Recruiting

Non-Endoscopic Detection

Sponsor:

Cleveland VA Medical Research and Education Foundation

Code:

NCT06746623

Conditions

Obese Patients

Tobacco Use

Veterans

Family History of Esophageal Cancer

Barrett Esophagus

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

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

Study Details

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

Study ID

NCT06746623

Start date

Apr 11, 2025

Status verified date

Apr, 2025

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients without history of chronic GERD who meet criteria for upper endoscopic screening for BE will be accrued35.

1. Adults > 40 and < 85 years old who have no prior EGD and can provide informed consent
2. 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).
3. No known coagulopathy, no known esophageal varices, not on chronic anticoagulation therapy, and have:
4. No significant dysphagia or odynophagia

Exclusion Criteria:

  • Exclusion Criteria

1. History of prior EGD procedure in past ten years
2. Inability to provide written informed consent
3. History of weekly or more frequent heartburn or regurgitation for five or more years
4. On anti-coagulant drug(s) that cannot be temporarily discontinued or coagulopathy with INR > 1.5
5. Known history of esophageal varices or esophageal stricture
6. 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
7. History of difficulty swallowing (dysphagia) or painful swallowing (odynophagia), including swallowing pills
8. Oropharyngeal tumor
9. History of esophageal or gastric surgery, with exception on uncomplicated recent surgical fundoplication procedure with documented normal acid exposure time (AET) percent (AET <4%)
10. History of myocardial infarction or cerebrovascular accident within past 6 months

Study Design

Enrollment

400 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

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

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.

Interventions

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

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.

Primary outcome measure

  • Esoguard assay and histology confirming diagnosis of Barrett's esophagus and/or esophageal adenocarcinoma [ Time Frame: Laboratory and pathology results will be finalized within 10 and up to 30 days ]

Central Contacts and Locations

Central contacts

Locations

VA Northeast Ohio Healthcare System

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Neal Associate Chief of Staff- Research

216-791-3800neal.peachy@va.gov

More Information

Sponsor

Cleveland VA Medical Research and Education Foundation

Last update posted

Jun 5, 2025

Last verified

Apr, 2025

Keywords

  • Non-endoscopic screening
  • esophagus
  • Barrett

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Cleveland VA Medical Research and Education Foundation on 2025-06-05.