← Back to Search

EsoCheck + EsoGuard for Barrett's Esophagus

N/A
Waitlist Available
Led By Amitabh Chak, MD
Research Sponsored by Case Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* 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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

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.

Eligible Conditions
  • Barrett's Esophagus
  • Acid Reflux
  • Esophageal Cancer
  • Gastroesophageal Reflux Disease

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Barrett's Esophagus prevalence in EsoCheck/EsoGuard test negative subjects from a high-risk GERD negative population
Positive predictive value for Barret's Esophagus in EsoCheck/EsoGuard positive participants
Tissue origins of true positive versus false positive EsoCheck/EsoGuard tests in non-GERD screening population

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: EsoCheck + EsoGuardExperimental Treatment2 Interventions
Participants will undergo an EsoCheck test. The sample produced by the EsoCheck will be sent to LucidDx where the EsoGuard assay will be performed.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
EsoGuard
2020
N/A
~150
EsoCheck
2020
N/A
~20

Find a Location

Who is running the clinical trial?

Case Comprehensive Cancer CenterLead Sponsor
468 Previous Clinical Trials
32,623 Total Patients Enrolled
Amitabh Chak, MDPrincipal InvestigatorUniversity Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
2 Previous Clinical Trials
2,500 Total Patients Enrolled
~533 spots leftby Sep 2028
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top