Molecular Testing to Direct Extent of Initial Thyroid Surgery
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Number of patients who require completion thyroidectomy for aggressive histology features
研究概览
简要总结
The research study consists of the participant agreeing to 1) the use of preoperative molecular testing (ThyroSeq) to guide extent of initial surgery and 2) the prospective collection of medical record data related to treatment of thyroid cancer.
详细描述
The aim of the proposed pilot study is to use a clinical algorithm that incorporates molecular, clinical and radiographic factors to inform surgical management. This study is the first to propose molecular-directed surgical management for this commonly diagnosed cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Thyroid nodule is >1.5 cm
- •Preoperative FNA biopsy that is positive for papillary thyroid cancer or suspicious for papillary thyroid cancer
排除标准
- •Prior thyroid/parathyroid surgery
- •Clinical indications for total thyroidectomy including hypothyroidism, history of head or neck radiation when <18 years old
- •Recurrent laryngeal nerve dysfunction
- •Diagnosis of concurrent primary hyperparathyroidism
结局指标
主要结局
Number of patients who require completion thyroidectomy for aggressive histology features
时间窗: 2 years
Histology characteristics of tumor will be assessed including type of cancer, extrathyroidal extension, lymph node metastasis, and margin status to assess if completion thyroidectomy is needed per the 2015 ATA guidelines
次要结局
- QOL metric - QOL-Thyroid cumulative score preop, postop, and at followup(2 years)
- Number of patients who had central compartment neck dissection but no lymph node metastasis were identified(2 years)
- Number of patients with operative complications(2 years)
- QOL metric - FACT-G cumulative score preop, postop, and at followup(2 years)
- Recurrence(>2 years)
- QOL metric - SF36 cumulative score preop, postop, and at followup(2 years)
研究者
Linwah Yip
MD
University of Pittsburgh