Improving leukemia diagnosis using artificial intelligence
A Case-Control Study To Determine The Suitability Of Artificial Intelligence For Leukemia Diagnostics
This study is testing whether an artificial intelligence system can improve the diagnosis of leukemia by comparing its accuracy and speed to traditional methods using a large set of blood samples.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 25000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Munich Leukemia Laboratory Industry-sponsored |
| Locations | 1 site (Munich, Bavaria) |
| Trial ID | NCT04466059 on ClinicalTrials.gov |
What this trial studies
The BELUGA project aims to evaluate the effectiveness of deep learning algorithms in diagnosing hematologic malignancies by comparing AI-based diagnostics to current standard methods. It will utilize a large collection of 25,000 digitalized blood smears and flow cytometry data to train an AI model for accurate categorization of undiagnosed patient samples. The study will assess the sensitivity, specificity, and time to diagnosis of the AI system compared to traditional diagnostic approaches. This prospective trial is designed to provide real-world evidence of the AI's diagnostic capabilities.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who have been diagnosed with a suspected hematological disorder.
Not a fit: Patients whose samples do not meet quality standards for diagnosis or who have insufficient material for analysis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to faster and more accurate diagnoses for patients with blood cancers.
How similar studies have performed: While there have been studies using AI for diagnostics, this is one of the first prospective trials specifically focused on hematologic malignancies, making it a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Munich, Bavaria
- MLL Munich Leukemia Laboratory — Munich, Bavaria, Germany (Recruiting)
Study contacts
- Principal investigator: Wolfgang Kern, Prof. Dr. — MLL Munich Leukemia Laboratory
- Study coordinator: Adam Wahida, MD
- Email: adam.wahida@mll.com
- Phone: +49 (0)89 99017 338
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.