AI-Assisted Acute Myeloid Leukemia Evaluation With the Leukemia End-to-End Analysis Platform (LEA… (NCT07203885) | Clinical Trial Compass
CompletedNot Applicable
AI-Assisted Acute Myeloid Leukemia Evaluation With the Leukemia End-to-End Analysis Platform (LEAP) Versus Clinician-Only Assessment
United States10 participantsStarted 2025-09-09
Plain-language 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 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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Diagnostic performance of APL detection
Timeframe: Periprocedural (at the time of slide review)