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Genetic Determinants of Barrett's Esophagus and Esophageal Adenocarcinoma (FBE Trial)
Chapel Hill, NC
N/A
Recruiting
Led By Amitabh Chak, MD
Research Sponsored by Case Western Reserve University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 week
Awards & highlights
No Placebo-Only Group
Summary
This trial is focused on understanding the genetic susceptibility, genomic and epigenetic changes that influence the development of Barrett's esophagus (BE) and esophageal adenocarcinoma (ECA), and translating laboratory discoveries into clinical applications for effective detection, molecular risk stratification, and prevention of progression from BE to EAC.
See full description
Eligible Conditions
- Esophageal Neoplasms
- Barrett's Esophagus
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 week
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 week
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Assay of DNA and RNA markers
Secondary study objectives
Score of tolerability and acceptability
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Endoscopy
2019
Completed Phase 3
~3620
Find a Location
Closest Location:University of North Carolina at Chapel Hill· Chapel Hill, NC
Who is running the clinical trial?
University of North Carolina, Chapel HillOTHER
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4,315,720 Total Patients Enrolled
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VA Puget Sound Health Care SystemFED
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Case Western Reserve UniversityLead Sponsor
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