Nonendoscopic Screening for Barrett's Esophagus

Overseen By Lauren H. Hricik, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Cleveland VA Medical Research and Education Foundation

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

Trial Summary

What is the purpose of this trial?

The veteran population is at increased risk for EAC and its precursor lesion, Barrett's esophagus (BE), due to increased prevalence of disease risk factors compared to the general population. BE is traditionally diagnosed only when patients undergo endoscopy with biopsies. However, due to the high cost of endoscopy and the lack of studies proving efficacy of screening, endoscopy to screen for BE is not routinely recommended. A simpler screening procedure similar to a pap smear would be an ideal way to sample the esophageal tissue for cancer and its precursor condition, BE. This study proposes a non-endoscopic detection method administered in outpatient offices which would increase subsequent endoscopic detection of BE. The study team will be enrolling veterans who do not have history of gastroesophageal reflux but have multiple risk factors for esophageal adenocarcinoma.

Research Team

Katarina B Greer, MD/MS

Principal Investigator

Cleveland VA Research and Education Foundation

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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?

Cleveland VA Medical Research and Education Foundation

Lead Sponsor

Trials

2

Recruited

530+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+