RECRUITING

Multi-Site Detection of Barrett's Esophagus in Patients Without Chronic GERD Symptoms

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Conditions

Barrett EsophagusGastroesophageal RefluxEsophageal AdenocarcinomaEsophagusNon-endoscopic

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this clinical trial is to develop a method to detect Barrett's esophagus in individuals with a new office based diagnostic test. Barrett's esophagus is a condition in which the flat pink lining of the swallowing tube that connects the mouth to the stomach (the esophagus) becomes damaged by acid reflux. The main question it aims to answer is: Can this approach demonstrate efficacy for screening of Barrett's esophagus? Participants will: * Participate in a questionnaire. * Undergo a capsule balloon test, called EsoCheck. * Have their EsoCheck sample sent to the laboratory for an EsoGuard test, which is used to detect Barrett's esophagus. * Participants will undergo upper endoscopy as part of standard of care.

Official Title

Multi-Site Detection of Barrett's Esophagus in Patients Without Chronic GERD Symptoms

Quick Facts

Study Start:2025-03-10
Study Completion:2029-09-27
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06687603

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adults who have not had prior EGD within past ten years, and are able to provide informed consent, and who have:
  2. * No known coagulopathy, no known esophageal varices, not on chronic anticoagulation therapy, and have:
  3. * No significant dysphagia or odynophagia; but who do have:
  4. * Absence of GERD (absence of weekly heartburn or regurgitation, not on medications for GERD), and are:
  5. * 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.
  6. * Subjects must have the ability to understand and the willingness to sign a written informed consent document.
  7. * Subjects must have the ability to understand and the willingness to sign a written informed consent document.
  1. * History of prior EGD procedure in past ten years
  2. * Inability to provide written informed consent
  3. * History of weekly of 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 of uncomplicated surgical fundoplication procedure

Contacts and Locations

Study Contact

Wendy Brock
CONTACT
216-844-3853
Wendy.brock@uhhospitals.org

Principal Investigator

Amitabh Chak, MD
PRINCIPAL_INVESTIGATOR
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Study Locations (Sites)

University of Colorado
Aurora, Colorado, 80045
United States
Johns Hopkins Hospital
Baltimore, Maryland, 21287
United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 027599
United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44016
United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
United States

Collaborators and Investigators

Sponsor: Case Comprehensive Cancer Center

  • Amitabh Chak, MD, PRINCIPAL_INVESTIGATOR, University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-10
Study Completion Date2029-09-27

Study Record Updates

Study Start Date2025-03-10
Study Completion Date2029-09-27

Terms related to this study

Keywords Provided by Researchers

  • Esophagus
  • Non-endoscopic

Additional Relevant MeSH Terms

  • Barrett Esophagus
  • Gastroesophageal Reflux
  • Esophageal Adenocarcinoma