2000 Participants Needed

Genetic Determinants of Barrett's Esophagus and Esophageal Adenocarcinoma

(FBE Trial)

Recruiting at 9 trial locations
AC
WB
Overseen ByWendy Brock, RN
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Case Western Reserve University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 6 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

AC

Amitabh Chak, MD

Principal Investigator

University Hospitals Cleveland Medical Center, CWRU, Cleveland, OH

GW

Gary W Falk, MD, MS

Principal Investigator

University of Pennsylvania

WG

William Grady, MD

Principal Investigator

Fred Hutchinson Cancer Research Center, UWMC, Seattle, WA

NJ

Nicholas J Shaheen, M.D.

Principal Investigator

University of North Carolina, Chapel Hill

GP

Ganapathy Prasad, M.D.

Principal Investigator

Mayo Clinic

MC

Marcia Canto, M.D.

Principal Investigator

Johns Hopkins University

JD

John Dumont, D.O.

Principal Investigator

University Hospitals Cleveland Medical Center

PT

Prashanthi Thota, M.D.

Principal Investigator

The Cleveland Clinic

JW

Jean Wang, MD

Principal Investigator

Washington University School of Medicine

JA

Julian Abrams, MD

Principal Investigator

Columbia University

AK

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?
4Treatment groups
Experimental Treatment
Group I: EGD ScreeningExperimental Treatment2 Interventions
Patients scheduled for clinically indicated EGD for GERD who meet ACG criteria for BE screening
Group II: ControlsExperimental Treatment2 Interventions
Patients scheduled for EGD who do not meet criteria for screening
Group III: Colon ScreeningExperimental Treatment2 Interventions
Patients scheduled for screening colonoscopy who have not had EGD and meet clinically indicated criteria for BE screening
Group IV: CasesExperimental Treatment2 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

Find a Clinic Near You

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+
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