Nonendoscopic Screening for Barrett's Esophagus in Veterans Without Chronic Reflux

NCT06746623 | Recruiting FDA Device

• 1 other identifier: DOD HT94252410741
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

The veteran population is at increased risk for EAC and its precursor lesion, Barrett's esophagus (BE), due to increased prevalence of disease risk factors compared to the general population. BE is traditionally diagnosed only when patients undergo endoscopy with biopsies. However, due to the high cost of endoscopy and the lack of studies proving efficacy of screening, endoscopy to screen for BE is not routinely recommended. A simpler screening procedure similar to a pap smear would be an ideal way to sample the esophageal tissue for cancer and its precursor condition, BE. This study proposes a non-endoscopic detection method administered in outpatient offices which would increase subsequent endoscopic detection of BE. The study team will be enrolling veterans who do not have history of gastroesophageal reflux but have multiple risk factors for esophageal adenocarcinoma.

Conditions

Obese Patients; Tobacco Use; Veterans; Family History of Esophageal Cancer; Barrett Esophagus

Keywords

Non-endoscopic screening; esophagus; Barrett

Outcome Measures

Primary Outcomes (1)

• Esoguard assay and histology confirming diagnosis of Barrett's esophagus and/or esophageal adenocarcinoma

  Results from enrollment visit

  Laboratory and pathology results will be finalized within 10 and up to 30 days

Study Arms (1)

This is a single arm study. Participants will complete 2 diagnostic tests: Esocheck and EGD.

OTHER

Patients without history of GERD receiving care in Wade Park VA will be approached regarding BE screening. Reasons for refusal of screening will be recorded. Adult subjects without history of gastroesophageal reflux with three or more risk factors- white race, male gender, obesity (BMI \> 30), smoking, or family history will be included. Only those patients who have not had prior EGD will be candidates for Esocheck screening. Distal esophageal samples will be assayed for mVIM + mCCNA1 (Esoguard assay). All patients will be offered upper endoscopy.

Diagnostic Test: Enrolled participants will complete Esocheck/Esoguard and diagnostic upper endoscopy.

Interventions

Enrolled participants will complete Esocheck/Esoguard and diagnostic upper endoscopy. DIAGNOSTIC_TEST

Esocheck (EC)/Esoguard (EG): EC is a encapsulated balloon device available commercially from Lucid Diagnostics (New York, NY). EG assay uses bisulfite sequencing for detection of aberrant methylation in the vimentin and cyclin A1 genomic loci, respectively. EGD (upper endoscopy): EGD will be performed by gastroenterologists practicing in the Louis Stokes Cleveland VA Medical Center Endoscopy laboratories on the same day when EC/EG is performed.

This is a single arm study. Participants will complete 2 diagnostic tests: Esocheck and EGD.

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients without history of chronic GERD who meet criteria for upper endoscopic screening for BE will be accrued35.
• Adults \> 40 and \< 85 years old who have no prior EGD and can provide informed consent
• Absence of chronic GERD symptoms (absence of weekly heartburn or regurgitation, not on medications for GERD), and are:
• a. Meet ACG/AGA Clinical Guideline criteria for BE screening. Eligible subjects will have at least three additional risk factors for BE (white race, obesity defined as BMI \> 30, male gender, current smoker or smoking history \> 10 pack years, family history of Barrett's esophagus or EAC central obesity (waist size \> 35 inches for women and \> 40 inches for men), white race, male sex, confirmed history of BE/EAC in at least two family members, with one a first degree relative).
• No known coagulopathy, no known esophageal varices, not on chronic anticoagulation therapy, and have:
• No significant dysphagia or odynophagia

You may not qualify if:

• History of prior EGD procedure in past ten years
• Inability to provide written informed consent
• History of weekly or 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
• History of difficulty swallowing (dysphagia) or painful swallowing (odynophagia), including swallowing pills
• Oropharyngeal tumor
• History of esophageal or gastric surgery, with exception on uncomplicated recent surgical fundoplication procedure with documented normal acid exposure time (AET) percent (AET \<4%)
• History of myocardial infarction or cerebrovascular accident within past 6 months

Sponsors & Collaborators

• Louis Stokes VA Medical Center: lead
• United States Department of Defense: collaborator

Study Sites (1)

VA Northeast Ohio Healthcare System

Cleveland, Ohio, 44106, United States

RECRUITING

Related Publications (1)

• Greer KB, Blum AE, Faulx AL, Deming EM, Hricik LL, Siddiqui H, Wilson BM, Chak A. Nonendoscopic Screening for Barrett's Esophagus and Esophageal Adenocarcinoma in At-Risk Veterans. Am J Gastroenterol. 2025 Mar 1;120(3):545-553. doi: 10.14309/ajg.0000000000002962. Epub 2024 Jul 11.

  PMID: 38989889 BACKGROUND

MeSH Terms

Conditions

Tobacco Use; Barrett Esophagus

Condition Hierarchy (Ancestors)

Behavior; Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Katarina B Greer, MD/MS

  Cleveland VA Research and Education Foundation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katarina B. Greer, MD/MS

CONTACT

216-791-3800; katarina.greer@va.gov

Lauren H. Hricik, BA

CONTACT

(216) 791-3800; lauren.hricik@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Participants will complete screening for the condition by completing bedside Esocheck test and upper endoscopy. Providers performing endoscopy will not have result of Esocheck test available to them when performing upper endoscopy. Lab analysis team will not have endoscopy and histology results available to them to interpret methylation status results or Esoguard assay.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Gastroenterologist, Associate Professor of Medicine

Study Record Dates

• First Submitted: November 15, 2024
• First Posted: December 24, 2024
• Study Start: April 11, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: June 5, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Study protocol, statistical analysis plan and informed consent will be made available upon request from principal investigator. Study report will be available at the end of study period, i.e. in September of 2027.

Locations

US (1)