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临床试验/NCT07234539
NCT07234539Enrolling By Invitation不适用

A Randomized Controlled Trial to Evaluate an Artificial Intelligence-enabled Clinical Assistant Leveraging Large Language Models for Thyroid Cancer Staging and Risk Stratification Among Medical Students and Clinicians

The University of Hong Kong2 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2025年10月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
76
试验地点
2
主要终点
Efficiency

研究概览

简要总结

This study aims to evaluate the clinical feasibility of adopting artificial intelligence (AI)-based models to improve clinical management of thyroid cancer.

详细描述

With recent advancements in technology, AI has become widely applicable to visual text recognition in clinical settings. AI-powered text recognition is emerging as a highly efficient, sustainable, and cost-effective tool for decision making and personalised medicine. Numerous studies have employed natural language processing (NLP) algorithms, particularly large language models (LLMs), to convert unstructured free-text from clinical consultation notes within electronic health records (EHR) into structured data, thus enriching individual clinical profiles in the EHR databases. Over time, these AI models have continuously improved their predictive accuracy and performance through self-learning (or unsupervised learning). While AI models had made a significant impact in oncology practices overseas, their utility for text recognition in oncology remains limited in Hong Kong. This proposed study aims to evaluate the clinical feasibility of adopting AI-based models to improve time efficiency, accuracy, and end-users' confidence in diagnostic assessment and risk prediction, compared against traditional workflows without AI assistant for thyroid cancer management.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Consenting medical students
  • •Consenting clinicians who are directly involved in the care of thyroid cancer patients, including endocrine surgeons, endocrinologists, oncologists, and pathologists.

排除标准

  • •Medical students and clinicians who had reviewed the clinical notes or were involved in the processing of the clinical notes prior to the commencement of trial

研究组 & 干预措施

Manural chart review

No Intervention

Participants will provide the caner staging and risk category of each thyroid cancer patient as well as the participants' confidence for the above diagnostic assessments with manual chart review.

AI-enabled clinical assistant

Experimental

Participants will provide the caner staging and risk category of each thyroid cancer patient as well as the participants' confidence for the above diagnostic assessments with AI-enabled clinical assistant as the intervention. The AI assistant is powered by LLMs and comprises a clinical dashboard. The clinical dashboard displays the original clinical notes and summarizes cancer staging and risk category of each thyroid cancer patient generated from the backend processing of the clinical assistant. Supporting evidence from original clinical notes is also highlighted for participants' verification.

干预措施: AI-enabled clinical assistant (Other)

结局指标

主要结局

Efficiency

时间窗: Between intervention group and non-intervention group. Cross-over in 4-26 weeks

The time required to complete reviewing one set of clinical notes is compared between intervention and non-intervention groups

次要结局

  • Accuracy of Cancer Staging and Risk Stratification by Participants Compared with Ground Truth across Intervention and Non-intervention Groups(Between intervention group and non-intervention group. Cross-over in 4-26 weeks)
  • Participants' Confidence in Cancer Staging and Risk Stratification as Assessed by a 0-10 Scale Questionnaire(Between intervention group and non-intervention group. Cross-over in 4-26 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Carlos King-Ho Wong

Honorary Associate Professor

The University of Hong Kong

研究点 (2)

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