NCT01880203已完成不适用
Diagnostic Value of Molecular Cytological Analysis (CMA) and Shear Wave Elastography ShearWave (SWE) in Patients With a Thyroid Nodule With Indeterminate Cytology: Feasibility Study
Centre Francois Baclesse7 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2013年5月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 7
- 主要终点
- Evaluate the diagnostic performance of the AMC and SWE elastography
研究概览
简要总结
The purpose of the study is to investigate the contribution of molecular cytological analysis (CMA) and shear wave elastography ShearWave (SWE) in the diagnosis of nodules with indeterminate cytology (IC)
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
- •Age ≥ 18 years
- •Patients with thyroid nodules ≥ 15 mm with an indeterminate cytology (IC) older than 6 months, for which a surgical indication was raised
- •vesicular lesion of undetermined significance
- •follicular neoplasm or Hurthle cells
- •lesion suspicious for malignancy
- •Confirmation of indeterminate cytology (IC) replay centralized
- •Patient affiliated to a social security scheme
- •Informed consent and signed
排除标准
- •Thyroid node <15 mm
- •Nodules coalescing preventing proper individualization of targeted nodule
- •Indeterminate cytology older than six months
- •Nodules with indeterminate cytology not, ie non-diagnostic cytology, benign and malignant cytology cytology
- •Major subject to a measure of legal protection or unable to consent
- •Refusal to participate
结局指标
主要结局
Evaluate the diagnostic performance of the AMC and SWE elastography
时间窗: at inclusion, before surgery
Evaluate the diagnostic performance of the AMC and SWE elastography in patients with a thyroid nodule CI taking as reference the histology of the nodule.
次要结局
- evaluate the diagnostic performance of elastography SWE(at inclusion, before surgery)
- Establish a combined diagnostic score results of elastography(at inclusion, before surgery)
研究者
研究点 (7)
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