Multi-center Validation Study of a Large Language Model-based Intelligent Agent for Blood Cell Analysis

I. Study Background: Currently, in most medical institutions, the review of blood cell analysis still heavily relies on manual verification by laboratory staff. This process requires a comprehensive analysis of instrument parameters, alarm flags, historical comparison results, and, when necessary, microscopic examination. However, with the increasing volume of test samples and the high concentration of review tasks during peak hours, the traditional manual review model increasingly shows problems such as prolonged turnaround time (TAT), uneven workload distribution, and decreased consistency in reviews. In recent years, intelligent review systems based on Large Language Models (LLM) have shown potential in analyzing abnormal results and stratifying sample risks by integrating preset rules, clinical diagnostic information, and multi-dimensional laboratory data, which is expected to optimize the review workflow. II. Study Objective: To evaluate the difference in overall sample review turnaround time between the experimental process and the control process during the formal study phase, and to test its superiority. III. Subjects: The investigators need to recruit approximately 20,000 subjects, regardless of age or gender. IV. Study Procedures: If participants agree to participate in the study, participants only need to allow us to use participants test results after participants have completed your routine blood test (CBC). V. Risks and Benefits: 1. Risks: This study poses no risk to the subjects. The investigators only use the result data of patients after participants have had their routine blood test; there is no need for patients to undergo additional blood draws. 2. Benefits: It will shorten the turnaround time for routine blood test results and share the workload of doctors in reviewing these results. VI. Privacy: All of participants information will be kept strictly confidential and will only be used for this scientific research.

NCT Number	NCT07607184
Lead Sponsor	Huashan Hospital Collaborators: Peking University First Hospital, The Fifth Affiliated Hospital of Wenzhou Medical University & Lishui Central Hospital
Conditions	Complete Blood Count Review
Enrollment	20,000 participants
Start Date	2026-05-14
Primary Completion	2027-08-31 (estimated)
Study Completion	2027-08-31 (estimated)
Updated on ClinicalTrials.gov	2026-05-28