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Digital Tomosynthesis Mammography and Digital Mammography in Screening Patients for Breast Cancer

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Minor Primary completion moved earlier from Dec 31, 2028 to Mar 31, 2028
    • Study completion moved earlier from Dec 31, 2030 to Dec 31, 2029
    v42
  2. Minor 11 versions Re-verified since Aug 15, 2025, no change to tracked fieldsv31-v41
  3. Notable Primary completion date: Dec 31, 2030 to Dec 31, 2028
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: 128905 to 108508
    • Site details revised at 149 of 149 sites
    v30
  4. Minor Study sites: 132 to 149v29
  5. Minor Re-verified, no change to tracked fieldsv28
Show 26 earlier versionsHide 26 earlier versions
  1. Notable Start date: Jul 6, 2017 to Sep 28, 2017v27
  2. Minor 2 versions Re-verified since Jun 8, 2022, no change to tracked fieldsv25-v26
  3. Minor Enrollment target: 164946 to 128905
    • Eligibility criteria shortened, about 13 words
    • Study description expanded, about 1 word
    v24
  4. Minor Study sites: 130 to 132v23
  5. Minor Study sites: 114 to 130v22
  6. Notable Primary completion date: Aug 1, 2025 to Dec 31, 2030
    • Study completion date: Aug 1, 2030 to Dec 31, 2030
    v21
  7. Minor Study sites: 113 to 114v20
  8. Minor Study sites: 105 to 113v19
  9. Minor Study sites: 83 to 105v18
  10. Minor Study sites: 65 to 83v17
  11. Minor Study sites: 45 to 65v16
  12. Minor Collaborators: 1 to 2v15
  13. Minor Study sites: 39 to 45v14
  14. Minor Study sites: 36 to 39v13
  15. Minor Study sites: 32 to 36v12
  16. Minor Study sites: 29 to 32v11
  17. Minor Study sites: 21 to 29v10
  18. Minor Study sites: 14 to 21v9
  19. Minor Study sites: 9 to 14v8
  20. Minor Study sites: 6 to 9v7
  21. Notable Primary completion date: Aug 1, 2030 to Aug 1, 2025v6
  22. Minor Re-verified, no change to tracked fieldsv5
  23. Minor Study sites: 1 to 6v4
  24. Minor Site contact updatedv3
  25. Minor Re-verified, no change to tracked fieldsv2
  1. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 randomized phase III trial studies digital tomosynthesis mammography and digital mammography in screening patients for breast cancer. Screening for breast cancer with tomosynthesis mammography may be superior to digital mammography for breast cancer screening and may help reduce the need for additional imaging or treatment.
Trial Details
NCT Number NCT03233191
Lead Sponsor ECOG-ACRIN Cancer Research Group
Collaborators: National Cancer Institute (NCI), Canadian Cancer Trials Group (CCTG)
Conditions
(from sponsor)
Breast Screening
Enrollment 108,508 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov