RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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capsule, which dissolves in the stomach and releases a sponge that collects cells from the esophagus as the sponge is withdrawn using the thread.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

Official Title

Non-Endoscopic Detection of Barrett's Esophagus and Esophageal Neoplasia Using Methylation Biomarkers on Endosign® Cell Collection Device Samples

Quick Facts

Study Start:2025-02-05
Study Completion:2025-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06803927

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Melissa Tuck, M.S.
CONTACT
734-358-0587
m.tuck@cytedhealth.com
Keith Fiman, M.D.
CONTACT
713-305-1074
k.fiman@cytedhealth.com

Principal Investigator

Co-Lead Investigator
PRINCIPAL_INVESTIGATOR
University of North Carolina
Co-Lead Investigator
PRINCIPAL_INVESTIGATOR
University of Colorado, Denver

Study Locations (Sites)

Gastroenterology Practice
Cordova, Tennessee, 38138
United States

Collaborators and Investigators

Sponsor: Cyted Health Inc

  • Co-Lead Investigator, PRINCIPAL_INVESTIGATOR, University of North Carolina
  • Co-Lead Investigator, PRINCIPAL_INVESTIGATOR, University of Colorado, Denver

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-05
Study Completion Date2025-10

Study Record Updates

Study Start Date2025-02-05
Study Completion Date2025-10

Terms related to this study

Keywords Provided by Researchers

  • Endosign® Cell Collection Device
  • Barretts Esophagus

Additional Relevant MeSH Terms

  • Barrett Esophagus