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Breast Cancer Screening: Digital Breast Tomosynthesis Versus Digital 2D Mammography

Study acronym: TOSYMA
StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Primary and study completion dates: Mar 31, 2026 to Mar 31, 2027v17
  2. Primary and study completion dates: Mar 31, 2025 to Mar 31, 2026v16
  3. 2 versions Re-verified since Mar 16, 2022, no change to tracked fieldsv14-v15
  4. Primary completion date: Dec 31, 2020 to Mar 31, 2025
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 120000 to confirmed 99689
    • Site details revised at 21 of 21 sites
    v13
  5. Enrollment target: 80000 to 120000v12 Show 5 more changesShow less
    • Primary completion date: Jul 2023 to Dec 31, 2020
    • Study completion date: Jul 2023 to Mar 31, 2025
    • Eligibility criteria expanded, about 7 words
    • Study description expanded, about 120 words
    • Site details revised at 1 of 21 sites
Show 10 earlier versionsHide 10 earlier versions
  1. Re-verified, no change to tracked fieldsv11
  2. Site details revised at 2 of 21 sitesv10
  3. Site details revised at 4 of 21 sitesv9
  4. Site details revised at 8 of 21 sitesv8
  5. Site details revised at 1 of 21 sitesv7
  6. Site details revised at 5 of 21 sitesv6
  7. Trial status: Not Yet Recruiting to Recruiting
    • Primary and study completion dates: Jun 2023 to Jul 2023
    • Start date changed from estimate of Jun 2018 to Jul 5, 2018
    • Site details revised at 21 of 21 sites
    v5
  8. Publications: details revised at 1 of 4 entriesv4
  9. Primary and study completion dates: May 2023 to Jun 2023
    • Start date: May 2018 to Jun 2018
    v3
  10. Start date: Mar 2018 to May 2018
    • Study sites: 1 to 21
    • Primary and study completion dates: Mar 2023 to May 2023
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This study is a randomized, multicenter, multivendor, controlled, diagnostic superiority trial to compare digital breast tomosynthesis plus synthesized 2D mammograms (DBT+s2D) versus standard 2D full-field digital mammography (2D-FFDM) regarding the effectiveness as screening modality.
Trial Details
NCT Number NCT03377036
Lead Sponsor University Hospital Muenster
Collaborators: German Research Foundation
Conditions
(from sponsor)		 Breast Cancer Screening
Related terms Breast Neoplasms
Enrollment 99,689 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov