Detection of Barrett s Esophagus in Patients Without GERD Symptoms

Detection of Barrett s Esophagus in Patients Without Gastroesophageal Reflux Disease (GERD) Symptoms

The purpose of this study is to develop a method to detect Barrett's esophagus (BE) in individuals with a new office-based diagnostic test.

Study Overview

• Status: Recruiting
• Conditions: Barrett's Esophagus
• Intervention / Treatment: Diagnostic test: EsoCheck/EsoGuard (EC/EG); Diagnostic test: Esophago-gastro-duodenoscopy (EGD)

Detailed Description

This study will investigate whether using EsoCheck/EsoGuard(EC/EG) can detect BE in individuals at risk for BE who are currently not being detected and are not undergoing routine esophago-gastro-duodenoscopy (EGD)

BE can only be diagnosed by performing upper endoscopy. Up to 500 adults who have risk factors for BE but do not have chronic heartburn or regurgitation will be enrolled in this study. This will include the EsoCheck/EsoGuard determination along with the upper endoscopy for qualifying EsoGuard negative subjects

• Study Type: Interventional
• Enrollment (Estimated): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Amitabh Chak, MD; Phone Number: 1-800-641-2422; Email: CTUReferral@UHhospitals.org

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106-5065
      • Recruiting
      • University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
      • Principal Investigator: Amitabh Chak, MD
      • Contact: Amitabh Chak, MD; Phone Number: 800-641-2422; Email: CTUReferral@UHhospitals.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• No known coagulopathy, no known esophageal varices.
• No significant dysphagia or odynophagia
• Absence of chronic GERD, defined as five or more years of heartburn or regurgitation with symptoms at least once a week when not on medications for GERD symptoms.
• Subjects to qualify must meet criterion 3, be over age 50, and have two additional risk factors for BE (white race, central obesity defined as waist size >35 inches for women and >40 inches for men, male gender, current smoker or smoking history >10 pack years, confirmed family history in at least two members with one being a first degree relative).

Exclusion Criteria:

• History of prior EGD procedure
• Inability to provide written informed consent
• History of weekly of more frequent heartburn or regurgitation for five or more years
• On anti-coagulant drug(s)that cannot be temporarily discontinued or coagulopathy with international normalized ratio (INR) > 1.5
• Known history of esophageal varices or esophageal stricture
• Any contraindication, as deemed inInvestigator's medical judgment, to undergoing the EsoCheck procedure, undergoing the EGDprocedure,and/or having biopsies taken, including but not limited to due to comorbidities such as coagulopathy or a known history of esophageal diverticula, esophageal fistula and/or esophageal ulceration
• History of difficulty swallowing (dysphagia) or painful swallowing (odynophagia), including swallowing pills
• Oropharyngeal tumor
• History of esophageal or gastric surgery, with exception on uncomplicated surgical fundoplication procedure
• History of myocardial infarction or cerebrovascular accident within past 6 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: EC/EG & EGD; Participants will complete a study questionnaire about reflux symptoms. Performance of an EsoCheck (EC) procedure; the EC sample will subsequently be tested with the EsoGuard (EG) assay If EG assay results come back positive, participant is requested to complete standard of care (SOC) upper endoscopy (tissue samples collected) If EG assay results come back negative, selected participants (100 volunteers) will also undergo a research EGD if they consent

Diagnostic test: EsoCheck/EsoGuard (EC/EG); EC is a swallowed capsule on a tethered catheter that obtains a touch sample of the distal esophagus. The obtained sample is placed in a buffer and sent to a diagnostics lab for testing of methylated markers from extracted DNA. EG is a methylated DNA test . A positive EG is associated with Barrett's esophagus at all its stages.; Diagnostic test: Esophago-gastro-duodenoscopy (EGD); SOC diagnostic endoscopic procedure that visualizes the upper part of the gastrointestinal tract down to the duodenum. Tissue samples collected.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positive predictive value (PPV) of EC/EG in a non-GERD population that has three or more non-GERD risk factors for BE.	PPV of EC/EG in a non-GERD population that has three or more non-GERD risk factors for BE. Participants who are at risk will be offered EC/EG. Those who are positive will undergo subsequent EGD PPV = (EC/EG positive & EGD positive) / ((EC/EG positive & EGD positive) + (EC/EG positive & EGD negative))	Up to 2 months
Proportion of participants negative via EC/EG who subsequently are proven negative via EGD	Negative Predictive Value (NPV): Proportion of participants negative via EC/EG who subsequently are proven negative via EGD. This will be measured by offering EGD to a proportion of patients who are EC/EG negative.	Up to 2 months

Collaborators and Investigators

• Sponsor: Case Comprehensive Cancer Center
• Investigators: Principal Investigator: Amitabh Chak, MD, University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2022
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: May 5, 2021
• First Submitted That Met QC Criteria: May 5, 2021
• First Posted (Actual): May 10, 2021

Study Record Updates

• Last Update Posted (Actual): August 21, 2023
• Last Update Submitted That Met QC Criteria: August 16, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Gastrointestinal Diseases; Esophageal Diseases; Precancerous Conditions; Barrett Esophagus
• Other Study ID Numbers: CASE1221

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All individual participant data (IPD) that result in publication
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes