About this trial
The overall objectives of this BETRNet Research Center (RC) are:
1. to conduct a rigorous, integrated spectrum of transdisciplinary human research in Barrett's esophagus (BE) and esophageal adenocarcinoma (ECA) 2. to increase the biological understanding of key observations made by our clinical researchers; 3. to translate knowledge derived from genetic, epigenetic, and transcriptome research to solving clinical dilemmas in detection, prognosis, prevention, and therapy of BE in order to prevent EAC and improve the outcomes of EAC; 4. to foster a transdisciplinary and translation research culture and to effectively expand and enhance scientific research focused on BE and EAC; 5. to evaluate research and transdisciplinary programs and to continuously improve research, productivity and enhance translational implementation. These objectives build and synergize on existing multi-institutional collaborative networks and the considerable clinical, basic science, and translational expertise available at our institutions, focusing on improving the outcomes of patients with BE and EAC. The overarching organization framework for this RC proposal is 1) to focus laboratory research on understanding the genetic susceptibility, genomic and epigenetic changes that influence the development of BE and EAC; and 2) to then translate laboratorydiscoveries into clinical applications for effective detection, molecular risk stratification, and prevention of progression from BE to EAC.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Barrett's esophagus confirmed by review of pathology and endoscopy report or adenocarcinoma of the esophagus or family members of person with Barrett's esophagus or adenocarcinoma of the esophagus.
Male or female age 18 or older at time of enrollment or male or female less than 18 years of age at time of enrollment with parental consent.
Ability to give informed consent, if patient is age 18 or older.
Disqualifiers
None
Trial population
Individuals with Barrett's esophagus or adenocarcenoma of the esophagus whose medical care is at the participating institutions, are referred from outside institutions, or who contact the participating institutions.
Trial design
Case-control
Cross-sectional
Treatments tested in this trial
Balloon Capsule Device
DeviceThe Esophageal Sampling Device BESD-001 is a non-endoscopic balloon capsule catheter for obtaining an esophageal mucosal sample. At the distal end of the catheter there is a silicone capsule textured balloon assembly. The textured balloon is initially inverted with vacuum for patient to swallow the capsule but then is inflated with 5.6 cc of air (5 cc syringe withdrawn maximally) to a 16-18 mm diameter in order to contact the lumen of the esophagus to collect a sample. The balloon has a textured surface, which enhances the collection of the esophageal sample. Following sample collection the textured balloon is inverted back into the hollow capsule component via syringe draw vacuum in order to maximize \& protect the site-specific sample collection.
Endoscopy
Procedure/SurgeryAn upper endoscopy is a procedure used to visually examine your upper digestive system with a tiny camera on the end of a long, flexible tube.
Treatment groups
Trial outcomes
Primary outcomes
Assay of DNA and RNA markers
The Balloon tip is collected and sent to the PacificDx Laboratory in Irvine California to test for DNA extraction
Secondary outcomes
Score of tolerability and acceptability
6 item scale rating scale using scale of 1-10 where 1 is no worries to 10 being severe to rate Tolerability; and a 3 item scale rating the acceptability of Balloon Capsule Device using strongly agree to strongly disagree rating
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Case Western Reserve University
Lead sponsor
University Hospitals Cleveland Medical Center
Collaborator
Washington University School of Medicine
Collaborator
Fred Hutchinson Cancer Center
Collaborator
University of Washington
Collaborator
Mercy Medical Center
Collaborator
Johns Hopkins University
Collaborator
Mayo Clinic
Collaborator
University of North Carolina, Chapel Hill
Collaborator
The Cleveland Clinic
Collaborator
University of Pennsylvania
Collaborator
Columbia University
Collaborator
VA Puget Sound Health Care System
Collaborator