Minimally Invasive Molecular Approaches for the Diagnosis of Barrett's Esophagus and Esophageal Adenocarcinoma

StatusCompleted
PhaseNot applicable
Started

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Record History

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  1. Primary endpoints: details revised at 1 of 3 entries Show 6 more changesShow less
    • Trial completed
    • Primary completion date changed from estimate of Jul 30, 2030 to Nov 25, 2025
    • Enrollment target: estimated 1550 to confirmed 1526
    • Study sites: 9 to 8
    • Eligibility criteria expanded, about 41 words
    • Secondary endpoints: details revised at 3 of 4 entries
  2. Primary completion date: Jan 2, 2026 to Jul 30, 2030
    • Study completion date: Jan 2, 2027 to Jul 30, 2030
    v18
  3. Eligibility criteria shortened, about 102 words
    • Study description revised
    v17
  4. Enrollment target: 1500 to 1550v16
  5. Enrollment target: 1350 to 1500
    • Site details revised at 4 of 9 sites
    v15
Show 13 earlier versionsHide 13 earlier versions
  1. Collaborators expanded, about 4 wordsv14
  2. Re-verified, no change to tracked fieldsv13
  3. Site details revised at 2 of 9 sitesv12
  4. Site details revised at 6 of 9 sitesv11
  5. Study sites: 7 to 9v10
  6. Re-verified, no change to tracked fieldsv9
  7. Study sites: 6 to 7
    • Eligibility criteria expanded, about 10 words
    v8
  8. Study sites: 5 to 6
    • Eligibility criteria expanded, about 32 words
    v7
  9. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 5
    • Start date changed from estimate of Aug 1, 2021 to Jul 1, 2021
    v6
  10. Start date: Jan 1, 2022 to Aug 1, 2021
    • Eligibility criteria expanded, about 39 words
    • Secondary endpoints: details revised at 1 of 4 entries
    v5
  11. Primary completion date: Jan 2, 2025 to Jan 2, 2026
    • Start date: Jan 1, 2021 to Jan 1, 2022
    • Study completion date: Jan 2, 2026 to Jan 2, 2027
    v4
  12. Start date: Jun 1, 2020 to Jan 1, 2021v3
  13. Start date: Nov 4, 2019 to Jun 1, 2020
    • Enrollment target: 1200 to 1350
    v2
  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.
Mayo Clinic
1,024 trials monitored
See 128 trials at risk
Esophageal Cancer
1,051 trials monitored
See 53 trials at risk
This study will evaluate if the sponge capsule device can accurately detect the presence of Barrett's Esophagus and prevalent dysplasia/adenocarcinoma detection, in a screening population, with and without chronic gastroesophageal reflux disease.
Trial Details
NCT Number NCT03961945
Lead Sponsor Mayo Clinic
Collaborators: National Cancer Institute (NCI)
Conditions
(from sponsor)		 Barrett Esophagus, Esophageal Adenocarcinoma
Related terms Adenocarcinoma Of Esophagus, Barrett Esophagus, Esophageal Neoplasms, Gastroesophageal Reflux
Enrollment 1,526 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov