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Cancer Detection
EsoGuard + EsoCheck 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
Be older than 18 years old
Must not have
History of weekly or 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to find a new way to detect Barrett's esophagus using a simple office-based test. Barrett's esophagus is a condition where the lining of the food pipe is damaged by
Who is the study for?
This trial is for individuals who may be at risk of Barrett's esophagus but do not have chronic symptoms of gastroesophageal reflux disease (GERD). Participants will answer a questionnaire, undergo the EsoCheck test, and have their samples analyzed with EsoGuard. They must also be willing to have an upper endoscopy.
What is being tested?
The trial is testing the effectiveness of a new office-based diagnostic method using two tests: EsoCheck, a capsule balloon test; and EsoGuard, a laboratory analysis designed to detect Barrett's esophagus in patients without typical GERD symptoms.
What are the potential side effects?
Potential side effects are not detailed here but could include discomfort or complications from the capsule balloon test (EsoCheck) or reactions related to the upper endoscopy procedure as part of standard care.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had heartburn or acid reflux at least once a week for over five years.
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I am on blood thinners that can't be stopped or have a clotting disorder with INR > 1.5.
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I have a history of swollen veins or narrowing in my esophagus.
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I have trouble or pain when swallowing, including pills.
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My cancer is located in the oropharynx.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
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
EsoCheck
2020
N/A
~20
EsoGuard
2020
N/A
~150
Find a Location
Who is running the clinical trial?
Case Comprehensive Cancer CenterLead Sponsor
468 Previous Clinical Trials
32,636 Total Patients Enrolled
Amitabh Chak, MDPrincipal InvestigatorUniversity Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
2 Previous Clinical Trials
2,500 Total Patients Enrolled