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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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)) | 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. | Up to 2 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amitabh Chak, MD | University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center | Cleveland | Ohio | 44106-5065 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40748349 | Derived | 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. |
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All individual participant data (IPD) that result in publication
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| ID | Title | Description |
|---|---|---|
| FG000 | EC/EG & 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 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. Esophago-gastro-duodenoscopy (EGD): SOC diagnostic endoscopic procedure that visualizes the upper part of the gastrointestinal tract down to the duodenum. Tissue samples collected. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | EC/EG & 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 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. Esophago-gastro-duodenoscopy (EGD): SOC diagnostic endoscopic procedure that visualizes the upper part of the gastrointestinal tract down to the duodenum. Tissue samples collected. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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)) | Only participants who underwent EGD and meet criteria for PPV calculation were included. 83 participants were not included, as they did not meet these criteria. | Posted | Number | 95% Confidence Interval | Percentage of screened participants | Up to 2 months |
|
Up to 2 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | EC/EG & 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 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. Esophago-gastro-duodenoscopy (EGD): SOC diagnostic endoscopic procedure that visualizes the upper part of the gastrointestinal tract down to the duodenum. Tissue samples collected. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amitabh Chak, M.D., Principal Investigator | University Hospitals, Case Comprehensive Cancer Center | (216) 844-3217 | amitabh.chak@uhhospitals.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 14, 2023 | Feb 18, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 16, 2025 | Feb 18, 2026 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D001471 | Barrett Esophagus |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| 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. |
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Primary | 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. | Only participants who underwent EGD and meet criteria for NPV calculation were included. 92 participants were not included, as they did not meet these criteria. | Posted | Number | 95% Confidence Interval | Percentage of screened participants | Up to 2 months |
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| 0 |
| 132 |
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| 132 |
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| 132 |
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| D004066 |
| Digestive System Diseases |