NCT07203885Completed
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 · Last updated 31 Oct 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 10 (actual)
- First submitted
- 8 Sept 2025
- Start date
- 9 Sept 2025
- Primary completion date
- 10 Oct 2025
- Lead sponsor
- Harvard Medical School (HMS and HSDM)
- Diseases
- Acute myeloid leukemia, Childhood cancers
- NCT number
- NCT07203885
What you commit to
- Study type: Interventional
- Participants enrolled: 10
- From 9 Sept 2025 to the primary completion date, 10 Oct 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Poor-quality or unreadable slides
- Cases used in AI training
Who the study is looking for
- Wright-Giemsa-stained bone marrow aspirate smears
- 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
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Harvard Medical School Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.