AI-Assisted Acute Myeloid Leukemia Evaluation With the Leukemia End-to-End Analysis Platform (LEAP) Versus Clinician-Only Assessment

NAEnrolling by invitationINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

September 11, 2025

Primary Completion Date

November 1, 2025

Study Completion Date

November 1, 2025

Conditions
Acute Promyelocytic Leukemia (APL)Acute Myeloid Leukaemia (AML)
Interventions
BEHAVIORAL

Unaided Review First, Then AI-Assisted Review

Readers first complete Block X (Unaided) on their assigned subset SX (up to 40 slides). They then complete Block Y (AI-Assisted) on two separate subsets: SY1 (up to 40 slides; AI as Double-Check) and SY2 (up to 40 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.

BEHAVIORAL

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.

Trial Locations (1)

02115

Harvard Medical School, Boston

All Listed Sponsors
collaborator

National Taiwan University Hospital

OTHER

collaborator

Far Eastern Memorial Hospital

OTHER

collaborator

Taipei Veterans General Hospital, Taiwan

OTHER_GOV

collaborator

Brigham and Women's Hospital

OTHER

collaborator

Massachusetts General Hospital

OTHER

lead

Harvard Medical School (HMS and HSDM)

OTHER

NCT07203885 - AI-Assisted Acute Myeloid Leukemia Evaluation With the Leukemia End-to-End Analysis Platform (LEAP) Versus Clinician-Only Assessment | Biotech Hunter | Biotech Hunter