← Back to Search

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

No Placebo-Only Group

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 below

Select...

I haven't had chronic heartburn or acid reflux for 5+ years.

Select...

I do not have severe swallowing pain or difficulty.

Select...

I don't have blood clotting disorders or swollen veins in my esophagus.

Select...

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.

Select...

I am on blood thinners that can't be stopped or have a clotting disorder with an INR > 1.5.

Select...

I have a history of swollen veins or narrowing in my esophagus.

Select...

I have trouble or pain when swallowing, including pills.

Select...

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 months for reporting.

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

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: 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

0 / 9Eligibility criteria met