Multi-Site Detection of Barrett's Esophagus in Patients Without Chronic GERD Symptoms

Part of paid clinical trials in Aurora, Colorado.

Sponsor
Case Comprehensive Cancer Center
Study ID
NCT06687603
Status
Recruiting
Apply to this trial

Conditions

  • Barrett Esophagus
  • Esophageal Adenocarcinoma
  • Gastroesophageal Reflux

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • EsoCheck — DEVICE
    FDA-approved, non-endoscopic, encapsulated swallowable balloon. EsoCheck will produce a sample which will subsequently be tested with EsoGuard assay. The EsoCheck is performed and completed in approximately 5 minutes.
  • EsoGuard — DIAGNOSTIC_TEST
    Approved laboratory, methylated DNA panel that detects esophageal neoplasia. The EsoGuard assay tests the EsoCheck samples to detect BE in GERD participants.

Study Details

The goal of this clinical trial is to develop a method to detect Barrett's esophagus in individuals with a new office based diagnostic test. Barrett's esophagus is a condition in which the flat pink lining of the swallowing tube that connects the mouth to the stomach (the esophagus) becomes damaged by acid reflux. The main question it aims to answer is: Can this approach demonstrate efficacy for screening of Barrett's esophagus? Participants will: * Participate in a questionnaire. * Undergo a capsule balloon test, called EsoCheck. * Have their EsoCheck sample sent to the laboratory for an EsoGuard test, which is used to detect Barrett's esophagus. * Participants will undergo upper endoscopy as part of standard of care.

Key Dates

Start date
Mar 10, 2025
Status verified
Nov 2025
Primary completion
Sep 27, 2028
Completion
Sep 27, 2029

Study Design

Enrollment
800 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: EsoCheck + EsoGuard
    Participants will undergo an EsoCheck test. The sample produced by the EsoCheck will be sent to LucidDx where the EsoGuard assay will be performed.

Primary Outcome Measure

Positive predictive value for Barret's Esophagus in EsoCheck/EsoGuard positive participants [ Time Frame: Up to 5 years ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
University of ColoradoAuroraColorado80045
Sachin Wani, MD
Sachin Wani, MD (PRINCIPAL_INVESTIGATOR)
Johns Hopkins HospitalBaltimoreMaryland21287
Marcia Canto, MD
Marcia Canto, MD (PRINCIPAL_INVESTIGATOR)
University of North Carolina at Chapel HillChapel HillNorth Carolina027599
Nicholas Shaheen, MD
Nicholas Shaheen, MD (PRINCIPAL_INVESTIGATOR)
Cleveland Clinic Taussig Cancer CenterClevelandOhio44195
Prashanti Thota, MD
Prashanti Thota, MD (PRINCIPAL_INVESTIGATOR)
University Hospitals Cleveland Medical CenterClevelandOhio44016
Amitabh Chak, MD
Amitabh Chak, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Aurora, CO

By research site
University of Colorado· Aurora, COJohns Hopkins Hospital· Baltimore, MDUniversity of North Carolina at Chapel Hill· Chapel Hill, NCCleveland Clinic Taussig Cancer Center· Cleveland, OHUniversity Hospitals Cleveland Medical Center· Cleveland, OH

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