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

NCT ID: NCT06687603

Last Updated: 2025-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-10

Study Completion Date

2029-09-27

Brief Summary

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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.

Detailed Description

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The overall goal of this clinical trial is to eliminate deaths from Esophageal Adenocarcinoma (EAC) by demonstrating the efficacy of a non-endoscopic method for efficient population screening to detect all Barrett's esophagus (BE), the precursor lesion of EAC. EAC is a highly lethal malignancy with less than 20% 5-year survival, and an annual U.S. incidence \> 14,000 that has increased more than 6-fold in the past three decades. Barrett's esophagus, a pre-malignant metaplasia/neoplasia, is the precursor lesion of EAC, but is currently detectable only when patients undergo upper endoscopy (EGD). Despite Guideline recommendations for EGD in chronic GERD (gastrointestinal reflux disease) patients, barriers to EGD that include cost, sedation, and lack of acceptance, have so severely limited screening that antecedent BE remains undetected in over 95% of EAC cases. A major advance in EAC prevention was made by developing a non- endoscopic biomarker based method for detecting BE. The technology consists of an encapsulated swallowable balloon (EsoCheck) enabling a 5 minute non-endoscopic sampling of the esophagus, combined with a methylated DNA panel that detects esophageal neoplasia (EsoGuard). The research team validated the \> 90% sensitivity and specificity of EC+EG testing in the population of individuals who have symptomatic GERD, and who account for 60% of EAC cases. In this new proposal, the research team plans to double the impact of this technology to detect nearly all individuals harboring BE, by proving the EC+EG technology is so robust that it further enables screening a population of high risk, but asymptomatic, non-GERD individuals who account for the remaining 40% of EAC cases, but who fall totally outside of all current screening guidelines.

Conditions

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Barrett Esophagus Gastroesophageal Reflux Esophageal Adenocarcinoma

Keywords

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Esophagus Non-endoscopic

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

All endoscopic images will be reviewed by an examiner who will be blinded to the endoscopy report. BE will be defined as the presence of \> 1 cm of columnar appearing epithelium in the tubular esophagus as confirmed by the blinded reviewer plus the presence of intestinal metaplasia on biopsies. I

Study Groups

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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.

Group Type EXPERIMENTAL

EsoCheck

Intervention Type 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

Intervention Type DIAGNOSTIC_TEST

Approved laboratory, methylated DNA panel that detects esophageal neoplasia. The EsoGuard assay tests the EsoCheck samples to detect BE in GERD participants.

Interventions

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EsoCheck

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.

Intervention Type DEVICE

EsoGuard

Approved laboratory, methylated DNA panel that detects esophageal neoplasia. The EsoGuard assay tests the EsoCheck samples to detect BE in GERD participants.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

Patients undergoing screening colonoscopy are an accessible cohort for BE screening and are also a reasonable representation of the general population. Permission will be obtained from colonoscopy physicians for researchers to contact and recruit patients for this study. Patients without GERD, who are at risk for BE, and who have not had a prior EGD, will be recruited prior to or at the time of scheduled colonoscopy.(9) Those eligible will be:

* Adults who have not had prior EGD within past ten years, and are able to provide informed consent, and who have:
* No known coagulopathy, no known esophageal varices, not on chronic anticoagulation therapy, and have:
* No significant dysphagia or odynophagia; but who do have:
* Absence of GERD (absence of weekly heartburn or regurgitation, not on medications for GERD), and are:
* Adults \> age 50, who also have two or more added risk factors for BE from the set of: central obesity (waist size \> 35 inches for women and \> 40 inches for men), current smoker or smoking history \> 10 pack years, white race, male sex, confirmed history of BE/EAC in at least two family members, with one a first degree relative. While BE is most highly prevalent in white males, a black female over age 50 with obesity and a positive smoking history would also be at increased BE risk and would equally meet eligibility criteria.
* Subjects must have the ability to understand and the willingness to sign a written informed consent document.
* Subjects must have the ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria

* History of prior EGD procedure in past ten years
* 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 INR \> 1.5
* Known history of esophageal varices or esophageal stricture
* Any contraindication, as deemed in Investigator's medical judgment, to undergoing the EsoCheck procedure, undergoing the EGD procedure, 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 of uncomplicated surgical fundoplication procedure
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Case Comprehensive Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Amitabh Chak, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Locations

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University of Colorado

Aurora, Colorado, United States

Site Status RECRUITING

Johns Hopkins Hospital

Baltimore, Maryland, United States

Site Status NOT_YET_RECRUITING

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Site Status RECRUITING

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Site Status RECRUITING

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, United States

Site Status NOT_YET_RECRUITING

Countries

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United States

Central Contacts

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Wendy Brock

Role: CONTACT

Phone: 216-844-3853

Email: [email protected]

Facility Contacts

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Sachin Wani, MD

Role: primary

Marcia Canto, MD

Role: primary

Nicholas Shaheen, MD

Role: primary

Amitabh Chak, MD

Role: primary

[email protected]

Role: backup

Prashanti Thota, MD

Role: primary

Other Identifiers

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CASE10224

Identifier Type: -

Identifier Source: org_study_id