EsoGuard + EsoCheck for Barrett's Esophagus

Recruiting at 4 trial locations

Overseen By Wendy Brock

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Case Comprehensive Cancer 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: 2

800 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to develop a new office-based test to detect Barrett's esophagus, a condition caused by acid reflux damaging the esophagus lining. The trial will evaluate a capsule balloon test called EsoCheck, with samples analyzed by the EsoGuard test. Participants will also undergo a standard upper endoscopy. Ideal candidates are individuals without frequent heartburn but with risk factors like central obesity or a smoking history, who have not had an esophagus examination in the past ten years.

As an unphased trial, this study offers participants the chance to contribute to innovative research that could lead to easier detection methods for Barrett's esophagus.

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 chronic anticoagulation therapy that cannot be temporarily stopped.

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

Previous studies have shown the EsoCheck and EsoGuard system to be safe. Research indicates that the FDA has approved the EsoCheck device, confirming its safety for use. EsoGuard, which examines cells collected by EsoCheck, detects Barrett's esophagus, a condition affecting the esophagus due to acid reflux.

These tools are designed to be user-friendly and non-invasive. Patients generally handle both the capsule balloon test (EsoCheck) and the follow-up test (EsoGuard) without major issues. Studies have not reported any significant negative effects from these methods, suggesting that the procedures are safe and well-tolerated by participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about EsoCheck and EsoGuard for Barrett's Esophagus because these tools offer a less invasive way to detect changes in the esophagus that could lead to cancer. Unlike traditional endoscopies, which require sedation and involve inserting a flexible tube down the throat, EsoCheck is a swallowable, balloon-like capsule that collects cells from the esophagus lining. These cells are then analyzed using the EsoGuard assay, which can identify DNA markers associated with Barrett's Esophagus. This non-invasive approach could make screening more accessible and comfortable, potentially catching issues earlier and improving patient outcomes.

What evidence suggests that this method is effective for detecting Barrett's esophagus?

Research has shown that EsoGuard, when used with EsoCheck, holds promise for detecting Barrett's esophagus. In this trial, participants will undergo an EsoCheck test, and the sample will be analyzed using the EsoGuard assay. Studies indicate that EsoGuard accurately identifies 92.9% of true cases and effectively rules out the condition 98.6% of the time. One study found that using EsoGuard with EsoCheck improves the chances of detecting the condition compared to traditional methods alone. Previous uses of these tests reported no serious side effects. Overall, these findings suggest that EsoGuard and EsoCheck could be effective tools for screening Barrett's esophagus. ^{2 3 6 7 8}

Who Is on the Research Team?

Amitabh Chak, MD

Principal Investigator

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am over 50, can consent, have not had an EGD in 10 years, don't have GERD, and have two risk factors for BE.

I am getting a screening colonoscopy, which qualifies me for BE screening.

I can understand and am willing to sign the consent form.

Exclusion Criteria

I have no medical conditions that prevent me from undergoing esophageal checks or biopsies.

I have had heartburn or acid reflux at least once a week for over five years.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Diagnostic Testing

Participants undergo a questionnaire, EsoCheck test, and EsoGuard assay to detect Barrett's esophagus

1-2 weeks

1 visit (in-person)

Endoscopy

Participants undergo upper endoscopy as part of standard of care to confirm Barrett's esophagus

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after diagnostic testing and endoscopy

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• EsoCheck
• EsoGuard

Trial Overview 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.

How Is the Trial Designed?

Group I: EsoCheck + EsoGuard Experimental Treatment 2 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.

Who Is Running the Clinical Trial?

Case Comprehensive Cancer Center

Lead Sponsor

Trials

472

Recruited

33,400+

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

Enhancing the Diagnostic Yield of EGD for Diagnosis of ... Compared with screening EGD alone, it improves diagnostic yield. This may help direct more efficient use of endoscopy resources to improve disease detection in ...

3. luciddx.com luciddx.com/clinical-data

Clinical Data Results show BE/EAC prevalence of 12.9%, and EsoGuard had high sensitivity (92.9%) and strong negative predictive value (98.6%) for detection of disease. No ...

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

EsoGuard BE-1 Trial Validates Effective Screening ... EsoGuard demonstrated promise in the detection of esophageal precancer (Barrett's Esophagus; BE) and esophageal adenocarcinoma (EAC), ...

5. medrxiv.org medrxiv.org/content/10.1101/2024.06.24.24309401v2

Use of the EsoGuard® Molecular Biomarker Test in Non- ... Mild esophageal abrasions were observed in 1.5%; no serious adverse events were reported. Conclusions EG/EC appears effective for BE screening. ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04293458

Study Details | NCT04293458 | Efficacy of EsoGuard on ... The study will assess the performance of the combined system, i.e., the use of the EsoGuard assay on cells collected using the EsoCheck 510(k) cleared device, ...

7. prevention.cancer.gov prevention.cancer.gov/news-and-events/blog/new-technology-gives-patients-access-5-minute-office-based-test-identify-risk

New Technology Gives Patients Access to a 5-Minute, Office ... EsoCheck™ and EsoGuard™ are the device and test created for the detection of Barrett's esophagus, the benign and treatable precursor condition ...

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

Use of the EsoGuard® Molecular Biomarker Test in Non- ... To conclude, this study in the intended-use screening population of patients at high-risk for BE/EAC demonstrated non-endoscopic cell collection ...