Evaluation of an Artificial Intelligence-enabled Clinical Assistant to Support Thyroid Cancer Management
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
1 other identifier
interventional
76
1 country
2
Brief Summary
This study aims to evaluate the clinical feasibility of adopting artificial intelligence (AI)-based models to improve clinical management of thyroid cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2025
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 29, 2025
CompletedStudy Start
First participant enrolled
October 2, 2025
CompletedFirst Posted
Study publicly available on registry
November 18, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 30, 2027
July 21, 2026
July 1, 2026
1.5 years
September 29, 2025
July 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Efficiency
The time required to complete reviewing one set of clinical notes is compared between intervention and non-intervention groups
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
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
Study Arms (2)
AI-enabled clinical assistant
EXPERIMENTALParticipants 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 INTERVENTIONParticipants 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Consenting medical students
- Consenting clinicians who are directly involved in the care of thyroid cancer patients, including endocrine surgeons, endocrinologists, oncologists, and pathologists.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Department of Surgery, School of Clinical Medicine, The University of Hong Kong
Hong Kong, Hong Kong
School of Public Health, The University of Hong Kong
Hong Kong, Hong Kong
Related Publications (1)
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.
PMID: 40025285RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
King Ho Carlos Wong
School of Public Health The University of Hong Kong
- PRINCIPAL INVESTIGATOR
Man Him Matrix Fung
Department of Surgery, School of Clinical Medicine, The University of Hong Kong
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Honorary Associate Professor
Study Record Dates
First Submitted
September 29, 2025
First Posted
November 18, 2025
Study Start
October 2, 2025
Primary Completion (Estimated)
March 31, 2027
Study Completion (Estimated)
April 30, 2027
Last Updated
July 21, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
- Time Frame
- The IPD and supporting information will be available upon the completion of study (anticipated date as 30 April 2027) with results dissemination or publication, and will remain unending until required of removal.
- Access Criteria
- The IPD and supporting information will be available with results dissemination and publication as documents uploads or attachment. Anyone who has access to the articles will be able to access all the documents.
Only anonymized IPD used in results publications will be shared so that re-identification of individuals is not possible.