NCT02952612Unknown不适用
Active Surveillance of Papillary Thyroid Microcarcinoma (PTMC) in Catholic Medical Center
Dong Jun Lim1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2016年10月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Progression of papillary thyroid microcarcinoma
研究概览
简要总结
Papillary thyroid microcarcinoma are small thyroid cancer measuring 1cm or less. Most of this tumor are not palpable and are identified either through pathologic examination or from imaging modalities, such as CT scan or thyroid sono. Active surveillance of papillary microcarcinoma is to observe thyroid papillary cancer without immediate surgical approach. The purpose of this study is to understand more about the characteristics of papillary microcarcinoma, which has been known for "the cancer slowly progression"
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •< 1 cm solitary nodule
- •Surrounded by ≥ 2 mm normal thyroid parenchyma
- •Subcapsular locations not adjacent to surrounding structures, recurrent laryngeal nerve, trachea, or carotid artery
- •No evidence of invasion to surrounding structures, recurrent laryngeal nerve, trachea or carotid artery
- •No extrathyroidal extension
- •Clinically N0 and Clinically M0
- •Combined severe comorbidities or Inoperable condition (optional)
- •No wish to surgery and Willingness to accept active surveillance
- •No history of radiotherapy on head and neck area
- •Accepted by the Board of Thyroid Cancer Meeting
排除标准
- •≥ 1 cm nodule and multifocal nodules regardless of size
- •Papillary thyroid carcinoma variants associated with poor prognosis (tall cell variant, columnar variant, hobnail variant) or other types of thyroid cancer)
- •Subcapsular locations adjacent to surrounding structures, recurrent laryngeal nerve, trachea or carotid artery
- •Evidence of invasion to surrounding structures, recurrent laryngeal nerve, trachea or carotid artery
- •Extrathyroidal extension
- •Any of N1 or M1
- •Documented increase in size according to America Thyroid Association (ATA) guideline in a previously confirmed Papillary thyroid microcarcinoma
- •< 18 years
- •Not willing to accept observational active surveillance approach
结局指标
主要结局
Progression of papillary thyroid microcarcinoma
时间窗: 5 years after enrollment
Using thyroid sonography, check any changes in size and shape of papillary thyroid microcarcinoma
次要结局
未报告次要终点
研究者
Dong Jun Lim
Professor
Seoul St. Mary's Hospital
研究点 (1)
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