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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,630
- 试验地点
- 1
- 主要终点
- Rate of lymph node metastasis confirmed by imaging and fine-needle aspiration within 10 years
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
结局指标
主要结局
Rate of lymph node metastasis confirmed by imaging and fine-needle aspiration within 10 years
时间窗: 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.
次要结局
- Overall survival rate at 10 years(10 years)
- Conversion rate from active surveillance to surgery(Up to 10 years)
- Rate of lymph node metastasis confirmed by imaging and fine-needle aspiration within 5 years(5 years)
- Proportion of nodules with ≥3 mm increase in maximal diameter on ultrasound within 5 years (Active Surveillance group)(5 years)
- Proportion of nodules with ≥3 mm increase in maximal diameter on ultrasound within 10 years (Active Surveillance group)(10 years)
- Quality of life scores at 1, 3, 5, and 10 years(1, 3, 5, and 10 years)