Nonendoscopic Screening for Barrett's Esophagus

Overseen By Lauren H. Hricik, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Louis Stokes VA Medical Center

Must not be taking: Anticoagulants

Disqualifiers: GERD, Esophageal varices, Dysphagia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to find a simpler, more affordable way to screen for Barrett's esophagus (BE), a condition that can lead to esophageal cancer, particularly in veterans with multiple risk factors. Instead of using traditional endoscopy, which is costly and invasive, the study tests a new method called Esocheck/Esoguard, a nonendoscopic screening tool that could be performed in a regular doctor's office. Ideal participants are veterans without chronic heartburn but with at least three risk factors, such as obesity, smoking, or a family history of esophageal conditions.

As an unphased trial, this study allows participants to contribute to important research that could simplify and improve screening methods for BE.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on anti-coagulant drugs that cannot be temporarily stopped.

What prior data suggests that this non-endoscopic screening method is safe for detecting Barrett's esophagus?

Research has shown that EsoCheck and EsoGuard are promising tools for detecting Barrett's esophagus, a condition that can lead to esophageal cancer. EsoGuard, in particular, is about 90% effective at correctly identifying Barrett's esophagus and esophageal cancer.

These tests are safe and easy to use, as they don't require surgery or complex procedures. EsoCheck collects cells from the esophagus without needing an endoscopy, which involves a camera tube. Participants in studies have not reported any major side effects, making it a potentially safer option for screening.

Since this technology is already used to detect Barrett's esophagus, it appears to be safe. However, discussing personal health with a doctor before joining a trial is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Esocheck and Esoguard because they offer a nonendoscopic approach to screening for Barrett's Esophagus, which typically requires an invasive procedure called an upper endoscopy. Esocheck is a simple, less invasive method for collecting cells from the esophagus, making it more accessible and comfortable for patients. Additionally, the Esoguard assay tests these samples for specific biomarkers (mVIM and mCCNA1) associated with Barrett's Esophagus, providing a targeted and precise screening method. This combination has the potential to make early detection easier and more widespread, which is a major advantage over traditional methods.

What evidence suggests that Esocheck/Esoguard is effective for screening Barrett's esophagus?

Research has shown that EsoCheck and EsoGuard effectively detect Barrett's esophagus (BE) without invasive procedures. In this single-arm trial, participants will undergo two diagnostic tests: EsoCheck and EGD. The EsoGuard BE-1 trial demonstrated that this method reliably identifies early signs of esophageal cancer, such as BE, by analyzing cell samples from the esophagus. Current data suggests that using EsoCheck and EsoGuard could significantly improve the detection rate of BE, which remains below 10% with traditional methods. This non-invasive approach makes screening easier and more accessible for patients, potentially catching BE early and improving outcomes. ^{2 3 6 7 8}

Who Is on the Research Team?

Katarina B Greer, MD/MS

Principal Investigator

Cleveland VA Research and Education Foundation

Are You a Good Fit for This Trial?

This trial is for veterans aged 40-85 without chronic reflux but with multiple risk factors for esophageal cancer, such as being white, male, obese (BMI > 30), having a significant smoking history (>10 pack years), or family history of Barrett's Esophagus or esophageal cancer. They must not have had prior upper endoscopies and should be able to consent.

Inclusion Criteria

I am between 40 and 85 years old, have never had an EGD, and can consent.

I do not have severe swallowing pain or difficulty.

I don't have chronic GERD but qualify for a screening for Barrett's Esophagus.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Non-endoscopic Screening

Participants undergo non-endoscopic biomarker-based screening for Barrett's esophagus using Esocheck and Esoguard assay

1-2 weeks

1 visit (in-person)

Endoscopic Confirmation

Participants who test positive in the non-endoscopic screening undergo upper endoscopy for confirmation

1-2 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after screening and endoscopy

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Esocheck/Esoguard

Trial Overview The study tests a non-endoscopic screening method called Esocheck/Esoguard compared to traditional diagnostic upper endoscopy in detecting Barrett's Esophagus. It aims to find an easier way to screen veterans at high risk for esophageal adenocarcinoma in outpatient settings.

How Is the Trial Designed?

Group I: This is a single arm study. Participants will complete 2 diagnostic tests: Esocheck and EGD. Experimental Treatment 1 Intervention

Patients without history of GERD receiving care in Wade Park VA will be approached regarding BE screening. Reasons for refusal of screening will be recorded. Adult subjects without history of gastroesophageal reflux with three or more risk factors- white race, male gender, obesity (BMI \> 30), smoking, or family history will be included. Only those patients who have not had prior EGD will be candidates for Esocheck screening. Distal esophageal samples will be assayed for mVIM + mCCNA1 (Esoguard assay). All patients will be offered upper endoscopy.

Who Is Running the Clinical Trial?

Louis Stokes VA Medical Center

Lead Sponsor

Trials

21

Recruited

4,100+

Cleveland VA Medical Research and Education Foundation

Lead Sponsor

Trials

2

Recruited

530+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04295811

Efficacy of EsoGuard Assay on Esophageal Surface Cells ... The primary efficacy objectives of this study are to measure the sensitivities of EsoGuard-based diagnosis in 54 cases each of non-dysplastic Barrett's ...

2. luciddx.com luciddx.com/clinical-data

Clinical Data The study showcases the effectiveness of EsoCheck, a non-endoscopic device, in providing esophageal cell samples that can be used for a multitude of cytology ...

3. uhhospitals.org uhhospitals.org/for-clinicians/articles-and-news/articles/2025/05/esocheck-esoguard-revolutionary-invention-transforms-esophageal-cancer-diagnostics

EsoCheck™ & EsoGuard Currently, less than 10% of BE is detected. Use of EsoCheck™ & EsoGuard™ would enable more widespread screening by testing patients in an office ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12100536/

Enhancing the Diagnostic Yield of EGD for Diagnosis of ... EG triage enriches the population undergoing EGD for BE detection. Compared with screening EGD alone, it improves diagnostic yield.

5. targetedonc.com targetedonc.com/view/esoguard-be-1-trial-validates-effective-screening-for-esophageal-precancer

EsoGuard BE-1 Trial Validates Effective Screening ... The ESOGUARD BE-1 trial demonstrated that the EsoGuard test, combined with EsoCheck, effectively detects esophageal precancer and supports its use as a ...

6. luciddx.com luciddx.com/precancer-detection/esoguard

EsoGuard With ~90% sensitivity and ~99% negative predictive value at detecting Barrett's esophagus1,2,3 and esophageal adenocarcinoma,1,2 the EsoGuard test allows ...

7. medrxiv.org medrxiv.org/content/10.1101/2024.06.24.24309401v2.full.pdf

Use of the EsoGuard® Molecular Biomarker Test in Non- ... Levine, D.S., et al., An endoscopic biopsy protocol can differentiate high-grade dysplasia from early adenocarcinoma in Barrett's esophagus.

8. medschool.cuanschutz.edu medschool.cuanschutz.edu/deans-office/cu-med-today/featuresarchives/clinical-trial-tests-device-for-screening-esophageal-cancer

Clinical Trial Tests Device for Screening Esophageal Cancer Currently, Wani says, people are only tested for Barrett's esophagus if they have acid reflux symptoms that have been ongoing for five years or have significant ...