Actively Recruiting
Better Leukemia Diagnostics Through AI (BELUGA)
Led by Munich Leukemia Laboratory · Updated on 2024-12-17
25000
Participants Needed
1
Research Sites
290 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Better Leukemia Diagnostics Through AI (BELUGA)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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"
You will not qualify if you...
- The sample is not fit for state-of-the-art diagnosis or fails initial quality control
- Samples in heparin tubes instead of EDTA will be excluded
- Samples damaged by atmospheric reasons such as 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 will be excluded
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
MLL Munich Leukemia Laboratory
Munich, Bavaria, Germany, 81377
Actively Recruiting
Research Team
A
Adam Wahida, MD
CONTACT
T
Torsten Haferlach, Prof. Dr.Dr.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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