Thyroid NoduleNCT07488325
Multimodal Assessment of Malignancy in Atypia of Undetermined Significance in Thyroid Nodules Using Ultrasound and Cytology Whole-Slide Images
An observational study of Thyroid Nodule, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial summary
The prospective study aim to develop a multimodal deep learning model that integrates ultrasound images and cytological whole-slide images for more accurate malignant risk prediction of Bethesda III thyroid nodules. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Thyroid Nodule
- What is being tested?
- Histopathology or cytopathology.
- How many people
- 396 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2026to 15 Jul 2026
- Phase
- Observational
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a Bethesda Ⅲ thyroid nodule
Who may be able to join
- (a) Patients who underwent fine-needle aspiration of thyroid nodules and received a cytological diagnosis of Bethesda Ⅲ.
- (b) Patients who subsequently underwent thyroid surgery with a definitive histopathological diagnosis of benign or malignant lesions,.
- (c) Availability of at least one ultrasound image acquired prior to surgery.
Who cannot join
- (a) Patients without confirmation by surgical pathology,.
- (b) Patients without any available or usable ultrasound images.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Xinmin Xiao, B.S. contact
China1 site, 1 recruiting
- Recruiting
No. 33 Yingfeng Road, Haizhu District, Guangzhou City, Guangdong Province, Sun Yat-sen Memorial Hospital
Guangzhou, Guangzhou, 510288
Jingliang Ruan, Ph.D., +8613694202230, ruanjl3@mail.sysu.edu.cn
Xinmin Xiao, B.S., +8618420058253, 1124507651@qq.com
About this study
The prospective study aim to develop a multimodal deep learning model that integrates ultrasound images and cytological whole-slide images for more accurate malignant risk prediction of Bethesda III thyroid nodules.
Read the detailed description
Objectives: To develop a multimodal deep learning model that integrates ultrasound images and cytological whole-slide images for more accurate malignant risk prediction of Bethesda III thyroid nodules.
Materials and Methods: A ultrasound model, a cytology model, and a fusion model were constructed in this single-center retrospective diagnostic accuracy test. Consecutive patients with Bethesda III thyroid nodules who underwent conventional US examination and fine-needle aspirations were included between January 2016 and December 2024 in Sun Yat-sen Memorial Hospital, Sun Yat-sen University. The reference standard was postoperative histopathology or BRAFV600E mutation. Receiver operating characteristic curve analysis was used to evaluate the diagnostic performance, and decision curve analysis was used to assess the clinical utility.
- Conditions
- Thyroid Nodule
- Being tested
- Histopathology or cytopathology.
- Keywords
- Thyroid Nodule, Atypia of Undetermined Significance, Multimodal Deep Learning, Ultrasound, Cytology Whole-Slide Image
- Medical subject headings
- Thyroid Nodule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Histopathology or cytopathology.Other
This is a observation stufy.
| Study group | Role | What they receive |
|---|---|---|
| Benign thyroid nodule | Confirmed by histopathology. Receives: Other: Histopathology or cytopathology. | |
| Malignant thyroid nodule | Confirmed by histopathology. Receives: Other: Histopathology or cytopathology. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological diagnosis.
WHO guidelines.
Measured: One month after the surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2026
- Study start1 Mar 2026
- Primary completion30 Jun 2026 (estimated)
- Study completion15 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid NoduleStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 396 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jingliang Ruan, Ph.D., Principal investigator, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07488325
- Sponsor's protocol ID
- SYSEC-AF-SW09-06.0
- Status last verified
- Mar 2026
- First submitted
- 10 Mar 2026
- Last updated
- 1 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Assessment of Malignancy in Atypia of Undetermined Significance in Thyroid Nodules Using Ultrasound and Cytology Whole-Slide Images
- ClinicalTrials.gov ID
- NCT07488325
- Acronym / sponsor ID
- SYSEC-AF-SW09-06.0
- Conditions
- Thyroid Nodule
- Keywords
- Thyroid Nodule, Atypia of Undetermined Significance, Multimodal Deep Learning, Ultrasound, Cytology Whole-Slide Image
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 396 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 15 Jul 2026 (estimated)
- First posted
- 23 Mar 2026 (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.
The prospective study aim to develop a multimodal deep learning model that integrates ultrasound images and cytological whole-slide images for more accurate malignant risk prediction of Bethesda III thyroid nodules.
Detailed description
Objectives: To develop a multimodal deep learning model that integrates ultrasound images and cytological whole-slide images for more accurate malignant risk prediction of Bethesda III thyroid nodules.
Materials and Methods: A ultrasound model, a cytology model, and a fusion model were constructed in this single-center retrospective diagnostic accuracy test. Consecutive patients with Bethesda III thyroid nodules who underwent conventional US examination and fine-needle aspirations were included between January 2016 and December 2024 in Sun Yat-sen Memorial Hospital, Sun Yat-sen University. The reference standard was postoperative histopathology or BRAFV600E mutation. Receiver operating characteristic curve analysis was used to evaluate the diagnostic performance, and decision curve analysis was used to assess the clinical utility.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Benign thyroid nodule | – | Other: Histopathology or cytopathology.Confirmed by histopathology. |
| Malignant thyroid nodule | – | Other: Histopathology or cytopathology.Confirmed by histopathology. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a Bethesda Ⅲ thyroid nodule
Key inclusion criteria (3 listed)
- (a) Patients who underwent fine-needle aspiration of thyroid nodules and received a cytological diagnosis of Bethesda Ⅲ.
- (b) Patients who subsequently underwent thyroid surgery with a definitive histopathological diagnosis of benign or malignant lesions,.
- (c) Availability of at least one ultrasound image acquired prior to surgery.
Key exclusion criteria (2 listed)
- (a) Patients without confirmation by surgical pathology,.
- (b) Patients without any available or usable ultrasound images.
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 |
|---|---|---|
| Histopathology or cytopathology.This is a observation stufy. | Other | Benign thyroid nodule, Malignant thyroid nodule |
Primary outcome
Pathological diagnosis.
Time frame: One month after the surgery.
WHO guidelines.
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 1 Apr 2026.
- Individual participant dataSharing planned: Undecided
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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.
Xinmin Xiao, B.S. contact
Jingliang Ruan, Ph.D. principal investigator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid Nodule, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
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 3 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
Contact Jingliang Ruan, Ph.D. (+8613694202230, ruanjl3@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological diagnosis. (time frame: One month after the surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Apr 2026.