Genetic Research for Barrett's Esophagus and Esophageal Cancer

(FBE Trial)

Recruiting at 10 trial locations

Overseen By Wendy Brock, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Case Western Reserve University

Disqualifiers: None

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

2000 Participants Needed

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. ^{1 2 3 4 5}

Why 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. ^{1 2 4 6 7}

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

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.

Ability to give informed consent, if patient is age 18 or older

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Esophageal Sampling

Participants undergo non-endoscopic balloon sampling and standard EGD for biospecimen collection

1 week

1 visit (in-person)

Treatment/Surveillance

Patients with BE or EAC undergo standard of care surveillance and diagnostic biopsies

Ongoing

Follow-up

Participants are monitored for safety and effectiveness after esophageal sampling

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Endoscopy

How Is the Trial Designed?

Group I: EGD Screening Experimental Treatment 2 Interventions

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

Group II: Controls Experimental Treatment 2 Interventions

Patients scheduled for EGD who do not meet criteria for screening

Group III: Colon Screening Experimental Treatment 2 Interventions

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

Group IV: Cases Experimental Treatment 2 Interventions

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:

Approved in European Union as Endoscopy for:

• Diagnostic purposes for various gastrointestinal conditions including rectal cancer

Approved in United States as Endoscopy for:

• Diagnostic purposes for various gastrointestinal conditions including rectal cancer

Approved in Canada as Endoscopy for:

• Diagnostic purposes for various gastrointestinal conditions including rectal cancer

Approved in Japan as Endoscopy for:

• Diagnostic purposes for various gastrointestinal conditions including rectal cancer

Approved in China as Endoscopy for:

• Diagnostic purposes for various gastrointestinal conditions including rectal cancer

Approved in Switzerland as Endoscopy for:

• Diagnostic purposes for various gastrointestinal conditions including rectal cancer

Who Is Running the Clinical Trial?

Case Western Reserve University

Lead Sponsor

Trials

314

Recruited

236,000+

University of North Carolina, Chapel Hill

Collaborator

Trials

1,588

Recruited

4,364,000+

The Cleveland Clinic

Collaborator

Trials

1,072

Recruited

1,377,000+

University of Pennsylvania

Collaborator

Trials

2,118

Recruited

45,270,000+

Columbia University

Collaborator

Trials

1,529

Recruited

2,832,000+

VA Puget Sound Health Care System

Collaborator

Trials

67

Recruited

225,000+

University Hospitals Cleveland Medical Center

Collaborator

Trials

348

Recruited

394,000+

Washington University School of Medicine

Collaborator

Trials

2,027

Recruited

2,353,000+

Fred Hutchinson Cancer Center

Collaborator

Trials

583

Recruited

1,341,000+

University of Washington

Collaborator

Trials

1,858

Recruited

2,023,000+

Citations

1. giejournal.org giejournal.org/issue/S0016-5107(25)X0005-5?pageStart=15

May 2025 EFFICACY AND SAFETY OF ENDOSCOPIC TREATMENT FOR BARRETT'S ESOPHAGUS ... CLINICAL BACKGROUND AND OUTCOMES OVER TIME OF PATIENTS WITH BARRETT'S ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0025619623003488

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.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8828243/

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 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8127641/

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 ...

5. mayoclinicproceedings.org mayoclinicproceedings.org/article/S0025-6196(23)00348-8/fulltext

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.

6. gastrojournal.org gastrojournal.org/article/S0016-5085(25)06013-5/abstract

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 ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1521691825000162

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 ...