Clinical trial NCT06803927: Non-Endoscopic Detection of Barrett's Esophagus Using Methylation Biomarkers on EndoSign® Cell Collection Device Samples
Official title: Non-Endoscopic Detection of Barrett's Esophagus and Esophageal Neoplasia Using Methylation Biomarkers on Endosign® Cell Collection Device Samples
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Barrett Esophagus
Keywords: Endosign® Cell Collection Device
Barretts Esophagus
Lead sponsor: Cyted Health Inc
Sponsor class: INDUSTRY
First posted: 2025-01-31
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects scheduled for EGD (upper endoscopy) that meet the eligibility criteria at recruiting centers.

Brief summary: 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a capsule, which dissolves in the stomach and releases a sponge that collects cells from the esophagus as the sponge is withdrawn using the thread.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.


Eligibility 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)

Primary outcomes:
measure: Performance of Barrett's Esophagus Test (LDT) compared to standard of care.
timeFrame: Sample collection prior to standard of care endoscopy
Secondary outcomes:
measure: Assess subject experience with the EndoSign Cell Collection Device
timeFrame: Through the end of the study-about 9 months
Other outcomes:
measure: Interim assessment of number of subjects with each diagnosis
timeFrame: Halfway through the study at about 4 months
Locations:
city: Cordova
country: United States
facility: Gastroenterology Practice
state: Tennessee
Study officials:
affiliation: University of North Carolina
name: Co-Lead Investigator
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Colorado, Denver
name: Co-Lead Investigator
role: PRINCIPAL_INVESTIGATOR
References: