Immunohistochemical Detection of the BRAFV600E Mutation on Cytological Specimen in PTC
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 2
- 主要终点
- Immunohistochemical detection of BRAF mutation on fine needle aspiration biopsy (FNAB)
研究概览
简要总结
Immunohistochemical detection of the BRAF-V600E mutation on pre-operative fine needle aspiration biopsy (FNAB) from patients suspected for papillary thyroid carcinoma, using the mutation specific antibody VE1.
详细描述
The BRAF mutation is reported to be present in approximately 50% of papillary thyroid carcinomas (PTC). The mutation has been associated with poor prognosis and more advanced disease stage. Therefore, pre-operative detection of the BRAF-V600E mutation may be of clinical interest in order to individualize treatment of patients with BRAF positive PTC.
FNABs are performed immediately before the thyroid operation, and BRAF-V600E detection using VE1 is performed on clots. The VE1 stain is compared to the mutation status of the removed cancer or control tissue using the Cobas test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Bethesda system of reporting thyroid cytology (BSRTC) group 5-6 on pre-operative FNAB from the nodule (>1cm)
- •Undergoing thyroid surgery (histology of index nodule)
排除标准
- •Not undergoing thyroid surgery
研究组 & 干预措施
BRAF immunohistochemistry (IHC)
干预措施: BRAF detection on fine needle aspiration biopsy (FNAB) (Other)
结局指标
主要结局
Immunohistochemical detection of BRAF mutation on fine needle aspiration biopsy (FNAB)
时间窗: 1 day
Mutations status correlated to histological diagnoses and mutation status on histological samples
次要结局
未报告次要终点
研究者
Kristine Zøylner Rubeck
MD PhD-student
University of Aarhus