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Better Leukemia Diagnostics Through AI (BELUGA)

Recruitingn/aAges 18 Years - anyAllMunich Leukemia Laboratory
NCT04466059 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: * Patients having been diagnosed with a suspected hematological disorder * The suspected diagnoses constitute a primary diagnosis * Only samples of patients min.18 years of age will be used * Samples must suffice quality attributes which are denoted in "Exclusion Criteria" Exclusion Criteria: * The sample is not fit for state-of-the-art diagnosis or fails initial quality control. For quality insurance, we will exclude samples in heparin- instead of EDTA. Samples with damage due to atmospheric reasons (freeze-thaw damage or elevated temperature) will be excluded. * Samples with too scarce material jeopardizing routine gold-standard diagnosis will be excluded. * Bone marrow aspirates without sufficient material to assess malignant or healthy hematopoiesis.
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What it tests

  • Automated AI-Guided Diagnosis of Hematological Malignancies
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Where

1 site
MLL Munich Leukemia Laboratory
Munich, Germany
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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