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

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Louis Stokes VA Medical Center
Study ID
NCT06746623
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
40 Years - 85 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Apr 11, 2025
Status verified
Apr 2025
Primary completion
Dec 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
400 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

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.

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

Locations (1)

FacilityCityStateZIPSite coordinators
VA Northeast Ohio Healthcare SystemClevelandOhio44106
Neal Associate Chief of Staff- Research
[email protected]
216-791-3800

Find similar trials in Cleveland, OH

By research site
VA Northeast Ohio Healthcare System· Cleveland, OH

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