Papillary Thyroid MicrocarcinomaPTMC-3SNCT07249125
Safety and Quality of Life of Three Treatment Strategies for Low-Risk Papillary Thyroid Microcarcinoma
An observational study of Papillary Thyroid Microcarcinoma, run by Xijing Hospital at 1 site in China.
Trial summary
This is a prospective observational patient registry study designed to evaluate the safety and quality of life associated with three treatment strategies for patients diagnosed with low-risk papillary thyroid microcarcinoma (PTMC): surgical resection, thermal ablation, and active surveillance. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Papillary Thyroid Microcarcinoma
- How many people
- 1,630 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2025to 1 Jun 2039
- How long will I take part?
- 10 Years
- 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: Adult patients diagnosed with low-risk papillary thyroid microcarcinoma (maximum diameter ≤1 cm), with no evidence of extrathyroidal extension, lymph node metastasis, or distant metastasis, who choose one of three management strategies: surgical resection, thermal ablation, or active surveillance.
Who may be able to join
- A single papillary thyroid carcinoma (PTC) lesion with a maximum diameter ≤ 1 cm confirmed by imaging.
- No evidence of extrathyroidal extension on imaging studies.
- No clinical or radiologic evidence of cervical lymph node metastasis.
- No evidence of distant metastasis.
- Histopathological confirmation of papillary thyroid carcinoma.
- The patient has provided written informed consent and agrees to select one of the predefined management strategies (surgical resection, thermal ablation, or active surveillance).
Who cannot join
- Ultrasound-confirmed tumor with a maximum diameter > 1 cm.
- Imaging findings (ultrasound/CT/MRI) suggestive of extrathyroidal extension.
- Tumor located adjacent to critical structures (e.g., trachea, esophagus, or recurrent laryngeal nerve) with possible invasion risk.
- History of thyroidectomy, radiofrequency/microwave/laser ablation, or radioactive iodine therapy.
- Failure to provide written informed consent.
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
Xijing hospital
Xi'an, Shaanxi, 710032
Zhe Wang, Dr, 029-84775271, wangzhe9263@163.com
About this study
Official title: A Prospective Registry Study Evaluating the Safety and Quality of Life of Three Treatment Strategies - Surgical Resection, Thermal Ablation, and Active Surveillance - for Patients With Low-Risk Papillary Thyroid Microcarcinoma
This is a prospective observational patient registry study designed to evaluate the safety and quality of life associated with three treatment strategies for patients diagnosed with low-risk papillary thyroid microcarcinoma (PTMC): surgical resection, thermal ablation, and active surveillance.
The study aims to collect standardized, real-world clinical data from participating centers. Patients will receive one of the three treatment strategies according to clinical judgment and personal preference. The study team will prospectively follow participants to record safety events, disease progression, and patient-reported quality of life outcomes.
By comparing the outcomes among the three treatment groups, this registry seeks to provide evidence to support personalized and evidence-based decision-making for the management of low-risk PTMC.
- Conditions
- Papillary Thyroid Microcarcinoma
- Medical subject headings
- Papillary Thyroid Microcarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Surgical Resection | Participants undergo standard thyroid surgery (lobectomy or total thyroidectomy) for low-risk papillary thyroid microcarcinoma. Outcomes on safety, complications, and postoperative quality of life are collected prospectively. | |
| Thermal Ablation | Participants receive minimally invasive thermal ablation, such as radiofrequency or microwave ablation, for papillary thyroid microcarcinoma. Data include procedural safety, ablation completeness, and patient-reported quality of life. | |
| Active Surveillance | Participants choose active surveillance instead of immediate intervention. Regular follow-up with ultrasound and clinical assessment is conducted to monitor tumor progression, safety events, and quality of life over time. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of lymph node metastasis confirmed by imaging and fine-needle aspiration within 10 years
The proportion of participants who show radiologic evidence of lymph node metastasis confirmed by fine-needle aspiration during 10 years of follow-up.
Measured: 10 years
Secondary outcomes (6)
Rate of lymph node metastasis confirmed by imaging and fine-needle aspiration within 5 years
The proportion of participants with imaging findings suggestive of lymph node metastasis confirmed by fine-needle aspiration at 5 years.
Measured: 5 years
Proportion of nodules with ≥3 mm increase in maximal diameter on ultrasound within 5 years (Active Surveillance group)
Among participants in the active surveillance group, the proportion of thyroid nodules showing an ultrasound-measured increase of at least 3 mm in maximal diameter within 5 years of follow-up.
Measured: 5 years
Proportion of nodules with ≥3 mm increase in maximal diameter on ultrasound within 10 years (Active Surveillance group)
Among active surveillance participants, the proportion of thyroid nodules showing an ultrasound-measured increase of 3 mm or more in maximal diameter within 10 years.
Measured: 10 years
Overall survival rate at 10 years
The proportion of participants who remain alive at 10 years from baseline, regardless of disease status or treatment modality.
Measured: 10 years
Conversion rate from active surveillance to surgery
The proportion of participants initially managed with active surveillance who undergo surgical intervention during the study period.
Measured: Up to 10 years
Quality of life scores at 1, 3, 5, and 10 years
Changes in patient-reported quality of life over time, evaluated using the Fear of Progression Questionnaire-Short Form (FoP-Q-SF) and the Thyroid Cancer-Specific Quality of Life Questionnaire (THYCA-QoL).
Measured: 1, 3, 5, and 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study start1 Dec 2025 (estimated)
- Primary completion31 Dec 2038 (estimated)
- Study completion1 Jun 2039 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Papillary Thyroid MicrocarcinomaStudies of the same condition, open and under way.
- More trials run by Xijing 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
- 1,630 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07249125
- Sponsor's protocol ID
- KY20252532-C-1
- Acronym
- PTMC-3S
- Status last verified
- Nov 2025
- First submitted
- 18 Nov 2025
- Last updated
- 25 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) will be available upon reasonable request after publication of the main results. Data will be shared with qualified researchers with a methodologically sound proposal, subject to approval by the study steering committee.
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Registry Study Evaluating the Safety and Quality of Life of Three Treatment Strategies - Surgical Resection, Thermal Ablation, and Active Surveillance - for Patients With Low-Risk Papillary Thyroid Microcarcinoma
- ClinicalTrials.gov ID
- NCT07249125
- Acronym / sponsor ID
- PTMC-3S / KY20252532-C-1
- Conditions
- Papillary Thyroid Microcarcinoma
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,630 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 31 Dec 2038 (estimated)
- Study completion
- 1 Jun 2039 (estimated)
- First posted
- 25 Nov 2025 (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.
This is a prospective observational patient registry study designed to evaluate the safety and quality of life associated with three treatment strategies for patients diagnosed with low-risk papillary thyroid microcarcinoma (PTMC): surgical resection, thermal ablation, and active surveillance.
The study aims to collect standardized, real-world clinical data from participating centers. Patients will receive one of the three treatment strategies according to clinical judgment and personal preference. The study team will prospectively follow participants to record safety events, disease progression, and patient-reported quality of life outcomes.
By comparing the outcomes among the three treatment groups, this registry seeks to provide evidence to support personalized and evidence-based decision-making for the management of low-risk PTMC.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Surgical Resection | – | –Participants undergo standard thyroid surgery (lobectomy or total thyroidectomy) for low-risk papillary thyroid microcarcinoma. Outcomes on safety, complications, and postoperative quality of life are collected prospectively. |
| Thermal Ablation | – | –Participants receive minimally invasive thermal ablation, such as radiofrequency or microwave ablation, for papillary thyroid microcarcinoma. Data include procedural safety, ablation completeness, and patient-reported quality of life. |
| Active Surveillance | – | –Participants choose active surveillance instead of immediate intervention. Regular follow-up with ultrasound and clinical assessment is conducted to monitor tumor progression, safety events, and quality of life over time. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients diagnosed with low-risk papillary thyroid microcarcinoma (maximum diameter ≤1 cm), with no evidence of extrathyroidal extension, lymph node metastasis, or distant metastasis, who choose one of three management strategies: surgical resection, thermal ablation, or active surveillance.
Key inclusion criteria (6 listed)
- A single papillary thyroid carcinoma (PTC) lesion with a maximum diameter ≤ 1 cm confirmed by imaging.
- No evidence of extrathyroidal extension on imaging studies.
- No clinical or radiologic evidence of cervical lymph node metastasis.
- No evidence of distant metastasis.
- Histopathological confirmation of papillary thyroid carcinoma.
Key exclusion criteria (5 listed)
- Ultrasound-confirmed tumor with a maximum diameter > 1 cm.
- Imaging findings (ultrasound/CT/MRI) suggestive of extrathyroidal extension.
- Tumor located adjacent to critical structures (e.g., trachea, esophagus, or recurrent laryngeal nerve) with possible invasion risk.
- History of thyroidectomy, radiofrequency/microwave/laser ablation, or radioactive iodine therapy.
- Failure to provide written informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of lymph node metastasis confirmed by imaging and fine-needle aspiration within 10 years
Time frame: 10 years
The proportion of participants who show radiologic evidence of lymph node metastasis confirmed by fine-needle aspiration during 10 years of follow-up.
6 secondary outcomes
Rate of lymph node metastasis confirmed by imaging and fine-needle aspiration within 5 years
Time frame: 5 years
Proportion of nodules with ≥3 mm increase in maximal diameter on ultrasound within 5 years (Active Surveillance group)
Time frame: 5 years
Proportion of nodules with ≥3 mm increase in maximal diameter on ultrasound within 10 years (Active Surveillance group)
Time frame: 10 years
Overall survival rate at 10 years
Time frame: 10 years
Conversion rate from active surveillance to surgery
Time frame: Up to 10 years
Quality of life scores at 1, 3, 5, and 10 years
Time frame: 1, 3, 5, and 10 years
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 25 Nov 2025.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) will be available upon reasonable request after publication of the main results. Data will be shared with qualified researchers with a methodologically sound proposal, subject to approval by the study steering committee.
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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.
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 Microcarcinoma, run by Xijing 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 6 inclusion and 5 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: opening soon, as of the sponsor's last update on 25 Nov 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 Zhe Wang, Dr (029-84775271, wangzhe9263@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of lymph node metastasis confirmed by imaging and fine-needle aspiration within 10 years (time frame: 10 years). 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 Nov 2025.