Genetic Determinants of Barrett's Esophagus and Esophageal Adenocarcinoma

Conditions

• Barrett's Esophagus
• Esophageal Neoplasm

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Accepted

Interventions

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inverted with vacuum for patient to swallow the capsule but then is inflated with 5.6 cc of air (5 cc syringe withdrawn maximally) to a 16-18 mm diameter in order to contact the lumen of the esophagus to collect a sample.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

Study Details

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.

Key Dates

Start date

Oct 1, 2005

Status verified

Jul 2025

Primary completion

Jul 31, 2028

Completion

Jul 31, 2028

Study Design

Enrollment

2,000 participants (estimated)

Arms

• Arm: Cases
  Patients with Barrett's esophagus undergoing surveillance or patients with esophageal adenocarcinoma and esophagogastric junctional adenocarcinoma undergoing EGD
• Arm: EGD Screening
  Patients scheduled for clinically indicated EGD for GERD who meet ACG criteria for BE screening
• Arm: Colon Screening
  Patients scheduled for screening colonoscopy who have not had EGD and meet clinically indicated criteria for BE screening
• Arm: Controls
  Patients scheduled for EGD who do not meet criteria for screening

Primary Outcome Measure

Assay of DNA and RNA markers [ Time Frame: 1 week ]

Central Contacts

• Amitabh Chak, MD
  216-844-5385
  [email protected]
• Wendy Brock, RN
  216-844-3853
  [email protected]

Locations (10)

Find similar trials in Baltimore, MD

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