AI-Assisted Acute Myeloid Leukemia Evaluation With the Leukemia End-to-End Analysis Platform (LEAP) Versus Clinician-Only Assessment
NCT ID: NCT07203885
Last Updated: 2025-10-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
10 participants
INTERVENTIONAL
2025-09-09
2025-10-10
Brief Summary
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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.
Detailed Description
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This is a single-session, within-reader study. Participants will be randomly assigned to one of two study arms, which differ in the order of diagnostic blocks:
\* Arm 1 (X -\> Y): Block X (Unaided Review): Clinicians review WSIs without AI support. Diagnostic accuracy, time to decision, and confidence will be recorded.
Block Y (AI-Assisted Review): Comprising two sub-blocks presented in randomized order:
Y1 (AI as Double-Check): Clinicians provide an initial diagnosis and confidence score without the aid of AI. AI predictions are then revealed, and clinicians may revise their diagnosis. Both pre-AI and post-AI decisions will be recorded.
Y2 (AI as First Look): Clinicians review WSIs with AI-predicted diagnoses visible from the beginning.
\* Arm 2 (Y -\> X): Block Y (AI-Assisted Review): Sub-blocks Y1 and Y2 presented in randomized order.
Block X (Unaided Review): As described above.
Each clinician will review 102 de-identified WSIs. For each reader, slides will be randomly divided into three disjoint subsets (e.g. 34/34/34), stratified by APL status, and assigned to Block X (Unaided), Block Y1 (AI as Double-Check), or Block Y2 (AI as First Look). No slide will be shown to the same reader in more than one block.
In addition, the AI system will independently generate diagnostic predictions for all WSIs to enable benchmarking; however, this does not constitute a participant arm.
Ground-truth diagnoses will be determined by molecular confirmation and expert consensus.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
DIAGNOSTIC
TRIPLE
Study Groups
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Unaided Review First, Then AI-Assisted Review
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.
Unaided Review First, Then AI-Assisted Review
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.
AI-Assisted Review First, Then Unaided Review
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.
AI-Assisted Review First, Then Unaided Review
Readers first complete Block Y (AI-Assisted) on two assigned subsets: SY1 (up to 40 slides; AI as Double-Check) and SY2 (up to 40 slides; AI as First Look), with the order of Y1 and Y2 randomized. They then complete Block X (Unaided) on subset SX (up to 40 slides). For each reader, SX, SY1, and SY2 are disjoint and stratified by APL status.
Interventions
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Unaided Review First, Then AI-Assisted Review
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.
AI-Assisted Review First, Then Unaided Review
Readers first complete Block Y (AI-Assisted) on two assigned subsets: SY1 (up to 40 slides; AI as Double-Check) and SY2 (up to 40 slides; AI as First Look), with the order of Y1 and Y2 randomized. They then complete Block X (Unaided) on subset SX (up to 40 slides). For each reader, SX, SY1, and SY2 are disjoint and stratified by APL status.
Eligibility Criteria
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Inclusion Criteria
* Final diagnosis confirmed through molecular testing in conjunction with expert pathology evaluation
* 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 Criteria
* Cases used in AI training
ALL
No
Sponsors
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National Taiwan University Hospital
OTHER
Far Eastern Memorial Hospital
OTHER
Taipei Veterans General Hospital, Taiwan
OTHER_GOV
Brigham and Women's Hospital
OTHER
Massachusetts General Hospital
OTHER
Harvard Medical School (HMS and HSDM)
OTHER
Responsible Party
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Kun-Hsing Yu
Associate Professor of Biomedical Informatics
Locations
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Harvard Medical School
Boston, Massachusetts, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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IRB23-0403
Identifier Type: -
Identifier Source: org_study_id