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NCT Number: NCT07607184

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Primary outcomes

  1. Overall Report Turnaround Time

    Time frame: one year

Sponsors and collaborators

Lead sponsor

Huashan Hospital

Other

Collaborators

  • Peking University First Hospital
  • The Fifth Affiliated Hospital of Wenzhou Medical University & Lishui Central Hospital

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 26, 2026
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.