Papillary Thyroid CancerNCT06316895
The Clinical Outcomes and Prediction of Thermal Ablation for Low-risk Papillary Thyroid Carcinoma
An observational study of Papillary Thyroid Cancer, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
1. To evaluate the clinical outcomes of ultrasound-guided thermal ablation and thyroid surgery for the treatment of papillary thyroid carcinoma; 2. To develop and validate a artificial intelligence model to predict the outcomes of ultrasound-guided thermal ablation in the treatment of papillary thyroid carcinoma; Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Papillary Thyroid Cancer
- What is being tested?
- thyroid surgery and ultrasound-guided thermal ablation
- Type of treatment
- Surgery or procedure
- How many people
- 3,772 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2024to 31 Dec 2029
- 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 low-risk papillary thyroid carcinoma who choose surgery or thermal ablation
Who may be able to join
- patients age between 18 and 80 year old, both sex
- papillary thyroid carcinoma confirmed by core-needle biopsy or fine-needle aspiration
- the largest diameter ≤2.0 cm
- no clinical or imaging evidences of extrathyroidal extension, lymph node metastasis and distant metastasis on ultrasound, nech and chest CT
- follow-up period ≥12 months,
Who cannot join
- patients with convincing evidence of aggressive papillary thyroid carcinoma or other type of thyroid cancer by biopsy
- history of neck radiation
- history of thyroid surgery
- coagulation disorder
- serious heart, respiratory, liver, or renal failure
- dysfunction of the vocal cord on the opposite side
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Clinical Outcomes and Artificial Intelligence Prediction Model of Ultrasound-guided Thermal Ablation for the Treatment of Low-risk Papillary Thyroid Carcinoma
- To evaluate the clinical outcomes of ultrasound-guided thermal ablation and thyroid surgery for the treatment of papillary thyroid carcinoma;
- To develop and validate a artificial intelligence model to predict the outcomes of ultrasound-guided thermal ablation in the treatment of papillary thyroid carcinoma;
- Conditions
- Papillary Thyroid Cancer
- Being tested
- thyroid surgery, ultrasound-guided thermal ablation
- Medical subject headings
- Thyroid Cancer, Papillary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thyroid surgeryProcedure or surgery
thyroid lobectomy
ultrasound-guided thermal ablationProcedure or surgery
radiofrequency ablation; microwave ablation or laser ablation
| Study group | Role | What they receive |
|---|---|---|
| surgery group | patients with low-risk papillary thyroid carcinoma who chose thyroid surgery Receives: Procedure: thyroid surgery | |
| ablation group | patients with low-risk papillary thyroid carcinoma who chose thermal ablation Receives: Procedure: ultrasound-guided thermal ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of disease progression
cervical lymph node metastases, recurrent tumors and persistent tumors
Measured: more than 5 year
Secondary outcomes (2)
Rate of complications
surgery or ablation complications
Measured: 1week
Rate of tumor disappearance
complete disappearance of ablated tumor on ultrasound and contrast-enhanced ultrasound
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2024
- Study start1 Apr 2024
- Primary completion1 Apr 2027 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Papillary Thyroid CancerStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe 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
- 3,772 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu-kun Luo, Chinese PLA General Hospital
- Investigators
- Yukun Luo, Study chair, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06316895
- Sponsor's protocol ID
- S2023-706
- Status last verified
- Mar 2026
- First submitted
- 16 Feb 2024
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Outcomes and Artificial Intelligence Prediction Model of Ultrasound-guided Thermal Ablation for the Treatment of Low-risk Papillary Thyroid Carcinoma
- ClinicalTrials.gov ID
- NCT06316895
- Acronym / sponsor ID
- S2023-706
- Conditions
- Papillary Thyroid Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,772 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 19 Mar 2024 (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.
- To evaluate the clinical outcomes of ultrasound-guided thermal ablation and thyroid surgery for the treatment of papillary thyroid carcinoma;
- To develop and validate a artificial intelligence model to predict the outcomes of ultrasound-guided thermal ablation in the treatment of papillary thyroid carcinoma;
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| surgery group | – | Procedure: thyroid surgerypatients with low-risk papillary thyroid carcinoma who chose thyroid surgery |
| ablation group | – | Procedure: ultrasound-guided thermal ablationpatients with low-risk papillary thyroid carcinoma who chose thermal ablation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with low-risk papillary thyroid carcinoma who choose surgery or thermal ablation
Key inclusion criteria (5 listed)
- patients age between 18 and 80 year old, both sex
- papillary thyroid carcinoma confirmed by core-needle biopsy or fine-needle aspiration
- the largest diameter ≤2.0 cm
- no clinical or imaging evidences of extrathyroidal extension, lymph node metastasis and distant metastasis on ultrasound, nech and chest CT
- follow-up period ≥12 months,
Key exclusion criteria (6 listed)
- patients with convincing evidence of aggressive papillary thyroid carcinoma or other type of thyroid cancer by biopsy
- history of neck radiation
- history of thyroid surgery
- coagulation disorder
- serious heart, respiratory, liver, or renal failure
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 |
|---|---|---|
| thyroid surgerythyroid lobectomy | Procedure or surgery | surgery group |
| ultrasound-guided thermal ablationradiofrequency ablation; microwave ablation or laser ablation | Procedure or surgery | ablation group |
Primary outcome
rate of disease progression
Time frame: more than 5 year
cervical lymph node metastases, recurrent tumors and persistent tumors
2 secondary outcomes
Rate of complications
Time frame: 1week
Rate of tumor disappearance
Time frame: 2 year
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 20 Mar 2026.
- Individual participant dataSharing planned: No
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Studies on Tumors of the Thyroid
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Active, not recruitingPhase 3
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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.
Yukun Luo study chair
Chinese PLA General Hospital
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 Papillary Thyroid Cancer, run by Chinese PLA General Hospital 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 5 inclusion and 6 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 20 Mar 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 Lin Yan, MD (13811237313 ext. 86, gemma-y@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of disease progression (time frame: more than 5 year). 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 20 Mar 2026.