Clinical trial · Interventional
AI-Assisted Acute Myeloid Leukemia Evaluation With the Leukemia End-to-End Analysis Platform (LEAP) Versus Clinician-Only Assessment
Prospective Studies on Artificial Intelligence for Cancer Pathology Evaluation
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 bone marrow samples under a microscope to make this diagnosis, but it can be challenging and time-consuming. In this study, doctors will review bone marrow samples under three different conditions: * Unaided Review: Without AI assistance. * AI as Double-Check: AI-generated evaluation shown after the doctor makes an initial decision. * AI as First Look: AI-generated evaluation shown at the start of the review. Doctors will be randomly assigned to different orders of these three conditions. This design will allow us to compare how AI support affects diagnostic accuracy, speed, and confidence.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukaemia (AML) | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Acute Promyelocytic Leukemia (APL) | Acute Promyelocytic Leukemia | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AI-Assisted Review First, Then Unaided Review | Behavioral | — | UNRESOLVED |
| Unaided Review First, Then AI-Assisted Review | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Unaided Review First, Then AI-Assisted Review
- description
- Readers first complete Block X (Unaided) on their assigned subset SX (34 slides). They then complete Block Y (AI-Assisted) on two separate subsets: SY1 (34 slides; AI as Double-Check) and SY2 (34 slides; AI as First Look). Within Block Y, the order of Y1 and Y2 is randomized. For each reader, SX, SY1, and SY2 are disjoint and stratified by APL status.
- interventionNames
- Behavioral: Unaided Review First, Then AI-Assisted Review
- type
- ACTIVE_COMPARATOR
- label
- AI-Assisted Review First, Then Unaided Review
- description
- Readers first complete Block Y (AI-Assisted) on two assigned subsets: SY1 (34 slides; AI as Double-Check) and SY2 (34 slides; AI as First Look), with the order of Y1 and Y2 randomized. They then complete Block X (Unaided) on subset SX (34 slides). For each reader, SX, SY1, and SY2 are disjoint and stratified by APL status.
- interventionNames
- Behavioral: AI-Assisted Review First, Then Unaided Review
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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
References
Publications (0)
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