RECRUITING

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

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 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.

Official Title

Nonendoscopic Screening for Barrett's Esophagus and Esophageal Cancer in At-Risk Veterans Without History of Chronic Gastroesophageal Reflux

Quick Facts

Study Start:2025-04-11
Study Completion:2028-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06746623

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:40 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients without history of chronic GERD who meet criteria for upper endoscopic screening for BE will be accrued35.
  2. 1. Adults \> 40 and \< 85 years old who have no prior EGD and can provide informed consent
  3. 2. Absence of chronic GERD symptoms (absence of weekly heartburn or regurgitation, not on medications for GERD), and are:
  4. 3. No known coagulopathy, no known esophageal varices, not on chronic anticoagulation therapy, and have:
  5. 4. No significant dysphagia or odynophagia
  1. * Exclusion Criteria
  2. 1. History of prior EGD procedure in past ten years
  3. 2. Inability to provide written informed consent
  4. 3. History of weekly or more frequent heartburn or regurgitation for five or more years
  5. 4. On anti-coagulant drug(s) that cannot be temporarily discontinued or coagulopathy with INR \> 1.5
  6. 5. Known history of esophageal varices or esophageal stricture
  7. 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
  8. 7. History of difficulty swallowing (dysphagia) or painful swallowing (odynophagia), including swallowing pills
  9. 8. Oropharyngeal tumor
  10. 9. History of esophageal or gastric surgery, with exception on uncomplicated recent surgical fundoplication procedure with documented normal acid exposure time (AET) percent (AET \<4%)
  11. 10. History of myocardial infarction or cerebrovascular accident within past 6 months

Contacts and Locations

Study Contact

Katarina B. Greer, MD/MS
CONTACT
216-791-3800
katarina.greer@va.gov
Lauren H. Hricik, BA
CONTACT
(216) 791-3800
lauren.hricik@va.gov

Principal Investigator

Katarina B Greer, MD/MS
PRINCIPAL_INVESTIGATOR
Cleveland VA Research and Education Foundation

Study Locations (Sites)

VA Northeast Ohio Healthcare System
Cleveland, Ohio, 44106
United States

Collaborators and Investigators

Sponsor: Cleveland VA Medical Research and Education Foundation

  • Katarina B Greer, MD/MS, PRINCIPAL_INVESTIGATOR, Cleveland VA Research and Education Foundation

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 Date2025-04-11
Study Completion Date2028-12-31

Study Record Updates

Study Start Date2025-04-11
Study Completion Date2028-12-31

Terms related to this study

Keywords Provided by Researchers

  • Non-endoscopic screening
  • esophagus
  • Barrett

Additional Relevant MeSH Terms

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