Colonoscopy or Fecal Occult Blood Test in Screening Healthy Participants for Colorectal Cancer

Study acronym: 00-046
StatusCompleted
PhasePhase 3
Started

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Record History

The 50 most recent of 56 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Trial status: Active, Not Recruiting to Completed
    • Primary and study completion dates changed from estimate of May 2026 to Mar 5, 2026
    • Start date: May 2000 to May 25, 2000
    v56
  2. Primary and study completion dates: May 2025 to May 2026v55
  3. Primary and study completion dates: May 2024 to May 2025v54
  4. Primary and study completion dates: May 2023 to May 2024v53
  5. Re-verified, no change to tracked fieldsv52
Show 45 earlier versionsHide 45 earlier versions
  1. Primary and study completion dates: May 2022 to May 2023v51
  2. Study sites revised (4)v50
  3. Primary and study completion dates: May 2021 to May 2022v49
  4. Primary and study completion dates: May 2020 to May 2021v48
  5. Primary and study completion dates: May 2019 to May 2020v47
  6. Primary and study completion dates: May 2018 to May 2019v46
  7. Re-verified, no change to tracked fieldsv45
  8. Primary and study completion dates: May 2017 to May 2018
    • Publications: 1 to 3
    v44
  9. Primary and study completion dates: May 2016 to May 2017v43
  10. Primary and study completion dates: May 2013 to May 2016v42
  11. Primary completion date: May 2010 to May 2013
    • Study completion date: May 2013
    v41
  12. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 4 of 4 sites
    v40
  13. Re-verified, no change to tracked fieldsv39
  14. Study sites: 3 to 4v38
  15. 5 versions Re-verified since Jun 21, 2008, no change to tracked fieldsv33-v37
  16. Interventions: annual screening (Procedure), comparison of screening methods (Procedure), fecal occult blood test (Procedure), screening colonoscopy… to annual screening (Procedure), fecal occult blood test (Procedure), screening colonoscopy (Procedure), standard follow-up care (Procedure)
    • Study arms: 0 to 4
    v32
  17. 2 versions Re-verified since May 13, 2008, no change to tracked fieldsv30-v31
  18. Study sites revised (3)v29
  19. Re-verified, no change to tracked fieldsv28
  20. Phase: Not specified to Phase 3v27
  21. Primary completion date: May 2010v26
  22. Start date: May 2000v25
  23. Study sites revised (3)v24
  24. Interventions: Intervention/procedure (Procedure), annual screening (Procedure), colonoscopy (Procedure), comparison of screening methods (Procedure)… to annual screening (Procedure), comparison of screening methods (Procedure), fecal occult blood test (Procedure), screening colonoscopy…v23
  25. Interventions: Intervention/procedure (Procedure), annual screening (Procedure), colonoscopy (Procedure), comparison of screening methods (Procedure)… to Intervention/procedure (Procedure), annual screening (Procedure), colonoscopy (Procedure), comparison of screening methods (Procedure)…v22
  26. Interventions: annual screening (Procedure), colonoscopic studies (Procedure), comparison of screening methods (Procedure), fecal occult blood test for… to Intervention/procedure (Procedure), annual screening (Procedure), colonoscopy (Procedure), comparison of screening methods (Procedure)…v21
  27. Study Status, Outcome Measuresv20
  28. Re-verified, no change to tracked fieldsv19
  29. Site contacts updated at 1 of 3 sitesv18
  30. Study sites revised (3)v17
  31. Re-verified, no change to tracked fieldsv16
  32. Study Status, Study Descriptionv15
  33. 4 versions Re-verified since Dec 4, 2006, no change to tracked fieldsv11-v14
  34. Enrollment target: 4952
    • Study description expanded, about 15 words
    v10
  35. 3 versions Re-verified since Jun 7, 2006, no change to tracked fieldsv7-v9
  • 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.
RATIONALE: Screening tests, such as colonoscopy and fecal occult blood test, may help doctors find tumor cells early and plan better treatment for colorectal cancer. PURPOSE: This randomized phase III trial is studying colonoscopy to see how well it works compared to fecal occult blood test in screening healthy participants for colorectal cancer.
Trial Details
NCT Number NCT00102011
Lead Sponsor Memorial Sloan Kettering Cancer Center
Collaborators: National Cancer Institute (NCI)
Conditions
(from sponsor)		 Colorectal Cancer
Related terms Colonic Neoplasms, Colorectal Neoplasms, Rectal Neoplasms
Enrollment 4,952 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov