RecruitingNCT00288119

Genetic Determinants of Barrett's Esophagus and Esophageal Adenocarcinoma

Genetic and Environmental Determinants of Barrett's Esophagus and Esophageal Adenocarcinoma


Sponsor

Case Western Reserve University

Enrollment

2,000 participants

Start Date

Oct 1, 2005

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is trying to find genetic and environmental factors that explain why some people with chronic acid reflux develop Barrett's esophagus (a pre-cancerous change in the food pipe) or esophageal cancer, while others do not. **You may be eligible if...** - You have been diagnosed with Barrett's esophagus or esophageal cancer - You have chronic acid reflux (GERD) and are willing to participate as a comparison subject - You are willing to provide a blood or saliva sample and answer health questionnaires **You may NOT be eligible if...** - You are under 18 years old - You are unable to provide informed consent - You have had certain esophageal surgeries that would affect the study data Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEBalloon 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.

PROCEDUREEndoscopy

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.


Locations(10)

Johns Hopkins Hospital

Baltimore, Maryland, United States

Mayo Clinic

Rochester, Minnesota, United States

Washington University School of Medicine

St Louis, Missouri, United States

Columbia University Medical Center

New York, New York, United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

University Hospitals of Cleveland

Cleveland, Ohio, United States

Cleveland Clinic

Cleveland, Ohio, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

VA Puget Sound Health Care System

Seattle, Washington, United States

Fred Hutchinson Cancer Research Center, UWMC

Seattle, Washington, United States

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NCT00288119


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