- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06316895
The Clinical Outcomes and Prediction of Thermal Ablation for Low-risk Papillary Thyroid Carcinoma
March 18, 2026 updated by: Yu-kun Luo, Chinese PLA General Hospital
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;
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
3772
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Lin Yan, MD
- Phone Number: 86 13811237313
- Email: gemma-y@163.com
Study Locations
-
-
-
Beijing, China
- Recruiting
- Chinese PLA General Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
patients with low-risk papillary thyroid carcinoma who choose surgery or thermal ablation
Description
Inclusion Criteria:
- 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,
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
surgery group
patients with low-risk papillary thyroid carcinoma who chose thyroid surgery
|
thyroid lobectomy
|
|
ablation group
patients with low-risk papillary thyroid carcinoma who chose thermal ablation
|
radiofrequency ablation; microwave ablation or laser ablation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
rate of disease progression
Time Frame: more than 5 year
|
cervical lymph node metastases, recurrent tumors and persistent tumors
|
more than 5 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rate of complications
Time Frame: 1week
|
surgery or ablation complications
|
1week
|
|
Rate of tumor disappearance
Time Frame: 2 year
|
complete disappearance of ablated tumor on ultrasound and contrast-enhanced ultrasound
|
2 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Yukun Luo, Chinese PLA General Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2024
Primary Completion (Estimated)
April 1, 2027
Study Completion (Estimated)
December 31, 2029
Study Registration Dates
First Submitted
February 16, 2024
First Submitted That Met QC Criteria
March 16, 2024
First Posted (Actual)
March 19, 2024
Study Record Updates
Last Update Posted (Actual)
March 20, 2026
Last Update Submitted That Met QC Criteria
March 18, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Endocrine System Diseases
- Neoplasms by Site
- Neoplasms
- Neoplasms by Histologic Type
- Thyroid Neoplasms
- Endocrine Gland Neoplasms
- Head and Neck Neoplasms
- Neoplasms, Glandular and Epithelial
- Adenocarcinoma
- Carcinoma
- Thyroid Diseases
- Adenocarcinoma, Papillary
- Thyroid Cancer, Papillary
- Surgical Procedures, Operative
- Urologic Surgical Procedures
- Urogenital Surgical Procedures
- Urologic Surgical Procedures, Male
- Prostatectomy
- Transurethral Resection of Prostate
Other Study ID Numbers
- S2023-706
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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