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Better Leukemia Diagnostics Through AI (BELUGA)
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.
Details
| Lead sponsor | Munich Leukemia Laboratory |
|---|---|
| Status | RECRUITING |
| Enrolment | 25000 |
| Start date | Sun Jan 05 2020 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Thu Jul 31 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Hematologic Malignancy
- Leukemia
- Minimal Residual Disease
- Lymphoma
- Blood Cancer
Interventions
- Automated AI-Guided Diagnosis of Hematological Malignancies
Countries
Germany