Recruiting

Genetic Determinants

Sponsor:

Case Western Reserve University

Code:

NCT00288119

Conditions

Barrett's Esophagus

Esophageal Neoplasm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Balloon Capsule Device

Endoscopy

Study Details

Brief 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

Study ID

NCT00288119

Start date

Oct 1, 2005

Status verified date

Aug, 2026

Completion date

Jul 31, 2028

Anticipated

Primary completion date

Jul 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

2000 participants

Anticipated

Interventions and Outcome Measures

Arms

Cases

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

EGD Screening

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

Colon Screening

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

Controls

Patients scheduled for EGD who do not meet criteria for screening

Interventions

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.

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Amitabh Chak, MD

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

Wendy Brock, RN

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

Locations

Johns Hopkins Hospital

Recruiting

Baltimore, Maryland, United States, 21205

Contacts

Marcia Canto, M.D.

(410) 614-5388

Hilary Cosby, RN

(410) 502-2893Hcosby1@jhmi.edu

Principal Investigator:

Marcia I Canto, M.D.

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Ganapathy A Prasad, M.D.

(507) 255-6930Prasad.Ganapathy@Mayo.edu

Ramona Lansing

507-538-4974lansing.ramona@mayo.edu

Principal Investigator:

Ganapathy A Prasad, M.D.

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Jean Wang, MD

314-362-5952jwang@DOM.wustl.edu

Thomas Hollander

314-747-1973tholland@DOM.wustl.edu

Principal Investigator:

Jean Wang, MD

Columbia University Medical Center

Recruiting

New York, New York, United States, 10032

Contacts

Julian Abrams, MD

212-342-0476ja660@mail.cumc.columbia.edu

Adriana Rodriquez

212-304-5606

Principal Investigator:

Julian Abrams, MD

University of North Carolina at Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Nicholas J Shaheen, M.D.

919-966-2513nshaheen@med.unc.edu

Alondra Santiago

(919) 843-8571alondra_santiago@med.unc.edu

Principal Investigator:

Nicholas J Shaheen, M.D.

University Hospitals of Cleveland

Recruiting

Cleveland, Ohio, United States, 44106-8066

Contacts

Amitabh Chak, MD

216-844-5386axc22@po.cwru.edu

Wendy Brock, RN

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

Principal Investigator:

Amitabh Chak, MD

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Prashanthi Thota, MD

216-444-0780THOTAP@ccf.org

Vidhi Patel, MD

(216) 444-0780VPatel@ccf.org

Principal Investigator:

Prashanthi Thota, MD

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Gary W Falk, MD, MS

215-615-6588Gary.Falk@uphs.upenn.edu

Maureen Demarshall, RN

215-349-8546demarchm@mail.upenn.edu

Principal Investigator:

Gary W. Falk, MD, MS

VA Puget Sound Health Care System

Recruiting

Seattle, Washington, United States, 98108

Contacts

Julie LaGuire

206-277-6662julie.laguire@VA.gov

Fred Hutchinson Cancer Research Center, UWMC

Recruiting

Seattle, Washington, United States, 98109

Contacts

William Grady, MD

206-667-1107wgrady@fhcrc.org

Wynn Burke

WBurke@medicine.washington.edu

Principal Investigator:

William Grady, MD

More Information

Sponsor

Case Western Reserve University

Last update posted

Aug 10, 2026

Last verified

Aug, 2026

Keywords

  • Barrett's Esophagus

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Case Western Reserve University on 2026-08-10.