Genetic Determinants of Barrett's Esophagus and Esophageal Adenocarcinoma

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCase Western Reserve University

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 volunteers

Qualifiers

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

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

  • Balloon Capsule Device

    Device

    The 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/Surgery

    An 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

2,000 Participants
are divided into 4 treatment groups
Group A: Cases2 interventions
Group B: EGD Screening2 interventions
Group C: Colon Screening2 interventions
Group D: Controls2 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
1 week

Secondary outcomes

1

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

Time frame
1 minute after procedure

Other outcomes

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