NCT05210049

Non-endoscopic Esophageal Sampling to Detect Barrett's Esophagus and Esophageal Cancer in Veterans

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 125 (estimated)
• Sponsor: Louis Stokes VA Medical Center · Federal
• Sex: All
• Age: 40 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This study seeks to incorporate non-endoscopic detection method (Esocheck/Esoguard) in primary care practice and test whether this screening modality increases the positive predictive value of upper endoscopy and increases the detection of Barrett's esophagus and esophageal cancer.

Detailed description

This study addresses prevention and early detection of esophageal adenocarcinoma (EAC). Prospectively collected Surveillance Epidemiology and End Results (SEER) data indicate that the incidence of esophageal adenocarcinoma (EAC) has increased more than 6-fold in the past four decades. The prognosis for patients with EAC is poor with less than 20% of patients surviving beyond 5 years. 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 including advanced age, gastroesophageal reflux, caucasian race, male sex, smoking history, and obesity compared to the general population. Research has shown that veterans often present with an advanced cancer stage, despite opportunities to screen for BE in veterans with known risk factors. Therefore, there is an urgent clinical need to improve strategies for the detection and prevention of BE and EAC. Currently, BE is diagnosed only when patients undergo endoscopy with esophagogastroduodenoscopy (EGD). However, due to the high cost of EGD and the lack of a randomized controlled trials supporting its efficacy, endoscopy to screen for BE is not routinely recommended. Current guidelines do recommend sedated EGD in patients with multiple BE risk factors, refractory GERD, or alarm symptoms. This strategy fails to detect BE in patients whose symptoms are well controlled with either over the counter medications or physician prescribed therapies. It also fails to detect BE in asymptomatic subjects who comprise 40% of those that develop EAC. Thus, less than 10% of esophageal adenocarcinomas are diagnosed as early stage lesions caught by surveillance of patients with previously detected BE. Ablative non-surgical therapies that have been developed for preventing cancer in patients with BE with high grade dysplasia over the past decade will have little impact and the 5 year survival for esophageal adenocarcinomas will remain a dismal 18% unless more effective programs for identifying BE and early EAC are developed. The main hypothesis of this study is that incorporation of a non-endoscopic detection method in primary care practice will increase the positive predictive value of EGD and increase the detection of BE. The objective of this study is to incorporate a novel unsedated BE screening method for veterans at risk for EAC into a primary care practice at a VA hospital. Esocheck/Esoguard is a FDA approved device designed to sample the distal esophagus and analyze the collected material for presence of two methylated DNA markers. The Specific Aims of this study are: 1. To determine sensitivity, specificity, positive and negative predictive value of Esocheck/Esoguard performed in routine practice for detecting BE in an at risk Veteran population 2. To compare the yield of detected BE using EGD alone vs. stepwise molecular diagnostics(Esocheck/Esoguard) and endoscopic screening strategy (EGD) in at risk Veteran population

Conditions

• Barrett Esophagus
• GERD
• Obesity
• Esophageal Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Esocheck/Esoguard	All enrolled patients will complete the Esocheck screening test. EsoCheck is a cell collection device that is designed to collect cells of a targeted region of the esophagus. The collected cell material is examined with a two marker panel combining methylated CCNA1 and VIM. These methylated markers have 95% sensitivity and 91% specificity for detecting BE and EAC with an AUC=0.95 in studies performed among white men. Diagnostic yield of this test among Veterans is unknown.

Timeline

• Start date: 2022-03-01
• Primary completion: 2024-08-31
• Completion: 2024-08-31
• First posted: 2022-01-27
• Last updated: 2022-12-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study