Papillary Thyroid CancerNCT06733740
Ultrasound-guided Thermal Ablation for Papillary Thyroid Carcinoma
An observational study of Papillary Thyroid Cancer, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
To evaluate long-term outcomes of ultrasound-guided thermal ablation for the treatment of papillary thyroid carcinoma Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Papillary Thyroid Cancer
- What is being tested?
- ultrasound-guided thermal ablation
- Type of treatment
- Surgery or procedure
- How many people
- 3,000 participants
- Where
- 1 siteChina
- Study dates
- 10 Dec 2024to 31 Dec 2030
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with papillary thyroid carcinoma who refuse surgery or active surveillance and choose 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, neck 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
- 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.
China1 site, 1 recruiting
- Recruiting
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
Lin Yan
About this study
Official title: The Clinical Outcomes of Ultrasound-guided Thermal Ablation for the Treatment of Papillary Thyroid Carcinoma: A Multicenter Study
To evaluate long-term outcomes of ultrasound-guided thermal ablation for the treatment of papillary thyroid carcinoma
Read the detailed description
To evaluate and predict long-term clinical outcomes of ultrasound-guided thermal ablation for the treatment of papillary thyroid carcinoma by a multicenter study
- Conditions
- Papillary Thyroid Cancer
- Being tested
- 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.
ultrasound-guided thermal ablationProcedure or surgery
ultrasound-guided thermal ablation to treat tumor
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 confirmed by pathology
Measured: through study completion, an average of 6 months
Secondary outcomes (5)
Rate of complications
complications of ablation
Measured: 1 week
Rate of tumor disappearance
complete disappearance of ablated tumor on ultrasound and contrast-enhanced ultrasound
Measured: through study completion, an average of 6 months
Rate of volume reduction
volume reduction of tumor after ablation on ultrasound and contrast-enhanced ultrasound
Measured: through study completion, an average of 6 months
rate of change of thyroid function
thyroid function test, including free triiodothyronine, free thyroxine, thyroid stimulating hormone, thyroid peroxidase antibody and anti-thyroglobulin antibodies
Measured: through study completion, an average of 6 months
rate of delayed surgery
patients underwent surgery after ablation because of anxiety
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2024
- Study start10 Dec 2024
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2030 (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
- 3,000 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, Principal investigator, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06733740
- Sponsor's protocol ID
- 2024-655
- Status last verified
- Feb 2025
- First submitted
- 6 Dec 2024
- Last updated
- 14 Feb 2025
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Outcomes of Ultrasound-guided Thermal Ablation for the Treatment of Papillary Thyroid Carcinoma: A Multicenter Study
- ClinicalTrials.gov ID
- NCT06733740
- Acronym / sponsor ID
- 2024-655
- Conditions
- Papillary Thyroid Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 10 Dec 2024 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 13 Dec 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 long-term outcomes of ultrasound-guided thermal ablation for the treatment of papillary thyroid carcinoma
Detailed description
To evaluate and predict long-term clinical outcomes of ultrasound-guided thermal ablation for the treatment of papillary thyroid carcinoma by a multicenter study
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with papillary thyroid carcinoma who refuse surgery or active surveillance and choose 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, neck and chest CT
- follow-up period ≥12 months
Key exclusion criteria (4 listed)
- patients with convincing evidence of aggressive papillary thyroid carcinoma or other type of thyroid cancer by biopsy
- history of neck radiation
- coagulation disorder, serious heart, respiratory, liver, or renal failure
- dysfunction of the vocal cord on the opposite side
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 |
|---|---|---|
| ultrasound-guided thermal ablationultrasound-guided thermal ablation to treat tumor | Procedure or surgery | – |
Primary outcome
rate of disease progression
Time frame: through study completion, an average of 6 months
cervical lymph node metastases, recurrent tumors and persistent tumors confirmed by pathology
5 secondary outcomes
Rate of complications
Time frame: 1 week
Rate of tumor disappearance
Time frame: through study completion, an average of 6 months
Rate of volume reduction
Time frame: through study completion, an average of 6 months
rate of change of thyroid function
Time frame: through study completion, an average of 6 months
rate of delayed surgery
Time frame: through study completion, an average of 1 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 14 Feb 2025.
- Individual participant dataSharing planned: No
Related trials for Papillary Thyroid Cancer
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Definition of Mutational Profile of Papillary Thyroid Tumors by Mass-ARRAY
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Serum Treg/Th17-Related Cytokines and Systemic Inflammatory Indices in Differentiated Thyroid Cancer
Differentiated Thyroid Cancer (DTC), Papillary Thyroid Carcinoma
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Studies on Tumors of the Thyroid
Hurthle Cell Thyroid Cancer, Tall Cell Variant Thyroid Cancer
Active, not recruitingPhase 3
A Study of Cabozantinib Compared With Placebo in Subjects With Radioiodine-refractory Differentiated Thyroid Cancer Who Have Progressed After Prior Vascular Endothelial Growth Factor Receptor (VEGFR) -Targeted Therapy
Differentiated Thyroid Cancer
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 principal investigator
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 4 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 14 Feb 2025. 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: through study completion, an average of 6 months). 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 14 Feb 2025.