Non-Endoscopic Detection of Barrett's Esophagus Using Methylation Biomarkers on EndoSign® Cell Collection Device Samples (DETECT-ME)

Cyted Health Inc

Status: Enrolling

Conditions: Barrett Esophagus

Treatments: Device: Barrett's Esophagus Test (LDT)

Study type: Observational

Funder types: Industry

Identifiers

NCT06803927

ENDOEXT-28

Details and patient eligibility

About

This study is looking at cells collected from the esophagus using a diagnostic device called the EndoSign® Cell Collection Device (a sponge on a thread). Subjects swallow a capsule, which dissolves in the stomach and releases a sponge that collects cells from the esophagus as the sponge is withdrawn using the thread. These cells will be tested to check for a condition called "Barrett's Esophagus."

The cells from the sponge will be tested using Cyted Health biomarkers and compared to the results from a regular endoscopy and any biopsies that are taken. To do this, we need sponge samples from people who might have Barrett's Esophagus based on their risk factors, and from people with Barrett's Esophagus.

Subjects will have one visit to have the Endosign Cell Collection Device administered prior to having a standard of care endoscopy. They will answer some questions about their medical history and experience with the cell collection procedure as part of the study. Data will be collected from medical records including post-endoscopy.

Enrollment: 700 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

High Risk Screening Inclusion Criteria

• Undergoing a standard of care EGD
• Willing to undergo non-endoscopic sampling with the study device prior to EGD (up to 6 weeks prior to EGD or same day as EGD).
• Willing and able to sign informed consent
• Must have chronic GERD as defined in the ACG Guidelines
• Must have at least 3 additional risk factors as defined in the ACG guidelines such as:
• Age ≥ 50
• Family history of Barrett's esophagus or esophageal adenocarcinoma
• Current or former smoker
• Obesity (BMI greater than or equal to 30 kg/m2)
• Male
• Non-Hispanic White

Exclusion Criteria

• Previous EGD for BE, with no BE identified
• Known BE or EAC
• Current dysphagia (unable to swallow a pill the size of the capsule (8.5 mm diameter))
• Known or suspected gastric or esophageal varices
• Known or suspected portal hypertension
• Taking anti-thrombotic medications that cannot be discontinued
• Taking GLP-1 agonists that cannot be discontinued for 1 week prior to sponge administration
• Previous gastric or esophageal surgery (including Nissen fundoplication)
• History of oropharyngeal tumor
• History of myocardial infarction or cerebrovascular accident in past 6 months
• Known or suspected to be pregnant (self-report for women of child-bearing potential)

Barrett's Esophagus Inclusion Criteria

• Undergoing a standard of care EGD (with or without endoscopic eradication therapy {EET})
• Willing to undergo non-endoscopic sampling with the study device prior to EGD (up to 6 weeks prior to EGD/EET or day of EGD/EET).
• Willing and able to sign informed consent
• Confirmed Barrett's Esophagus of length at least 1 cm or greater. This includes non-dysplastic Barrett's, low-grade dysplasia, high-grade dysplasia or adenocarcinoma.

Exclusion Criteria

• Previous EGD result was indefinite for dysplasia
• Previous endoscopic eradication therapy (EET)
• Current dysphagia (unable to swallow a pill the size of the capsule (8.5 mm dia.))
• Known or suspected gastric or esophageal varices
• Known or suspected portal hypertension
• Taking anti-thrombotic medications that cannot be discontinued
• Taking GLP-1 agonists that cannot be discontinued for 1 week prior to sponge administration
• Previous gastric or esophageal surgery (including Nissen fundoplication)
• History of oropharyngeal tumor
• History of myocardial infarction or cerebrovascular accident in past 6 months
• Known or suspected to be pregnant (self-report for woman of child-bearing potential)

Trial design

700 participants in 2 patient groups

High Risk Screening without Barrett's Esophagus

Description:

Subjects with chronic GERD plus 3 other defined risk factors for Barrett's Esophagus (ACG) (e.g., age \>50, male, white, obese, family history) who have had a standard of care endoscopy in which no Barrett's esophagus was identified.

Treatment:

Device: Barrett's Esophagus Test (LDT)

Barrett's Esophagus

Description:

Subjects with known Barrett's esophagus with or without dysplasia/cancer identified or confirmed (surveillance) via a standard of care endoscopy

Treatment:

Device: Barrett's Esophagus Test (LDT)