Recruiting

Observational Study

Sponsor:

Cleveland VA Medical Research and Education Foundation

Code:

NCT05210049

Conditions

Barrett Esophagus

GERD

Obesity

Esophageal Cancer

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

Esocheck/Esoguard

Study Details

Brief summary:

This study seeks to incorporate non-endoscopic detection method (Esocheck/Esoguard) in primary care practice and test whether this screening modality increases the positive predictive value of upper endoscopy and increases the detection of Barrett's esophagus and esophageal cancer.

Conditions

Barrett Esophagus

GERD

Obesity

Esophageal Cancer

Study ID

NCT05210049

Start date

Mar 1, 2022

Status verified date

Dec, 2022

Completion date

Aug 31, 2024

Anticipated

Primary completion date

Aug 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Patients who have symptomatic GERD and also meet criteria for upper endoscopic screening for BE will be accrued. Eligible patients will include:

1. Adult Veterans > 40 and < 85 years old who have no prior EGD and can provide informed consent
2. No known coagulopathy, no known esophageal varices.
3. No significant dysphagia or odynophagia
4. Documented GERD or use of proton pump inhibitors (PPIs) for > 5 years
5. Meet ACG Clinical Guideline criteria for BE screening (that require presence of multiple risk factors 21). Eligible subjects to qualify must have will have GERD plus at least two additional risk factors for BE (white race, obesity defined as BMI > 30, male gender, smoking history, family history).

Exclusion Criteria:

1. Patients with known coagulopathy (INR > 1.5) will be excluded
2. Patients with known esophageal varices will be excluded.
3. Patients with significant dysphagia (unable to swallow solids) or odynophagia will be excluded

Study Design

Enrollment

125 participants

Anticipated

Intervention Model

Single group

Primary purpose

Screening

Interventions and Outcome Measures

Arms

other: Patients undergoing routine screening via upper endoscopy (EGD)

All enrolled patients will complete upper endoscopy for screening for Barrett's esophagus and esophageal adenocarcinoma.

Interventions

Esocheck/Esoguard

All enrolled patients will complete the Esocheck screening test. EsoCheck is a cell collection device that is designed to collect cells of a targeted region of the esophagus. The collected cell material is examined with a two marker panel combining methylated CCNA1 and VIM. These methylated markers have 95% sensitivity and 91% specificity for detecting BE and EAC with an AUC=0.95 in studies performed among white men. Diagnostic yield of this test among Veterans is unknown.

Primary outcome measure

  • Sensitivity and Specificity of Esocheck/Esoguard in a Veteran population [ Time Frame: Through study completion, up to 2.5 years ]

Central Contacts and Locations

Central contacts

Locations

Louis Stokes Cleveland VA Medical Center

Recruiting

Cleveland, Ohio, United States, 44016

Contacts

More Information

Sponsor

Cleveland VA Medical Research and Education Foundation

Last update posted

Dec 15, 2022

Last verified

Dec, 2022

Keywords

  • Barrett Esophagus
  • Screening

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 2022-12-15.