Thyroid CancerNCT07234539
Evaluation of an Artificial Intelligence-enabled Clinical Assistant to Support Thyroid Cancer Management
A study testing AI-enabled clinical assistant in people with Thyroid Cancer and Large Language Models, run by The University of Hong Kong at 2 sites in Hong Kong.
Trial summary
This study aims to evaluate the clinical feasibility of adopting artificial intelligence (AI)-based models to improve clinical management of thyroid cancer. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Thyroid Cancer, Large Language Models
- What is being tested?
- AI-enabled clinical assistant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 2 sitesHong Kong
- Study dates
- 2 Oct 2025to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Consenting medical students
- Consenting clinicians who are directly involved in the care of thyroid cancer patients, including endocrine surgeons, endocrinologists, oncologists, and pathologists.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong2 sites
Department of Surgery, School of Clinical Medicine, The University of Hong Kong
Hong Kong
School of Public Health, The University of Hong Kong
Hong Kong
About this study
Official 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
This study aims to evaluate the clinical feasibility of adopting artificial intelligence (AI)-based models to improve clinical management of thyroid cancer.
Read the detailed description
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.
- Conditions
- Thyroid Cancer, Large Language Models
- Being tested
- AI-enabled clinical assistant
- Keywords
- Thyroid Cancer, large language models, LLMs, natural language processing, NLP
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-enabled clinical assistantOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: AI-enabled clinical assistant |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficiency
The time required to complete reviewing one set of clinical notes is compared between intervention and non-intervention groups
Measured: Between intervention group and non-intervention group. Cross-over in 4-26 weeks
Secondary outcomes (2)
Accuracy of Cancer Staging and Risk Stratification by Participants Compared with Ground Truth across Intervention and Non-intervention Groups
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.
Measured: 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
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.
Measured: Between intervention group and non-intervention group. Cross-over in 4-26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study start2 Oct 2025
- Primary completion31 Mar 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Thyroid CancerStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Innovation and Technology Commission, Hong Kong
- Responsible party
- Principal investigator, Dr. Carlos King-Ho Wong, The University of Hong Kong
- Investigators
- King Ho Carlos Wong, Principal investigator, School of Public Health The University of Hong KongMan Him Matrix Fung, Principal investigator, Department of Surgery, School of Clinical Medicine, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07234539
- Sponsor's protocol ID
- UW24-319-RCT
- Status last verified
- Jul 2026
- First submitted
- 29 Sep 2025
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Only anonymized IPD used in results publications will be shared so that re-identification of individuals is not possible.
Publications
Fung MMH, Tang EHM, Wu T, Luk Y, Au ICH, Liu X, Lee VHF, Wong CK, Wei Z, Cheng WY, Tai ICY, Ho JWK, Wong JWH, Lang BHH, Leung KSM, Wong ZSY, Wu JT, Wong CKH. Developing a named entity framework for thyroid cancer staging and risk level classification using large language models. NPJ Digit Med. 2025 Mar 1;8(1):134. doi: 10.1038/s41746-025-01528-y.
PubMed 40025285
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07234539
- Acronym / sponsor ID
- UW24-319-RCT
- Conditions
- Thyroid Cancer, Large Language Models
- Keywords
- Thyroid Cancer, large language models, LLMs, natural language processing, NLP
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Innovation and Technology Commission, Hong Kong
- Study start
- 2 Oct 2025 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 18 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the clinical feasibility of adopting artificial intelligence (AI)-based models to improve clinical management of thyroid cancer.
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AI-enabled clinical assistant | Experimental | Other: AI-enabled clinical assistantParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Consenting medical students
- Consenting clinicians who are directly involved in the care of thyroid cancer patients, including endocrine surgeons, endocrinologists, oncologists, and pathologists.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI-enabled clinical assistantParticipants 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. | Other | AI-enabled clinical assistant |
Primary outcome
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
2 secondary outcomes
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Results publication: PubMed 40025285Fung MMH, Tang EHM, Wu T, Luk Y, Au ICH, Liu X, Lee VHF, Wong CK, Wei Z, Cheng WY, Tai ICY, Ho JWK, Wong JWH, Lang BHH, Leung KSM, Wong ZSY, Wu JT, Wong CKH. Developing a named entity framework for thyroid cancer staging and risk level classification using large language models. NPJ Digit Med. 2025 Mar 1;8(1):134. doi: 10.1038/s41746-025-01528-y.
- Individual participant dataSharing planned: Yes. Only anonymized IPD used in results publications will be shared so that re-identification of individuals is not possible.
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Thyroid Cancer
Not yet recruitingObservational study
Serum Treg/Th17-Related Cytokines and Systemic Inflammatory Indices in Differentiated Thyroid Cancer
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
King Ho Carlos Wong principal investigator
School of Public Health The University of Hong Kong
Man Him Matrix Fung principal investigator
Department of Surgery, School of Clinical Medicine, The University of Hong Kong
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI-enabled clinical assistant in people with Thyroid Cancer and Large Language Models, run by The University of Hong Kong at 2 sites in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficiency (time frame: Between intervention group and non-intervention group. Cross-over in 4-26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07234539, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.