Papillary Thyroid CancerNCT06325787
Image-guided Thermal Ablation vs. Lobectomy for Solitary Papillary Thyroid Microcarcinoma
A study testing thyroid lobectomy and image-guided thermal ablation in people with Papillary Thyroid Cancer, run by Chinese PLA General Hospital.
Trial summary
To evaluate the clinical outcomes of image-guided thermal ablation versus thyroid lobectomy for the treatment of papillary thyroid microcarcinoma 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?
- thyroid lobectomy and image-guided thermal ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,021 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2013to 31 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- solitary papillary thyroid carcinoma confirmed by fine-needle aspiration or core-needle biopsy;
- largest diameter ≤10 mm;
- no evidence of extrathyroidal extension( no signs of unsmooth thyroid capsule or involvement of the perithyroidal tissue) on ultrasound;
- no evidence of cervical lymph node metastasis on US or neck CT;
- no distant metastasis on chest CT;
- no history of neck irradiation.
Who cannot join
- (1)aggressive subtype of papillary thyroid microcarcinoma confirmed by biopsy(1); (2)multiple tumors; (3) incomplete data or lost follow-up
About this study
Official title: Long-term Comparison of Image-guided Thermal Ablation vs. Lobectomy for Solitary Papillary Thyroid Microcarcinoma: A Multicenter Retrospective Study
To evaluate the clinical outcomes of image-guided thermal ablation versus thyroid lobectomy for the treatment of papillary thyroid microcarcinoma
- Conditions
- Papillary Thyroid Cancer
- Being tested
- thyroid lobectomy, image-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 lobectomyProcedure or surgery
thyroid lobectomy
image-guided thermal ablationProcedure or surgery
radiofrequency ablation or microwave ablation or laser ablation
| Study group | Role | What they receive |
|---|---|---|
| lobectomy | Active comparator | thyroid lobectomy, is recommended as first-line treatment for papillary thyroid micraocarcinima Receives: Procedure: thyroid lobectomy |
| image-guided thermal ablation | Experimental | radiofrequency ablation or microwave ablation Receives: Procedure: image-guided thermal ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
disease progression
cervical lymph node metastases, recurrent tumors and persistent tumors
Measured: more than 5 years
disease-free survival
disease-free survival calculated from treatment initiation to disease progression or the last follow-up date
Measured: more than 5 years
Secondary outcomes (5)
complications
complications after surgery or ablation
Measured: 1 week
procedure time
Ablation procedure time was defined from US evaluation for the design of insertion way to treatment terminated. Lobectomy procedure time was defined from incision to closure, not including the anesthesia time.
Measured: 1 hour after treatment
cost
The ablation cost included preoperative examinations, treatment, local anesthesia and ablation needle costs. The lobectomy cost included preoperative examinations, treatment, general anesthesia, hospital bed, nursing and postoperative medication
Measured: 1 week
estimated blood loss
estimated blood loss after surgery or ablation
Measured: 1 hour
hospitalization
hospitalization for surgery or ablation
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study start1 May 2013
- Primary completion31 Jan 2017
- Study completion31 Jan 2024
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,021 participants (actual)
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06325787
- Sponsor's protocol ID
- S2021-211-02
- Status last verified
- Mar 2024
- First submitted
- 16 Mar 2024
- Last updated
- 25 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available because of the patients privacy.
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Comparison of Image-guided Thermal Ablation vs. Lobectomy for Solitary Papillary Thyroid Microcarcinoma: A Multicenter Retrospective Study
- ClinicalTrials.gov ID
- NCT06325787
- Acronym / sponsor ID
- S2021-211-02
- Conditions
- Papillary Thyroid Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,021 participants (actual)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 1 May 2013 (actual)
- Primary completion
- 31 Jan 2017 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 22 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 image-guided thermal ablation versus thyroid lobectomy for the treatment of papillary thyroid microcarcinoma
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lobectomy | Active comparator | Procedure: thyroid lobectomythyroid lobectomy, is recommended as first-line treatment for papillary thyroid micraocarcinima |
| image-guided thermal ablation | Experimental | Procedure: image-guided thermal ablationradiofrequency ablation or microwave ablation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- solitary papillary thyroid carcinoma confirmed by fine-needle aspiration or core-needle biopsy;
- largest diameter ≤10 mm;
- no evidence of extrathyroidal extension( no signs of unsmooth thyroid capsule or involvement of the perithyroidal tissue) on ultrasound;
- no evidence of cervical lymph node metastasis on US or neck CT;
- no distant metastasis on chest CT;
Key exclusion criteria (1 listed)
- (1)aggressive subtype of papillary thyroid microcarcinoma confirmed by biopsy(1); (2)multiple tumors; (3) incomplete data or lost follow-up
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 lobectomythyroid lobectomy | Procedure or surgery | lobectomy |
| image-guided thermal ablationradiofrequency ablation or microwave ablation or laser ablation | Procedure or surgery | image-guided thermal ablation |
Primary outcome
disease progression
Time frame: more than 5 years
cervical lymph node metastases, recurrent tumors and persistent tumors
disease-free survival
Time frame: more than 5 years
disease-free survival calculated from treatment initiation to disease progression or the last follow-up date
5 secondary outcomes
complications
Time frame: 1 week
procedure time
Time frame: 1 hour after treatment
cost
Time frame: 1 week
estimated blood loss
Time frame: 1 hour
hospitalization
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2024.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available because of the patients privacy.
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing thyroid lobectomy and image-guided thermal ablation in people with Papillary Thyroid Cancer, run by Chinese PLA General Hospital.
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 6 inclusion and 1 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: finished, as of the sponsor's last update on 25 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
disease progression (time frame: more than 5 years). The study lists 2 primary outcomes in all. 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 25 Mar 2024.