Detecting Barrett's Esophagus in Patients Without GERD Symptoms

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to develop a non-endoscopic method for detecting Barrett's esophagus in individuals who do not exhibit chronic GERD symptoms. Participants will complete a questionnaire, undergo a capsule balloon test called EsoCheck, and have their samples analyzed using the EsoGuard test to identify Barrett's esophagus. The study seeks to address the high incidence of esophageal adenocarcinoma by improving screening methods, as current detection relies heavily on upper endoscopy, which is underutilized. The trial will recruit patients undergoing screening colonoscopy to evaluate the efficacy of this new diagnostic approach.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Patients undergoing screening colonoscopy are an accessible cohort for BE screening and are also a reasonable representation of the general population. Permission will be obtained from colonoscopy physicians for researchers to contact and recruit patients for this study. Patients without GERD, who are at risk for BE, and who have not had a prior EGD, will be recruited prior to or at the time of scheduled colonoscopy.(9) Those eligible will be:

* Adults who have not had prior EGD within past ten years, and are able to provide informed consent, and who have:
* No known coagulopathy, no known esophageal varices, not on chronic anticoagulation therapy, and have:
* No significant dysphagia or odynophagia; but who do have:
* Absence of GERD (absence of weekly heartburn or regurgitation, not on medications for GERD), and are:
* Adults \> age 50, who also have two or more added risk factors for BE from the set of: central obesity (waist size \> 35 inches for women and \> 40 inches for men), current smoker or smoking history \> 10 pack years, white race, male sex, confirmed history of BE/EAC in at least two family members, with one a first degree relative. While BE is most highly prevalent in white males, a black female over age 50 with obesity and a positive smoking history would also be at increased BE risk and would equally meet eligibility criteria.
* Subjects must have the ability to understand and the willingness to sign a written informed consent document.
* Subjects must have the ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* History of prior EGD procedure in past ten years
* 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 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 of uncomplicated surgical fundoplication procedure

Where it's running

• University of Colorado
  Aurora, Colorado, United States Recruiting
• Johns Hopkins Hospital
  Baltimore, Maryland, United States Recruiting
• University of North Carolina at Chapel Hill
  Chapel Hill, North Carolina, United States Recruiting
• University Hospitals Cleveland Medical Center
  Cleveland, Ohio, United States Recruiting
• Cleveland Clinic Taussig Cancer Center
  Cleveland, Ohio, United States Recruiting

Study contacts

• Principal investigator: Amitabh Chak, MD — University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
• Study coordinator: Wendy Brock
• Email: Wendy.brock@uhhospitals.org
• Phone: 216-844-3853

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Assessing Barrett's Esophagus in Patients with Anorexia Nervosa and Purging Behaviors

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• Using a swallowable sponge to collect esophageal samples for Barrett's esophagus detection

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• Registry for patients undergoing esophageal cancer screening

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• Comparing biopsy methods for monitoring Barrett's Esophagus

  This study is testing whether a new biopsy method called WATS is better than the usual random biopsies for monitoring patients with Barrett's Esophagus who are at high risk for serious complications.

  Recruiting Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Amsterdam, North Holland · NCT05642338

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.