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

NCT07607184 | Not Yet Recruiting

• 1 other identifier: KY2026-084
• Study Type: observational
• Target: 20,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

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. 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. 2.Benefits: It will shorten the turnaround time for routine blood test results and share the workload of doctors in reviewing these results.

Conditions

Complete Blood Count Review

Outcome Measures

Primary Outcomes (1)

• Overall Report Turnaround Time

  one year

Study Arms (2)

LLM-Assisted Review Group

Other: LLM-Assisted Review Group

Standard Manual Review Group

Interventions

LLM-Assisted Review Group OTHER

This study introduces an intelligent auxiliary review system based on a medical Large Language Model (LLM), aimed at optimizing the traditional CBC report review process. The core functions and intervention mechanisms are as follows: Multi-source Data Integration: The system integrates seamlessly with the Laboratory Information System (LIS) to automatically retrieve patient demographics (age, sex), current CBC indices, historical results, and clinical diagnoses. Deep Analysis and Anomaly Detection: Unlike traditional rule-based auto-verification, this system leverages the reasoning capability of LLMs to perform multidimensional clinical logic checks. It identifies out-of-range values and interprets their clinical significance by combining them with patient history (e.g., distinguishing physiological fluctuations from pathological changes).

LLM-Assisted Review Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study subjects were consecutive individuals undergoing routine blood tests at each center, with no restrictions on gender or age. After inclusion, samples entered the corresponding review process based on the study week, with preliminary and secondary reviews conducted by predefined workflows and qualified personnel, respectively.

You may qualify if:

• Subjects who underwent routine blood tests in the outpatient, emergency, or inpatient departments of the participating centers during the study period.
• Corresponding samples must have complete instrument results, review trails, and report timestamp records.

You may not qualify if:

• Samples collected during periods of instrument malfunction or interface transmission anomalies.
• Missing key research data, particularly samples where the final review conclusion or key timestamps cannot be confirmed.
• Subjects or their legal representatives explicitly refuse to participate in the study.

Sponsors & Collaborators

• Huashan Hospital: lead
• Peking University First Hospital: collaborator
• Lishui hospital of Zhejiang University: collaborator

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Department of Laboratory Medicine

Study Record Dates

• First Submitted: May 19, 2026
• First Posted: May 26, 2026
• Study Start: May 14, 2026
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: May 28, 2026

Record last verified: 2026-05