Genetic Research for Barrett's Esophagus and Esophageal Cancer
(FBE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial investigates how genetics might influence Barrett's esophagus (BE) and esophageal adenocarcinoma (EAC) to improve detection, prevention, and treatment. Participants will undergo endoscopy, a procedure that allows doctors to examine the esophagus. Ideal candidates include individuals with confirmed Barrett's esophagus or esophageal cancer, or their family members. The researchers aim to translate genetic findings into better management strategies for BE and prevent its progression to EAC. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could significantly advance the management and prevention of these conditions.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that endoscopy is safe for Barrett's esophagus and esophageal adenocarcinoma patients?
Research has shown that endoscopy, a procedure to look inside the body, is generally safe and well-tolerated for diagnosing conditions like Barrett's esophagus and esophageal cancer. Studies have found that endoscopy effectively detects early-stage esophageal cancer, which is crucial for successful treatment.
Endoscopy has a strong safety record. Clinical guidelines recommend it for early detection of esophageal issues because it helps reduce the risk of dying from esophageal cancer. Additionally, transnasal endoscopy, a type of endoscopy, is not only safe but also more comfortable for patients compared to traditional methods.
Overall, evidence suggests that endoscopy is a reliable and safe option for screening individuals for Barrett's esophagus or related conditions.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it aims to uncover the genetic factors that contribute to Barrett's Esophagus (BE) and Esophageal Adenocarcinoma (EAC). Unlike standard treatments, which usually focus on managing symptoms or surgically addressing these conditions, this trial focuses on understanding genetic predispositions. By identifying genetic markers, the study hopes to improve early detection and personalize treatment strategies. This could lead to more targeted interventions and potentially prevent the progression of BE to cancer, offering a significant advancement over current approaches that primarily treat existing disease.
What evidence suggests that endoscopy is effective for Barrett's esophagus and esophageal adenocarcinoma?
Research has shown that endoscopy effectively detects Barrett's esophagus (BE) and esophageal adenocarcinoma (EAC) early. In this trial, participants will be divided into groups: those undergoing surveillance for BE or EAC, those scheduled for EGD screening for GERD, those scheduled for colonoscopy who meet criteria for BE screening, and controls who do not meet screening criteria. Studies indicate that endoscopic screening can detect esophageal changes before they become more serious, allowing doctors to monitor and treat patients sooner. Endoscopic treatments for BE have also demonstrated good results over time, helping to prevent cancer development. These findings support endoscopy as a valuable tool for detecting and managing BE and EAC.12467
Who Is on the Research Team?
Amitabh Chak, MD
Principal Investigator
University Hospitals Cleveland Medical Center, CWRU, Cleveland, OH
Gary W Falk, MD, MS
Principal Investigator
University of Pennsylvania
William Grady, MD
Principal Investigator
Fred Hutchinson Cancer Research Center, UWMC, Seattle, WA
Nicholas J Shaheen, M.D.
Principal Investigator
University of North Carolina, Chapel Hill
Ganapathy Prasad, M.D.
Principal Investigator
Mayo Clinic
Marcia Canto, M.D.
Principal Investigator
Johns Hopkins University
John Dumont, D.O.
Principal Investigator
University Hospitals Cleveland Medical Center
Prashanthi Thota, M.D.
Principal Investigator
The Cleveland Clinic
Jean Wang, MD
Principal Investigator
Washington University School of Medicine
Julian Abrams, MD
Principal Investigator
Columbia University
Andrew Kaz, MD
Principal Investigator
VA Puget Sound Health Care System
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Esophageal Sampling
Participants undergo non-endoscopic balloon sampling and standard EGD for biospecimen collection
Treatment/Surveillance
Patients with BE or EAC undergo standard of care surveillance and diagnostic biopsies
Follow-up
Participants are monitored for safety and effectiveness after esophageal sampling
What Are the Treatments Tested in This Trial?
Interventions
- Endoscopy
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Patients scheduled for clinically indicated EGD for GERD who meet ACG criteria for BE screening
Patients scheduled for EGD who do not meet criteria for screening
Patients scheduled for screening colonoscopy who have not had EGD and meet clinically indicated criteria for BE screening
Patients with Barrett's esophagus undergoing surveillance or patients with esophageal adenocarcinoma and esophagogastric junctional adenocarcinoma undergoing EGD
Endoscopy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:
- Diagnostic purposes for various gastrointestinal conditions including rectal cancer
- Diagnostic purposes for various gastrointestinal conditions including rectal cancer
- Diagnostic purposes for various gastrointestinal conditions including rectal cancer
- Diagnostic purposes for various gastrointestinal conditions including rectal cancer
- Diagnostic purposes for various gastrointestinal conditions including rectal cancer
- Diagnostic purposes for various gastrointestinal conditions including rectal cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
Case Western Reserve University
Lead Sponsor
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
University Hospitals Cleveland Medical Center
Collaborator
Washington University School of Medicine
Collaborator
Fred Hutchinson Cancer Center
Collaborator
University of Washington
Collaborator
Citations
May 2025
EFFICACY AND SAFETY OF ENDOSCOPIC TREATMENT FOR BARRETT'S ESOPHAGUS ... CLINICAL BACKGROUND AND OUTCOMES OVER TIME OF PATIENTS WITH BARRETT'S ...
Review Advances in Screening for Barrett Esophagus and ...
In this review, we aim to provide a comprehensive review of recent innovations in the nonendoscopic detection of BE and EAC.
Endoscopic diagnosis and screening of Barrett's esophagus
We present a review of the endoscopic diagnosis and screening of BE, focusing on the inconsistency of diagnostic criteria, especially between Japan and Western ...
Endoscopic Screening for Barrett's Esophagus and ...
Endoscopic screening and surveillance are performed to identify patients earlier in the metaplasia-dysplasia-carcinoma sequence from BE to EAC followed by ...
Advances in Screening for Barrett Esophagus and ...
In this review, we aim to provide a comprehensive review of recent innovations in the nonendoscopic detection of BE and EAC.
AGA Clinical Practice Guideline on Surveillance of Barrett's ...
Endoscopic surveillance has been proposed for early detection of BE-related neoplasia and reducing EAC mortality. This clinical practice guideline aims to ...
Barrett's esophagus screening: Current modalities, risk ...
Transnasal endoscopy has shown comparable diagnostic yield to EGD for BE detection [46], and is considered safe and better tolerated than EGD, with a ...
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