Safety and Quality of Life of Three Treatment Strategies for Low-Risk Papillary Thyroid Microcarcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Papillary Thyroid Microcarcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Primary outcome measures
- Rate of lymph node metastasis confirmed by imaging and fine-needle aspiration within 10 years [Time frame: 10 years]
Secondary outcome measures (6)
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Xijing hospital — Xi'an
Identifiers
NCT: NCT07249125 · KY20252532-C-1