of this clinical trial is to develop a method to detect Barrett's esophagus in individuals with a new office based diagnostic test. Barrett's esophagus is a condition in which the flat pink lining of the swallowing tube that connects the mouth to the stomach (the esophagus) becomes damaged by acid reflux. The main question it aims to answer is: Can this approach demonstrate efficacy for screening of Barrett's esophagus?
Participants will:
- Participate in a questionnaire.
- Undergo a capsule balloon test, called EsoCheck.
- Have their EsoCheck sample sent to the laboratory for an EsoGuard test, which is used to detect Barrett's esophagus.
- Participants will undergo upper endoscopy as part of standard of care.
Read the detailed description
The overall goal of this clinical trial is to eliminate deaths from Esophageal Adenocarcinoma (EAC) by demonstrating the efficacy of a non-endoscopic method for efficient population screening to detect all Barrett's esophagus (BE), the precursor lesion of EAC. EAC is a highly lethal malignancy with less than 20% 5-year survival, and an annual U.S. incidence > 14,000 that has increased more than 6-fold in the past three decades. Barrett's esophagus, a pre-malignant metaplasia/neoplasia, is the precursor lesion of EAC, but is currently detectable only when patients undergo upper endoscopy (EGD). Despite Guideline recommendations for EGD in chronic GERD (gastrointestinal reflux disease) patients, barriers to EGD that include cost, sedation, and lack of acceptance, have so severely limited screening that antecedent BE remains undetected in over 95% of EAC cases. A major advance in EAC prevention was made by developing a non- endoscopic biomarker based method for detecting BE. The technology consists of an encapsulated swallowable balloon (EsoCheck) enabling a 5 minute non-endoscopic sampling of the esophagus, combined with a methylated DNA panel that detects esophageal neoplasia (EsoGuard). The research team validated the > 90% sensitivity and specificity of EC+EG testing in the population of individuals who have symptomatic GERD, and who account for 60% of EAC cases. In this new proposal, the research team plans to double the impact of this technology to detect nearly all individuals harboring BE, by proving the EC+EG technology is so robust that it further enables screening a population of high risk, but asymptomatic, non-GERD individuals who account for the remaining 40% of EAC cases, but who fall totally outside of all current screening guidelines.
- Being tested
- EsoCheck, EsoGuard
- Keywords
- Esophagus, Non-endoscopic
- Medical subject headings
- Barrett Esophagus, Gastroesophageal Reflux, Adenocarcinoma Of Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsoCheckDevice
FDA-approved, non-endoscopic, encapsulated swallowable balloon. EsoCheck will produce a sample which will subsequently be tested with EsoGuard assay. The EsoCheck is performed and completed in approximately 5 minutes.
EsoGuardDiagnostic test
Approved laboratory, methylated DNA panel that detects esophageal neoplasia. The EsoGuard assay tests the EsoCheck samples to detect BE in GERD participants.
| Study group | Role | What they receive |
|---|---|---|
| EsoCheck + EsoGuard | Experimental | Participants will undergo an EsoCheck test. The sample produced by the EsoCheck will be sent to LucidDx where the EsoGuard assay will be performed. Receives: Device: EsoCheck; Diagnostic Test: EsoGuard |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive predictive value for Barret's Esophagus in EsoCheck/EsoGuard positive participants
The primary goal of this study is to develop a non-endoscopic screening test for the non-GERD population that provides a PPV >20%, i.e. at least 2-fold greater than the 10% PPV of society recommended EGD screening of chronic GERD patients with any additional risk factors.
Measured: Up to 5 years
Barrett's Esophagus prevalence in EsoCheck/EsoGuard test negative subjects from a high-risk GERD negative population
This study will also perform endoscopy in a sample of EC/EG negative subjects to confirm that BE is enriched in the test positive versus test negative population. This will be measured by the prevalence of BE in a high-risk GERD negative population.
Measured: Up to 5 years
Tissue origins of true positive versus false positive EsoCheck/EsoGuard tests in non-GERD screening population
In BE positive cases, biopsies will be taken every 2-cm across the BE segment to map the extent of the field of methylated Vimentin (mVim) and methylated CCNA1 (mCCNA1) DNA detected by EsoGuard.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2024
- Study start10 Mar 2025
- Primary completion27 Sep 2028 (estimated)
- Study completion27 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Barrett 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 800 participants (estimated)
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
- NCT06687603
- Sponsor's protocol ID
- CASE10224
- Status last verified
- Sep 2026
- First submitted
- 12 Nov 2024
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Site Detection of Barrett's Esophagus in Patients Without Chronic GERD Symptoms
- ClinicalTrials.gov ID
- NCT06687603
- Acronym / sponsor ID
- CASE10224
- Keywords
- Esophagus, Non-endoscopic
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 10 Mar 2025 (actual)
- Primary completion
- 27 Sep 2028 (estimated)
- Study completion
- 27 Sep 2029 (estimated)
- First posted
- 13 Nov 2024 (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 goal of this clinical trial is to develop a method to detect Barrett's esophagus in individuals with a new office based diagnostic test. Barrett's esophagus is a condition in which the flat pink lining of the swallowing tube that connects the mouth to the stomach (the esophagus) becomes damaged by acid reflux. The main question it aims to answer is: Can this approach demonstrate efficacy for screening of Barrett's esophagus?
Participants will:
- Participate in a questionnaire.
- Undergo a capsule balloon test, called EsoCheck.
- Have their EsoCheck sample sent to the laboratory for an EsoGuard test, which is used to detect Barrett's esophagus.
- Participants will undergo upper endoscopy as part of standard of care.
Detailed description
The overall goal of this clinical trial is to eliminate deaths from Esophageal Adenocarcinoma (EAC) by demonstrating the efficacy of a non-endoscopic method for efficient population screening to detect all Barrett's esophagus (BE), the precursor lesion of EAC. EAC is a highly lethal malignancy with less than 20% 5-year survival, and an annual U.S. incidence > 14,000 that has increased more than 6-fold in the past three decades. Barrett's esophagus, a pre-malignant metaplasia/neoplasia, is the precursor lesion of EAC, but is currently detectable only when patients undergo upper endoscopy (EGD). Despite Guideline recommendations for EGD in chronic GERD (gastrointestinal reflux disease) patients, barriers to EGD that include cost, sedation, and lack of acceptance, have so severely limited screening that antecedent BE remains undetected in over 95% of EAC cases. A major advance in EAC prevention was made by developing a non- endoscopic biomarker based method for detecting BE. The technology consists of an encapsulated swallowable balloon (EsoCheck) enabling a 5 minute non-endoscopic sampling of the esophagus, combined with a methylated DNA panel that detects esophageal neoplasia (EsoGuard). The research team validated the > 90% sensitivity and specificity of EC+EG testing in the population of individuals who have symptomatic GERD, and who account for 60% of EAC cases. In this new proposal, the research team plans to double the impact of this technology to detect nearly all individuals harboring BE, by proving the EC+EG technology is so robust that it further enables screening a population of high risk, but asymptomatic, non-GERD individuals who account for the remaining 40% of EAC cases, but who fall totally outside of all current screening guidelines.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EsoCheck + EsoGuard | Experimental | Device: EsoCheck, Diagnostic Test: EsoGuardParticipants will undergo an EsoCheck test. The sample produced by the EsoCheck will be sent to LucidDx where the EsoGuard assay will be performed. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients undergoing screening colonoscopy are an accessible cohort for BE screening and are also a reasonable representation of the general population. Permission will be obtained from colonoscopy physicians for researchers to contact and recruit patients for this study. Patients without GERD, who are at risk for BE, and who have not had a prior EGD, will be recruited prior to or at the time of scheduled colonoscopy.(9) Those eligible will be:
- Adults who have not had prior EGD within past ten years, and are able to provide informed consent, and who have:
- No known coagulopathy, no known esophageal varices, not on chronic anticoagulation therapy, and have:
- No significant dysphagia or odynophagia; but who do have:
- Absence of GERD (absence of weekly heartburn or regurgitation, not on medications for GERD), and are:
Key exclusion criteria (9 listed)
- History of prior EGD procedure in past ten years
- 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 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 |
|---|---|---|
| EsoCheckFDA-approved, non-endoscopic, encapsulated swallowable balloon. EsoCheck will produce a sample which will subsequently be tested with EsoGuard assay. The EsoCheck is performed and completed in approximately 5 minutes. | Device | EsoCheck + EsoGuard |
| EsoGuardApproved laboratory, methylated DNA panel that detects esophageal neoplasia. The EsoGuard assay tests the EsoCheck samples to detect BE in GERD participants. | Diagnostic test | EsoCheck + EsoGuard |
Primary outcome
Positive predictive value for Barret's Esophagus in EsoCheck/EsoGuard positive participants
Time frame: Up to 5 years
The primary goal of this study is to develop a non-endoscopic screening test for the non-GERD population that provides a PPV >20%, i.e. at least 2-fold greater than the 10% PPV of society recommended EGD screening of chronic GERD patients with any additional risk factors.
Barrett's Esophagus prevalence in EsoCheck/EsoGuard test negative subjects from a high-risk GERD negative population
Time frame: Up to 5 years
This study will also perform endoscopy in a sample of EC/EG negative subjects to confirm that BE is enriched in the test positive versus test negative population. This will be measured by the prevalence of BE in a high-risk GERD negative population.
Tissue origins of true positive versus false positive EsoCheck/EsoGuard tests in non-GERD screening population
Time frame: Up to 5 years
In BE positive cases, biopsies will be taken every 2-cm across the BE segment to map the extent of the field of methylated Vimentin (mVim) and methylated CCNA1 (mCCNA1) DNA detected by EsoGuard.
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 15 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Barrett Esophagus
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"Less-is-more in Barrett-surveillance" Care Evaluation of Barrett's Patients With Low-Risk in Whom Endoscopic Surveillance is Stopped. The BLISS Project.
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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.
Amitabh Chak, MD principal investigator
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EsoCheck and EsoGuard in people with Barrett Esophagus and Gastroesophageal Reflux, run by Case Comprehensive Cancer Center at 5 sites 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 8 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Contact Wendy Brock (216-844-3853, Wendy.brock@uhhospitals.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive predictive value for Barret's Esophagus in EsoCheck/EsoGuard positive participants (time frame: Up to 5 years). The study lists 3 primary outcomes in all. 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 15 Sep 2026.