Condition: Hematologic Malignancy · Leukemia · Minimal Residual Disease · Sponsor: Munich Leukemia Laboratory
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.
This description comes directly from the study's public registry record.
Adam Wahida, MD · +49 (0)89 99017 338 · adam.wahida@mll.com
Torsten Haferlach, Prof. Dr.Dr. · +49 (0)89 99017 100 · torsten.haferlach@mll.com
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| MLL Munich Leukemia Laboratory | Munich, Bavaria, Germany | Recruiting |
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Source record: clinicaltrials.gov/study/NCT04466059