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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07607184
Enrollment
20000
Registered
2026-05-26
Start date
2026-05-14
Completion date
2027-08-31
Last updated
2026-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complete Blood Count Review

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. 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.

Interventions

OTHERLLM-Assisted Review Group

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).

Sponsors

Huashan Hospital
Lead SponsorOTHER
Peking University First Hospital
CollaboratorOTHER
Lishui hospital of Zhejiang University
CollaboratorUNKNOWN

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

* 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. Approved for inclusion by the Ethics Committee.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frame
Overall Report Turnaround Timeone year

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 29, 2026