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Better Leukemia Diagnostics Through AI (BELUGA)

Study acronym: BELUGA
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 years later Jul 31, 2025 → Jul 31, 2027
See other at-risk trials from Munich Leukemia Laboratory

Record History

  1. Primary and study completion pushed from Jul 31, 2025 to Jul 31, 2027 Eligibility criteria expanded, about 7 words · Secondary endpoints: details revised at 1 of 4 entries · Publications: details revised at 1 of 1 entry Show 3 more changesShow less
    • Eligibility criteria expanded, about 7 words
    • Secondary endpoints: details revised at 1 of 4 entries
    • Publications: details revised at 1 of 1 entry
  2. Primary completion date: Jul 31, 2024 to Jul 31, 2025v8
  3. Primary completion date: Jul 31, 2023 to Jul 31, 2024 Completion date: Jul 31, 2023 to Jul 31, 2025v7 Show 1 more changeShow less
    • Completion date: Jul 31, 2023 to Jul 31, 2025
  4. Primary and study completion dates: Jul 31, 2022 to Jul 31, 2023v6
  5. Primary and study completion dates: Jul 31, 2021 to Jul 31, 2022v5
Show 3 earlier versionsHide 3 earlier versions
  1. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Aug 1, 2020 to Jan 5, 2020 · Site details revisedv4 Show 2 more changesShow less
    • Start date changed from estimate of Aug 1, 2020 to Jan 5, 2020
    • Site details revised
  2. 2 versions Re-verified, no change to tracked fieldsv2-v3
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
To the best of our knowledge, BELUGA will be the first prospective trial investigating the usefulness of deep learning-based hematologic diagnostic algorithms. Taking advantage of an unprecedented collection of diagnostic samples consisting of flow cytometry datapoints and digitalized blood-smears, categorization of yet undiagnosed patient samples will prospectively be compared to current state-of-the-art diagnosis at the Munich Leukemia Laboratory (hereafter MLL). In total, a collection of 25,000 digitalized blood smears and 25,000 flow cytometry datapoints will be prospectively used to train an AI-based deep neuronal network for correct categorization. Subsequently, the superiority will be challenged for the primary endpoints: sensitivity and specificity of diagnosis, most probable diagnosis, and time to diagnose. The secondary endpoints will compare the consequences regarding further diagnostic work-up and, thus, clinical decision making between routine diagnosis and AI guided diagnostics. BELUGA will set the stage for the introduction of AI-based hematologic diagnostics in a real-world setting.
Trial Details
NCT Number NCT04466059
Lead Sponsor Munich Leukemia Laboratory
Conditions Hematologic Malignancy, Leukemia, Minimal Residual Disease, Lymphoma, Blood Cancer
Enrollment 25,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov