Active Surveillance on Papillary Thyroid Microcarcinoma
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,211
- 试验地点
- 1
- 主要终点
- Rate of Progression of Thyroid Papillary Microcarcinoma
研究概览
简要总结
The study is a multi-center prospective cohort study of active surveillance in papillary thyroid cancer with low risk. The purpose of the study is to observe natural course of low risk papillary thyroid cancer in Korean population, and comparison of prognosis between active surveillance group and conventional surgery group. Patient will be well informed about their choice of active surveillance or surgery.
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
- •who agreed to the agreement form
- •who is older than 18 years old
- •who was diagnosed by fine needle aspiration or needle biopsy of Bethesda category V or VI
- •whose thyroid cancer is smaller than 1 cm length
排除标准
- •who cannot routinely follow-up according to the study schedule
- •who was diagnosed by fine needle aspiration or needle biopsy of Bethesda category I, II, III, or IV.
- •who have hyperthyroidism which needs treatment
结局指标
主要结局
Rate of Progression of Thyroid Papillary Microcarcinoma
时间窗: 5 years
rate of progression: tumor size increase of ≥3 mm in at least one dimension, tumor size increase of ≥2 mm in at least two dimensions, suspected organ involvement during the follow-up, such as trachea, esophagus, nerves, vessels, or muscles in imaging study including high-resolution ultrasonography, or pathological diagnosis of lymph node/distant metastasis
次要结局
- Comparison of Progression Rate between Active Surveillance and Surgery Group(5 years)
研究者
Young Joo Park
Professor
Seoul National University Hospital