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

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic Test
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: No
View:

• 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).

Locations
United States
Ohio
University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
Recruiting
Cleveland
Contact Information
Primary
Amitabh Chak, MD
CTUReferral@UHhospitals.org
1-800-641-2422
Time Frame
Start Date: January 5, 2022
Estimated Completion Date: December 2025
Participants
Target number of participants: 500
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: Case Comprehensive Cancer Center

This content was sourced from clinicaltrials.gov

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