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Diagnostic Test
Diagnostic Tests for Detecting Barrett's Esophagus
N/A
Recruiting
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
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.
No significant dysphagia or odynophagia
Must not have
History of weekly of more frequent heartburn or regurgitation for five or more years
On anti-coagulant drug(s) that cannot be temporarily discontinued or coagulopathy with international normalized ratio (INR) > 1.5
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 months
Awards & highlights
Summary
This trial is testing a new office-based diagnostic test to see if it can effectively detect Barrett's Esophagus in patients.
Who is the study for?
This trial is for individuals over 50 with no chronic GERD, who have two risk factors for Barrett's Esophagus such as being white, having central obesity, male gender, smoking history or a family history of the condition. They must not have swallowing difficulties or blood clotting issues.
What is being tested?
The study aims to test a new office-based diagnostic method called EsoCheck/EsoGuard (EC/EG) against the standard Esophago-gastro-duodenoscopy (EGD) procedure in detecting Barrett's Esophagus in patients without typical GERD symptoms.
What are the potential side effects?
Potential side effects are not detailed but may include discomfort from the procedures and risks associated with biopsies like bleeding or infection. The EGD procedure could also cause reactions related to sedation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I haven't had chronic heartburn or acid reflux for 5+ years.
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I do not have severe swallowing pain or difficulty.
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I don't have blood clotting disorders or swollen veins in my esophagus.
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I do not have any known blood clotting disorders or esophageal varices.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have experienced heartburn or regurgitation weekly for over five years.
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I am on blood thinners that can't be stopped or have a clotting disorder with an 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 2 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Positive predictive value (PPV) of EC/EG in a non-GERD population that has three or more non-GERD risk factors for BE.
Proportion of participants negative via EC/EG who subsequently are proven negative via EGD
Trial Design
1Treatment groups
Experimental Treatment
Group I: EC/EG & EGDExperimental Treatment2 Interventions
Participants will complete a study questionnaire about reflux symptoms. Performance of an EsoCheck (EC) procedure; the EC sample will subsequently be tested with the EsoGuard (EG) assay
If EG assay results come back positive, participant is requested to complete standard of care (SOC) upper endoscopy (tissue samples collected)
If EG assay results come back negative, selected participants (100 volunteers) will also undergo a research EGD if they consent
Find a Location
Who is running the clinical trial?
Case Comprehensive Cancer CenterLead Sponsor
462 Previous Clinical Trials
32,063 Total Patients Enrolled
Amitabh Chak, MDPrincipal InvestigatorUniversity Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
1 Previous Clinical Trials
2,000 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I don't have health issues that prevent me from undergoing specific esophageal exams or biopsies.I am over 50 and have at least two risk factors for Barrett's esophagus.I haven't had chronic heartburn or acid reflux for 5+ years.I am over 50 and have at least two risk factors for Barrett's esophagus.I have experienced heartburn or regurgitation weekly for over five years.I haven't had chronic heartburn or acid reflux for 5+ years.I have not had a heart attack or stroke in the last 6 months.I am on blood thinners that can't be stopped or have a clotting disorder with an INR > 1.5.I do not have severe swallowing pain or difficulty.I don't have blood clotting disorders or swollen veins in my esophagus.I have a history of swollen veins or narrowing in my esophagus.I have had an EGD procedure before.I have had surgery on my esophagus or stomach, but it was only a simple fundoplication.I have trouble or pain when swallowing, including pills.My cancer is located in the oropharynx.I do not have any known blood clotting disorders or esophageal varices.
Research Study Groups:
This trial has the following groups:- Group 1: EC/EG & EGD
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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