Massively Parallel Sequencing of Esophageal Brushings Enables an Aneuploidy-Based Classification of Patients With Barrett's Esophagus.
Christopher Douville, Helen R Moinova, Prashanthi N Thota...
https://pubmed.ncbi.nlm.nih.gov/33493502Actively Recruiting
Age: 18Years +
All Genders
Healthy Volunteers
ID00288119
Genetic and Environmental Determinants of Barrett's Esophagus and Esophageal Adenocarcinoma
Led by Case Western Reserve University · Updated on 2025-07-18
2000
Participants Needed
10
Research Sites
N/A
Total Duration
On this page
Sponsors
C
Case Western Reserve University
Lead Sponsor
U
University Hospitals Cleveland Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying Barrett's esophagus (BE) and esophageal adenocarcinoma (EAC) to better understand their genetic and environmental causes. The study aims to improve detection, prevention, and treatment by exploring genetic, epigenetic, and transcriptome changes. This research combines laboratory findings with clinical applications to help prevent EAC and improve patient outcomes through a collaborative, multi-institutional approach. Participants will undergo esophageal sampling using a non-endoscopic balloon capsule device that collects tissue from the esophagus for genetic analysis. This is combined with a standard upper endoscopy (EGD) to visually examine the upper digestive system and collect biopsies. Samples from different parts of the esophagus and stomach will be stored for DNA and RNA testing. The balloon capsule is swallowed, inflated in the stomach, and gently pulled back to collect tissue before being removed. During the study, participants will have their biospecimens collected and frozen for later analysis. Patients with BE or EAC will receive standard care, including surveillance and diagnostic biopsies. Researchers will assess DNA and RNA markers within one week and evaluate participant comfort immediately after the procedure. The study includes various patient groups undergoing EGD for surveillance, screening, or other clinical reasons. Participation involves genetic testing and questionnaires about procedure tolerability, with ongoing monitoring planned through 2028.
CONDITIONS
Brief Title
Genetic Determinants of Barrett's Esophagus and Esophageal Adenocarcinoma
Who Can Participate
Age: 18Years +
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Diagnosis of Barrett's esophagus confirmed by pathology and endoscopy report, or adenocarcinoma of the esophagus, or being a family member of a person with Barrett's esophagus or esophageal adenocarcinoma
- Male or female aged 18 years or older at the time of enrollment
- Male or female under 18 years of age at enrollment with parental consent
- Ability to give informed consent if 18 years or older
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - 1 day
Participants undergo esophageal sampling using a non-endoscopic balloon capsule device and an upper endoscopy (EGD) to collect tissue and brushings for genetic and environmental research related to Barrett's esophagus and esophageal adenocarcinoma.
1 procedure visit (in-person)
Long-term Monitoring
Duration - Up to several years as per clinical care
Participants with Barrett's esophagus or esophageal adenocarcinoma have standard of care surveillance with diagnostic biopsies and research samples collected during follow-up EGDs.
Periodic visits depending on clinical surveillance schedule
Trial Site Locations
Total: 10 locations
1
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21205
Actively Recruiting
2
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
3
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
4
Columbia University Medical Center
New York, New York, United States, 10032
Actively Recruiting
5
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
6
University Hospitals of Cleveland
Cleveland, Ohio, United States, 44106-8066
Actively Recruiting
7
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
8
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
9
VA Puget Sound Health Care System
Seattle, Washington, United States, 98108
Actively Recruiting
10
Fred Hutchinson Cancer Research Center, UWMC
Seattle, Washington, United States, 98109
Actively Recruiting
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Research Team
A
Amitabh Chak, MD
W
Wendy Brock, RN
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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Published Research Related To This Trial
Multicenter, Prospective Trial of Nonendoscopic Biomarker-Driven Detection of Barrett's Esophagus and Esophageal Adenocarcinoma.
Helen R Moinova, Suman Verma, John Dumot...
https://pubmed.ncbi.nlm.nih.gov/38686933Variation in age at cancer diagnosis in familial versus nonfamilial Barrett's esophagus.
Amitabh Chak, Yanwen Chen, Jaime Vengoechea...
https://pubmed.ncbi.nlm.nih.gov/22178570