Detection of Barrett s Esophagus in Patients Without GERD Symptoms

NCT ID: NCT04880044

Last Updated: 2025-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 132 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-05
• Study Completion Date: 2025-02-25

Brief 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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

EsoCheck/EsoGuard (EC/EG)

Intervention Type: 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)

Intervention Type: DIAGNOSTIC_TEST

SOC diagnostic endoscopic procedure that visualizes the upper part of the gastrointestinal tract down to the duodenum. Tissue samples collected.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Esophago-gastro-duodenoscopy (EGD)

SOC diagnostic endoscopic procedure that visualizes the upper part of the gastrointestinal tract down to the duodenum. Tissue samples collected.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• 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).

Exclusion Criteria

• 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
• 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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Case Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amitabh Chak, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Locations

University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Countries

United States

References

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. 2025 Aug 1. doi: 10.14309/ajg.0000000000003669. Online ahead of print.

Reference Type: DERIVED

PMID: 40748349 (View on PubMed)

Other Identifiers

CASE1221

Identifier Type: -

Identifier Source: org_study_id