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Enrolling by Invitation

NCT Number: NCT07234539

Evaluation of an Artificial Intelligence-enabled Clinical Assistant to Support Thyroid Cancer Management

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Surgery, School of Clinical Medicine, The University of Hong Kong, Hong Kong

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

AI-enabled clinical assistant

Other

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.

Primary outcomes

  1. Efficiency

    Time frame: 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

Secondary outcomes

  1. Accuracy of Cancer Staging and Risk Stratification by Participants Compared with Ground Truth across Intervention and Non-intervention Groups

    Time frame: Between intervention group and non-intervention group. Cross-over in 4-26 weeks

    The study will compare the accuracy of cancer staging and risk category assessed by the participants across the intervention group with AI assitance and non-intervention group without AI asssitance.

    The participants will review the clinical notes and assess the cancer staging and risk category for each thyroid cancer patient with or without the AI assistant. Participant provided assessments will be compared against the ground truth established by the clinical investigators of the study to guage the accuracy which is quantified as the percentage of correctly graded cancer staging and risk stratification. The accuracy will be compared between the intervention group and non-intervention groups using t-tests to evaluate the clinical impact of the AI assistant.

  2. Participants' Confidence in Cancer Staging and Risk Stratification as Assessed by a 0-10 Scale Questionnaire

    Time frame: Between intervention group and non-intervention group. Cross-over in 4-26 weeks

    The study will compare the participants' confidence in grading cancer staging and risk category between the intervention group with AI assistance and non-intervention group without AI-assistance.

    After evaluating each thyroid cancer case for providing cancer staging and risk category, participants will complete a short questionnaire rating their confidence in providing their assessments on a scale from 0 (lowest) to 10 (hightest). Meanw confidence score will be compared between the intervention group and non-intervention group to evaluate the clinical impact of the AI assitant.

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Collaborators

  • Innovation and Technology Commission, Hong Kong

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Nov 18, 2025
Registry last updated
Jul 21, 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.

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