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Genetic Determinants of Barrett's Esophagus and Esophageal Adenocarcinoma

Study acronym: FBE
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Site contacts updated at 2 of 10 sitesv26
  2. 2 versions Re-verified since May 20, 2025, no change to tracked fieldsv24-v25
  3. Lead sponsor: University Hospitals Cleveland Medical Center to Case Western Reserve University Collaborators revised (12)v23 Show all 2 changesShow less
    • Collaborators revised (12)

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  4. Enrollment target: 1200 to 2000 Primary and study completion dates: Jul 31, 2023 to Jul 31, 2028v22 Show all 2 changesShow less
    • Primary and study completion dates: Jul 31, 2023 to Jul 31, 2028
  5. Re-verified, no change to tracked fieldsv21
Show 19 earlier versionsHide 19 earlier versions
  1. Primary and study completion dates: Apr 2023 to Jul 31, 2023 Site contacts updated at 2 of 10 sitesv20 Show all 2 changesShow less
    • Site contacts updated at 2 of 10 sites
  2. Primary and study completion dates: Apr 2022 to Apr 2023 Site contacts updated at 3 of 10 sites · Publications: 2 to 3v19 Show all 3 changesShow less
    • Site contacts updated at 3 of 10 sites
    • Publications: 2 to 3

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  3. Enrollment target: 1000 to 1200 Study sites: 12 to 10 · Start date: Oct 2005 to Oct 1, 2005 · Study description expanded, about 279 words · 2 morev18 Show all 6 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

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  4. 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 13v17 Show all 4 changesShow less
    • Primary and study completion dates: Sep 2017 to Apr 2022
    • Site contacts updated at 2 of 12 sites
    • Collaborators: 14 to 13

    See this version in full on ClinicalTrials.gov ↗

  5. Primary and study completion dates: Sep 2012 to Sep 2017 Study sites: 10 to 12 · Collaborators: 12 to 14v16 Show all 3 changesShow less
    • Study sites: 10 to 12
    • Collaborators: 12 to 14

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  6. Primary completion date: Sep 2010 to Sep 2012v15
  7. Study sites: 9 to 10 Primary completion date: Sep 2010 · Completion date: Sep 2010 to Sep 2012 · Collaborators: 11 to 12v14 Show all 4 changesShow less
    • Primary completion date: Sep 2010
    • Completion date: Sep 2010 to Sep 2012
    • Collaborators: 11 to 12

    See this version in full on ClinicalTrials.gov ↗

  8. Site details revised at 1 of 9 sitesv13
  9. Trial status: Completed to Recruiting Study sites: 6 to 9 · Completion date: Sep 2007 to Sep 2010 · Collaborators: 8 to 11v12 Show all 4 changesShow less
    • Study sites: 6 to 9
    • Completion date: Sep 2007 to Sep 2010
    • Collaborators: 8 to 11

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  10. Re-verified, no change to tracked fieldsv11
  11. Trial status: Recruiting to Completed Study completion date changed from estimate of Sep 2010 to Sep 2007 · Site details revised at 6 of 6 sitesv10 Show all 3 changesShow less
    • Study completion date changed from estimate of Sep 2010 to Sep 2007
    • Site details revised at 6 of 6 sites
  12. 4 versions Re-verified since Jun 6, 2008, no change to tracked fieldsv6-v9
  13. Study sites: 5 to 6 Collaborators: 7 to 8v5 Show all 2 changesShow less
    • Collaborators: 7 to 8

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  14. Re-verified, no change to tracked fieldsv4
  15. Collaborators revised (7)v3 Show moreShow less

    See this version in full on ClinicalTrials.gov ↗

  16. Eligibility criteria revisedv2 Show moreShow less

    See this version in full on ClinicalTrials.gov ↗

  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • 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 Barrett's Esophagus, Esophageal Neoplasm
Enrollment 2,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov