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 Type
OBSERVATIONAL
Enrollment
1,630
Xijing hospital
Xi'an, Shaanxi, China
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.
Time frame: 10 years
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 1, 3, 5, and 10 years
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