Genetic Determinants of Barrett's Esophagus and Esophageal Adenocarcinoma

NCT00288119 | Recruiting DMC FDA Device

• 2 other identifiers: R01DK070863NIH IK24DK02800
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 10

Brief Summary

The overall objectives of this BETRNet Research Center (RC) are:

1. 1.to conduct a rigorous, integrated spectrum of transdisciplinary human research in Barrett's esophagus (BE) and esophageal adenocarcinoma (ECA)
2. 2.to increase the biological understanding of key observations made by our clinical researchers;
3. 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. 4.to foster a transdisciplinary and translation research culture and to effectively expand and enhance scientific research focused on BE and EAC;
5. 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

Keywords

Barrett's Esophagus

Outcome Measures

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

  1 week

Secondary Outcomes (1)

• Score of tolerability and acceptability

  1 minute after procedure

Study Arms (4)

Cases

Patients with Barrett's esophagus undergoing surveillance or patients with esophageal adenocarcinoma and esophagogastric junctional adenocarcinoma undergoing EGD

Device: Balloon Capsule Device; Procedure: Endoscopy

EGD Screening

Patients scheduled for clinically indicated EGD for GERD who meet ACG criteria for BE screening

Device: Balloon Capsule Device; Procedure: Endoscopy

Colon Screening

Patients scheduled for screening colonoscopy who have not had EGD and meet clinically indicated criteria for BE screening

Device: Balloon Capsule Device; Procedure: Endoscopy

Controls

Patients scheduled for EGD who do not meet criteria for screening

Device: Balloon Capsule Device; Procedure: Endoscopy

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.

Also known as: Esophageal Sampling Device BESD-001

Cases; Colon Screening; Controls; EGD Screening

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.

Also known as: EGD

Cases; Colon Screening; Controls; EGD Screening

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

Eligible cases will be defined as those patients and their family members who meet the following criteria: * 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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Case Western Reserve University: lead
• 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

Study Sites (10)

Johns Hopkins Hospital

Baltimore, Maryland, 21205, United States

RECRUITING

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

Washington University School of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

Columbia University Medical Center

New York, New York, 10032, United States

RECRUITING

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

RECRUITING

University Hospitals of Cleveland

Cleveland, Ohio, 44106-8066, United States

RECRUITING

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

VA Puget Sound Health Care System

Seattle, Washington, 98108, United States

RECRUITING

Fred Hutchinson Cancer Research Center, UWMC

Seattle, Washington, 98109, United States

RECRUITING

Related Publications (3)

• Douville C, Moinova HR, Thota PN, Shaheen NJ, Iyer PG, Canto MI, Wang JS, Dumot JA, Faulx A, Kinzler KW, Papadopoulos N, Vogelstein B, Markowitz SD, Bettegowda C, Willis JE, Chak A. Massively Parallel Sequencing of Esophageal Brushings Enables an Aneuploidy-Based Classification of Patients With Barrett's Esophagus. Gastroenterology. 2021 May;160(6):2043-2054.e2. doi: 10.1053/j.gastro.2021.01.209. Epub 2021 Jan 22.

  PMID: 33493502 BACKGROUND

• Moinova HR, Verma S, Dumot J, Faulx A, Iyer PG, Canto MI, Wang JS, Shaheen NJ, Thota PN, Aklog L, Willis JE, Markowitz SD, Chak A. Multicenter, Prospective Trial of Nonendoscopic Biomarker-Driven Detection of Barrett's Esophagus and Esophageal Adenocarcinoma. Am J Gastroenterol. 2024 Nov 1;119(11):2206-2214. doi: 10.14309/ajg.0000000000002850. Epub 2024 Apr 30.

  PMID: 38686933 DERIVED

• Chak A, Chen Y, Vengoechea J, Canto MI, Elston R, Falk GW, Grady WM, Guda K, Kinnard M, Markowitz S, Mittal S, Prasad G, Shaheen N, Willis JE, Barnholtz-Sloan JS. Variation in age at cancer diagnosis in familial versus nonfamilial Barrett's esophagus. Cancer Epidemiol Biomarkers Prev. 2012 Feb;21(2):376-83. doi: 10.1158/1055-9965.EPI-11-0927. Epub 2011 Dec 16.

  PMID: 22178570 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood Samples from + families with 3 or members diagnosed with BE or ECA will be sent to our NIH approved Biorepository and this repository is designed to help all researchers performing studies on the genetic basis of diseases. Biospecimens, brushings and biopsies, will be obtained via snap frozen at bedside and stored for future research assays at Case Western Reserve Biorepository. Balloon Capsule Device Tips are sent to the University Hospitals Transnational Laboratory in Cleveland. The tips are processed for process of assay of DNA and RNA.

MeSH Terms

Conditions

Barrett Esophagus; Esophageal Neoplasms

Interventions

Endoscopy

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Amitabh Chak, MD

  University Hospitals Cleveland Medical Center, CWRU, Cleveland, OH

  PRINCIPAL INVESTIGATOR

• Gary W Falk, MD, MS

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• William Grady, MD

  Fred Hutchinson Cancer Research Center, UWMC, Seattle, WA

  PRINCIPAL INVESTIGATOR

• Nicholas J Shaheen, M.D.

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

• Ganapathy Prasad, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

• Marcia Canto, M.D.

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

• John Dumont, D.O.

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

• Prashanthi Thota, M.D.

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

• Jean Wang, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

• Julian Abrams, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

• Andrew Kaz, MD

  VA Puget Sound Health Care System

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amitabh Chak, MD

CONTACT

216-844-5385; axc22@po.cwru.edu

Wendy Brock, RN

CONTACT

216-844-3853; wendy.brock@UHhospitals.org

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2006
• First Posted: February 7, 2006
• Study Start: October 1, 2005
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): July 31, 2028
• Last Updated: July 18, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)