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Intensive Cancer Screening After Cryptogenic Stroke

Study acronym: INCOGNITO
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 11 months later Jan 2027 → Jan 2028
See other at-risk trials from Ottawa Hospital Research Institute

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Jan 2027 to Jan 2028
    • Study sites: 1 to 3
    • Interventions: FDG PET/CT (Diagnostic Test), Usual Care (Diagnostic Test) to FDG PET/CT (Diagnostic Test), Usual Care (Diagnostic Test)
    • Eligibility criteria expanded, about 5 words
  2. Primary completion date: Jan 2025 to Jan 2027
    • Study completion date: Jan 2026 to Jan 2027
    • Secondary endpoints: details revised at 4 of 5 entries
    • Site contact updated
    v5
  3. Trial status: Not Yet Recruiting to Recruiting
    • Primary completion date: Jan 2024 to Jan 2025
    • Study completion date: Jan 2025 to Jan 2026
    • Start date changed from estimate of Jun 2023 to Sep 1, 2023
    v4
  4. Start date: Feb 2023 to Jun 2023v3
  5. Eligibility criteria shortened, about 6 wordsv2
  6. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The INCOGNITO Pilot Trial is a single centre pilot prospective randomized open-label blinded endpoint (PROBE) trial to assess the feasibility of a full-scale randomized trial to determine whether an occult cancer screening strategy of FDG PET/CT (F-fluorodeoxyglucose positron emission/computed tomography) in addition to usual care increases the number of occult cancers diagnosed after screening compared to usual care cancer screening alone in patients with cryptogenic stroke.
Trial Details
NCT Number NCT05733416
Lead Sponsor Ottawa Hospital Research Institute
Collaborators: Brain Canada, Heart and Stroke Foundation of Canada, Canadian Stroke Consortium (CSC)
Conditions
(from sponsor)		 Occult Cancer
Related terms Ischemic Stroke
Enrollment 45 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov