Papillary Thyroid Microcarcinoma
Conditions
Brief 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. 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.
Interventions
None listed
Sponsors
Xijing Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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).
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of lymph node metastasis confirmed by imaging and fine-needle aspiration within 10 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of lymph node metastasis confirmed by imaging and fine-needle aspiration within 5 years | 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) | 5 years | 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) | 10 years | 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. |
| Conversion rate from active surveillance to surgery | Up to 10 years | The proportion of participants initially managed with active surveillance who undergo surgical intervention during the study period. |
| Quality of life scores at 1, 3, 5, and 10 years | 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). |
| Overall survival rate at 10 years | 10 years | The proportion of participants who remain alive at 10 years from baseline, regardless of disease status or treatment modality. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events (AEs) and serious adverse events (SAEs) | Throughout the 10-year follow-up period | 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. |
Countries
China
Contacts
Primary ContactZhe Wang, Dr
Outcome results
None listed