COMPLETED

Detection of Barrett s Esophagus in Patients Without GERD Symptoms

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Conditions

Barrett's Esophagus

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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 purpose of this study is to develop a method to detect Barrett's esophagus (BE) in individuals with a new office-based diagnostic test.

Official Title

Detection of Barrett s Esophagus in Patients Without Gastroesophageal Reflux Disease (GERD) Symptoms

Quick Facts

Study Start:2022-01-05
Study Completion:2025-02-25
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT04880044

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:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * No known coagulopathy, no known esophageal varices.
  2. * No significant dysphagia or odynophagia
  3. * Absence of chronic GERD, defined as five or more years of heartburn or regurgitation with symptoms at least once a week when not on medications for GERD symptoms.
  4. * Subjects to qualify must meet criterion 3, be over age 50, and have two additional risk factors for BE (white race, central obesity defined as waist size \>35 inches for women and \>40 inches for men, male gender, current smoker or smoking history \>10 pack years, confirmed family history in at least two members with one being a first degree relative).
  1. * History of prior EGD procedure
  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 international normalized ratio (INR) \> 1.5
  5. * Known history of esophageal varices or esophageal stricture
  6. * Any contraindication, as deemed inInvestigator's medical judgment, to undergoing the EsoCheck procedure, undergoing the EGDprocedure,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 on uncomplicated surgical fundoplication procedure
  10. * History of myocardial infarction or cerebrovascular accident within past 6 months

Contacts and Locations

Principal Investigator

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

Study Locations (Sites)

University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106-5065
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 Date2022-01-05
Study Completion Date2025-02-25

Study Record Updates

Study Start Date2022-01-05
Study Completion Date2025-02-25

Terms related to this study

Additional Relevant MeSH Terms

  • Barrett's Esophagus