Non-Endoscopic Detection of Barrett's Esophagus Using Methylation Biomarkers on EndoSign® Cell Collection Device Samples
DETECT-ME
1 other identifier
observational
700
1 country
1
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a capsule, which dissolves in the stomach and releases a sponge that collects cells from the esophagus as the sponge is withdrawn using the thread.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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 22, 2025
CompletedFirst Posted
Study publicly available on registry
January 31, 2025
CompletedStudy Start
First participant enrolled
February 5, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
March 18, 2026
March 1, 2026
1.7 years
January 22, 2025
March 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Performance of Barrett's Esophagus Test (LDT) compared to standard of care.
Performance of the biomarker for detecting BE or confirming no BE in the study population including sensitivity, specificity, negative predictive value (NPV), and positive predictive value (PPV) on samples collected using the EndoSign Cell collection device as compared to endoscopy and pathology.
Sample collection prior to standard of care endoscopy
Secondary Outcomes (1)
Assess subject experience with the EndoSign Cell Collection Device
Through the end of the study-about 9 months
Other Outcomes (1)
Interim assessment of number of subjects with each diagnosis
Halfway through the study at about 4 months
Study Arms (2)
High Risk Screening without Barrett's Esophagus-closed 11/2025
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.
Barrett's Esophagus
Subjects with known Barrett's esophagus with or without dysplasia/cancer identified or confirmed (surveillance) via a standard of care endoscopy
Interventions
Barrett's Esophagus Test (LDT) will be performed on esophageal cells collected using the EndoSign Cell Collection Device (510(k) cleared) and compared to the results of standard of care EGD plus biopsies (if applicable)
Eligibility Criteria
Subjects scheduled for EGD (upper endoscopy) that meet the eligibility criteria at recruiting centers.
You may qualify if:
- 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.
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cyted Health Inclead
Study Sites (1)
Gastroenterology Practice
Cordova, Tennessee, 38138, United States
Biospecimen
DNA extracted from esophageal cells collected on the sponge.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Co-Lead Investigator
University of North Carolina
- PRINCIPAL INVESTIGATOR
Co-Lead Investigator
University of Colorado, Denver
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 22, 2025
First Posted
January 31, 2025
Study Start
February 5, 2025
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
March 18, 2026
Record last verified: 2026-03