Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 5 years |
| Proportion of nodules with ≥3 mm increase in maximal diameter on ultrasound within 5 years (Active Surveillance group) |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events (AEs) and serious adverse events (SAEs) | Number and percentage of participants experiencing any study-related adverse events or serious adverse events, collected throughout the study and categorized by severity and relationship to treatment type. | Throughout the 10-year follow-up period |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhe Wang, Dr | Contact | 029-84775271 | wangzhe9263@163.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xijing hospital | Xi'an | Shaanxi | 710032 | China |
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.
Starting 6 months after main publication; available for at least 5 years thereafter.
Researchers may request access through the corresponding author by submitting a proposal and a data use agreement.
Not provided
Not provided
| ID | Term |
|---|---|
| C563277 | Papillary Thyroid Microcarcinoma |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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. |
| 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. | 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. | 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. | 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). | 1, 3, 5, and 10 years |