Detection of Barrett s Esophagus in Patients Without GERD Symptoms

Last updated: February 3, 2025
Sponsor: Case Comprehensive Cancer Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Barrett's Esophagus

Esophageal Disorders

Heartburn

Treatment

Esophago-gastro-duodenoscopy (EGD)

EsoCheck/EsoGuard (EC/EG)

Clinical Study ID

NCT04880044
CASE1221
  • Ages > 50
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 regurgitationwith 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 additionalrisk factors for BE (white race, central obesity defined as waist size >35 inchesfor women and >40 inches for men, male gender, current smoker or smoking history >10pack years, confirmed family history in at least two members with one being a firstdegree relative).

Exclusion

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 coagulopathywith international normalized ratio (INR) > 1.5

  • Known history of esophageal varices or esophageal stricture

  • Any contraindication, as deemed inInvestigator's medical judgment, to undergoing theEsoCheck procedure, undergoing the EGDprocedure,and/or having biopsies taken,including but not limited to due to comorbidities such as coagulopathy or a knownhistory 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 surgicalfundoplication procedure

  • History of myocardial infarction or cerebrovascular accident within past 6 months

Study Design

Total Participants: 500
Treatment Group(s): 2
Primary Treatment: Esophago-gastro-duodenoscopy (EGD)
Phase:
Study Start date:
January 05, 2022
Estimated Completion Date:
June 01, 2026

Study 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

Connect with a study center

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

    Cleveland, Ohio 44106-5065
    United States

    Active - Recruiting

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