Prospective Evaluation of Breast-Conserving Surgery Alone in Low-Risk Ductal Carcinoma in Situ (DCIS)

Study acronym: ELISA
StatusActive, Not Recruiting
PhaseNot specified
Started

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Record History

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  1. Enrollment closed, study ongoing
    • Study sites: 25 to 24
    • Eligibility criteria expanded, about 11 words
  2. Site contacts updated at 1 of 25 sitesv36
  3. Study sites: 24 to 25v35
  4. Collaborators expanded, about 10 wordsv34
  5. Site contacts updated at 11 of 24 sitesv33
Show 31 earlier versionsHide 31 earlier versions
  1. Study sites: 23 to 24v32
  2. Primary completion date: Mar 31, 2035 to Nov 30, 2030
    • Study sites: 22 to 23
    • Study completion date: May 31, 2035 to Nov 30, 2035
    v31
  3. Study sites: 21 to 22v30
  4. Study sites: 20 to 21v29
  5. Study sites revised (20)v28
  6. Study sites: 18 to 20v27
  7. Study sites: 17 to 18v26
  8. Study sites: 16 to 17v25
  9. Study sites: 15 to 16v24
  10. Site contacts updated at 1 of 15 sitesv23
  11. Study sites: 14 to 15v22
  12. Site details revised at 1 of 14 sitesv21
  13. Study sites: 13 to 14v20
  14. Study sites: 12 to 13v19
  15. Study sites: 11 to 12v18
  16. Study sites: 10 to 11v17
  17. Eligibility criteria expanded, about 33 words
    • Study description shortened, about 14 words
    v16
  18. Start date: Oct 20, 2022 to Nov 23, 2022
    • Study completion date: Jul 31, 2035 to May 31, 2035
    • Eligibility criteria shortened, about 5 words
    v15
  19. Site details revised at 1 of 10 sitesv14
  20. Study sites: 9 to 10v13
  21. Site details revised at 1 of 9 sitesv12
  22. Study sites: 8 to 9v11
  23. Study sites: 6 to 8v10
  24. Study sites: 5 to 6v9
  25. Site details revised at 1 of 5 sitesv8
  26. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 7 to 5
    • Start date changed from estimate of Oct 1, 2022 to Oct 20, 2022
    v7
  27. Start date: May 1, 2022 to Oct 1, 2022v6
  28. Start date: Mar 1, 2022 to May 1, 2022v5
  29. Re-verified, no change to tracked fieldsv4
  30. Primary completion date: May 31, 2034 to Mar 31, 2035
    • Start date: Nov 1, 2021 to Mar 1, 2022
    • Study completion date: Sep 30, 2034 to Jul 31, 2035
    • Eligibility criteria expanded, about 10 words
    v3
  31. Start date: May 1, 2021 to Nov 1, 2021v2
  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.
To evaluate whether the combination of clinicopathological factors and the use of the Oncotype DX DCIS score can avoid radiation in women with low risk DCIS who have had breast conserving surgery (BCS)
Trial Details
NCT Number NCT04797299
Lead Sponsor Ontario Clinical Oncology Group (OCOG)
Collaborators: Canadian Institutes of Health Research (CIHR), Hamilton Health Sciences Corporation
Conditions
(from sponsor)		 DCIS
Related terms Carcinoma, Intraductal, Noninfiltrating
Enrollment 526 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov