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.
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.
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.
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.
Cohort
Prospective
Not listed
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.
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.
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.
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.
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.
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.
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