Barrett Esophagus, Esophageal Cancer, GERD, Obesity
Conditions
Keywords
Barrett Esophagus, Screening
Brief 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
Interventions
DIAGNOSTIC_TESTEsocheck/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.
Sponsors
United States Department of Defense
Louis Stokes VA Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
Patients who have symptomatic GERD and also meet criteria for upper endoscopic screening for BE will be accrued. Eligible patients will include: 1. Adult Veterans \> 40 and \< 85 years old who have no prior EGD and can provide informed consent 2. No known coagulopathy, no known esophageal varices. 3. No significant dysphagia or odynophagia 4. Documented GERD or use of proton pump inhibitors (PPIs) for \> 5 years 5. Meet ACG Clinical Guideline criteria for BE screening (that require presence of multiple risk factors 21). Eligible subjects to qualify must have will have GERD plus at least two additional risk factors for BE (white race, obesity defined as BMI \> 30, male gender, smoking history, family history).
Exclusion criteria
1. Patients with known coagulopathy (INR \> 1.5) will be excluded 2. Patients with known esophageal varices will be excluded. 3. Patients with significant dysphagia (unable to swallow solids) or odynophagia will be excluded
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity and Specificity of Esocheck/Esoguard in a Veteran population | Through study completion, up to 2.5 years | The accuracy of a test which reports the presence or absence of a condition, in comparison to a 'Gold Standard' |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number/percentage of screened patients with diagnosis of Barrett's esophagus and/or esophageal adenocarcinoma | Through study completion, up to 2.5 years | Compare diagnostic yield of EGD to diagnostic yield of Esocheck/Esoguard in Veterans |
| Cost of two screening strategies | Through study completion, up to 2.5 years | Compare the cost of screening all enrolled patients by EGD alone vs. cost of selective screening by EGD in patients who have had a positive Esocheck/Esoguard test |
Countries
United States
Contacts
Primary ContactJeffrey Moore, PhD
Backup ContactMarcie Denallo, BS
Outcome results
None listed