Status:
COMPLETED
AI-Assisted Acute Myeloid Leukemia Evaluation With the Leukemia End-to-End Analysis Platform (LEAP) Versus Clinician-Only Assessment
Lead Sponsor:
Harvard Medical School (HMS and HSDM)
Collaborating Sponsors:
National Taiwan University Hospital
Far Eastern Memorial Hospital
Conditions:
Acute Promyelocytic Leukemia (APL)
Acute Myeloid Leukaemia (AML)
Eligibility:
All Genders
Phase:
NA
Brief Summary
This study will test whether artificial intelligence (AI) can help doctors diagnose a rare blood cancer called acute promyelocytic leukemia (APL) more quickly and accurately. Doctors usually examine b...
Detailed Description
This study aims to evaluate the effect of artificial intelligence (AI) assistance on clinicians' diagnostic performance in detecting acute promyelocytic leukemia (APL) using Wright-Giemsa-stained bone...
Eligibility Criteria
Inclusion
- Inclusion Criteria for Pathology Slides (i.e., Cases):
- Wright-Giemsa-stained bone marrow aspirate smears
- Final diagnosis confirmed through molecular testing in conjunction with expert pathology evaluation
- Exclusion Criteria for Pathology Slides (i.e., Cases):
- Poor-quality or unreadable slides
- Cases used in AI training
- Inclusion Criteria for Readers (i.e., Participants):
- Board-certified or board-eligible pathologists, or board-certified/board-eligible hematologists who routinely make hematopathology diagnoses in their clinical practice
- Willingness to complete both unaided and AI-assisted review sessions
Exclusion
Key Trial Info
Start Date :
September 9 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 10 2025
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT07203885
Start Date
September 9 2025
End Date
October 10 2025
Last Update
October 31 2025
Active Locations (1)
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1
Harvard Medical School
Boston, Massachusetts, United States, 02115