Genetic Determinants of Barrett's Esophagus and Esophageal Adenocarcinoma

Summary

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.

Conditions

• Barrett's Esophagus
• Esophageal Neoplasm

Interventions

DEVICE

Balloon Capsule 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initially inverted with vacuum for patient to swallow the capsule but then is inflated with 5.6 cc of air (5 cc syringe withdrawn maximally) to a 16-18 mm diameter in order to contact the lumen of the esophagus to collect a sample.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.

PROCEDURE

Endoscopy

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.

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center

  collaborator OTHER

• Washington University School of Medicine

  collaborator OTHER

• Fred Hutchinson Cancer Center

  collaborator OTHER

• University of Washington

  collaborator OTHER

• Mercy Medical Center

  collaborator OTHER

• Johns Hopkins University

  collaborator OTHER

• Mayo Clinic

  collaborator OTHER

• University of North Carolina, Chapel Hill

  collaborator OTHER

• The Cleveland Clinic

  collaborator OTHER

• University of Pennsylvania

  collaborator OTHER

• Columbia University

  collaborator OTHER

• VA Puget Sound Health Care System

  collaborator FED

• Case Western Reserve University

  lead OTHER

Principal Investigators

• Amitabh Chak, MD · University Hospitals Cleveland Medical Center, CWRU, Cleveland, OH

• Gary W Falk, MD, MS · University of Pennsylvania

• William Grady, MD · Fred Hutchinson Cancer Research Center, UWMC, Seattle, WA

• Nicholas J Shaheen, M.D. · University of North Carolina, Chapel Hill

• Ganapathy Prasad, M.D. · Mayo Clinic

• Marcia Canto, M.D. · Johns Hopkins University

• John Dumont, D.O. · University Hospitals Cleveland Medical Center

• Prashanthi Thota, M.D. · The Cleveland Clinic

• Jean Wang, MD · Washington University School of Medicine

• Julian Abrams, MD · Columbia University

• Andrew Kaz, MD · VA Puget Sound Health Care System

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2005-10-01

Primary Completion

2028-07-31

Completion

2028-07-31

FDA Device

Yes

Countries

• United States

Study Locations