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Colonoscopy vs Stool Testing for Older Adults With Colon Polyps

Study acronym: COOP
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Enrollment reduced 28% 8946 → 6434 participants
See other at-risk trials from Dartmouth-Hitchcock Medical Center

Record History

See every version on ClinicalTrials.gov ↗

  1. Enrollment reduced: 8946 → 6434 participants Show 4 more changesShow less
    • Eligibility criteria expanded, about 11 words
    • Secondary endpoints: details revised at 4 of 6 entries
    • Site details revised at 2 of 24 sites
    • Publications: 5 to 7
  2. Study sites: 22 to 24v17
  3. Re-verified, no change to tracked fieldsv16
  4. Study sites: 19 to 22v15
  5. Study sites: 16 to 19v14
Show 12 earlier versionsHide 12 earlier versions
  1. Site details revised at 1 of 16 sitesv13
  2. Study sites: 13 to 16v12
  3. Study sites: 10 to 13v11
  4. Study sites: 5 to 10v10
  5. Primary completion date: Dec 31, 2028 to May 31, 2030
    • Study completion date: Dec 31, 2033 to Dec 31, 2035
    v9
  6. Site contacts updated at 1 of 5 sitesv8
  7. Eligibility criteria shortened, about 16 words
    • Study description revised
    • Site details revised at 1 of 5 sites
    v7
  8. Re-verified, no change to tracked fieldsv6
  9. Site details revised at 1 of 5 sitesv5
  10. Site details revised at 3 of 5 sitesv4
  11. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of May 15, 2023 to Jun 14, 2023
    • Site details revised at 5 of 5 sites
    • Study title expanded, about 1 word
    v3
  12. Start date: Feb 1, 2023 to May 15, 2023
    • Eligibility criteria expanded, about 9 words
    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 is a multi-site comparative effectiveness randomized controlled trial (RCT) comparing annual fecal immunochemical testing (FIT) and colonoscopy for post-polypectomy surveillance among adults aged 65-82 with a history of colorectal polyps who are due for surveillance colonoscopy.
Trial Details
NCT Number NCT05612347
Lead Sponsor Dartmouth-Hitchcock Medical Center
Collaborators: Patient-Centered Outcomes Research Institute
Conditions
(from sponsor)		 Colorectal Polyp, Colorectal Neoplasms, Colorectal Adenoma, Colorectal Cancer, Digestive System Disease
Related terms Colorectal Neoplasms, Digestive System Diseases
Enrollment 6,434 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov