Prospective Active Surveillance Versus Surgery in Thyroid Papillary Microcarcinoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Quality of life in patient who received either surgery or follow up
研究概览
简要总结
The primary objective of this study is to evaluate the outcome of two treatment approaches (immediate surgery or close follow-up) in patients with papillary thyroid microcarcinoma (mPTc) .
详细描述
The primary objective of this study is to evaluate the outcome of two treatment approaches (immediate surgery or close follow-up) in patients with papillary thyroid microcarcinoma (mPTc) .
A further objective is to identify events associated with high risk of local recurrence and distant metastases.
Patients will be randomized to surgery or active surveillance. Patients who refuse the randomization process will be followed according to the treatment choice according to clinical practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Age >or =18
- •Suspicious nodule < or = or 13 mm in the maximum size of thyroid ultrasound (not older than 3 months after the screening visit)
- •Cytology consistent with the TIR4 or TIR 5 class
- •Sieric TSH in th standard range (with or without levo-tyroxin therapy)
- •Normal string motility to fibrolaringoscopy
- •Written informed consent
排除标准
- •Ultrasound evidence of suspicious lump located on the posterior side of the lobe close to neurogene structures
- •Calcitonin increase above normal levels
- •Clinical or instrumental evidence of locoregional lymph node metastases (central or laterocervical compartment) or remote
- •any Contraindications to surgery
结局指标
主要结局
Quality of life in patient who received either surgery or follow up
时间窗: 36 months
EORTC QLQ-C30, a quality of life questionnaires, composed by 30 items graded from1 (not at all) to 4 (very much) within 1 year from the diagnosis
次要结局
- Quality of life in patient who received either surgery or follow up(36 months)
- Compare the two strategies in terms of anxiety/depression(36 months)
- Compare the two strategies in terms of adverse events(36 months)