Genetic Determinants of Barrett's Esophagus and Esophageal Adenocarcinoma

Study acronym: FBE
StatusRecruiting
PhaseNot specified
Started

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Record History

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  1. Minor Site contacts updated at 2 of 10 sitesv26
  2. 2 versions Re-verified since May 20, 2025, no change to tracked fieldsv24-v25
  3. Notable Lead sponsor: University Hospitals Cleveland Medical Center to Case Western Reserve University
    • Collaborators revised (12)
    v23
  4. Notable Enrollment target: 1200 to 2000
    • Primary and study completion dates: Jul 31, 2023 to Jul 31, 2028
    v22
  5. Re-verified, no change to tracked fieldsv21
Show 19 earlier versionsHide 19 earlier versions
  1. Minor Primary and study completion dates: Apr 2023 to Jul 31, 2023
    • Site contacts updated at 2 of 10 sites
    v20
  2. Notable Primary and study completion dates: Apr 2022 to Apr 2023
    • Site contacts updated at 3 of 10 sites
    • Publications: 2 to 3
    v19
  3. Minor Enrollment target: 1000 to 1200v18 Show 5 more changesShow less
    • Study sites: 12 to 10
    • Start date: Oct 2005 to Oct 1, 2005
    • Study description expanded, about 279 words
    • Collaborators: 13 to 12
    • Study title expanded, about 5 words
  4. Notable Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) to University Hospitals Cleveland Medical Center
    • Primary and study completion dates: Sep 2017 to Apr 2022
    • Site contacts updated at 2 of 12 sites
    • Collaborators: 14 to 13
    v17
  5. Notable Primary and study completion dates: Sep 2012 to Sep 2017
    • Study sites: 10 to 12
    • Collaborators: 12 to 14
    v16
  6. Notable Primary completion date: Sep 2010 to Sep 2012v15
  7. Minor Study sites: 9 to 10
    • Primary completion date: Sep 2010
    • Study completion date: Sep 2010 to Sep 2012
    • Collaborators: 11 to 12
    v14
  8. Minor Site details revised at 1 of 9 sitesv13
  9. Minor Trial status: Completed to Recruiting
    • Study sites: 6 to 9
    • Study completion date: Sep 2007 to Sep 2010
    • Collaborators: 8 to 11
    v12
  10. Re-verified, no change to tracked fieldsv11
  11. Minor Trial status: Recruiting to Completed
    • Study completion date changed from estimate of Sep 2010 to Sep 2007
    • Site details revised at 6 of 6 sites
    v10
  12. 4 versions Re-verified since Jun 6, 2008, no change to tracked fieldsv6-v9
  13. Minor Study sites: 5 to 6
    • Collaborators: 7 to 8
    v5
  14. Re-verified, no change to tracked fieldsv4
  15. Minor Collaborators revised (7)v3
  16. Minor Eligibility criteria revisedv2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT00288119
Lead Sponsor Case Western Reserve University
Collaborators: University Hospitals Cleveland Medical Center, Washington University School of Medicine, Fred Hutchinson Cancer Center, University of Washington, Mercy Medical Center, Johns Hopkins University, Mayo Clinic, University of North Carolina, Chapel Hill, The Cleveland Clinic, University of Pennsylvania, Columbia University, VA Puget Sound Health Care System
Conditions
(from sponsor)
Barrett's Esophagus, Esophageal Neoplasm
Related terms Barrett Esophagus, Esophageal Neoplasms
Enrollment 2,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov