NCT02656576已完成不适用
Detection of Human Papillomavirus in Polymerase Chain for Suspicious Lesions of the Amygdala: Concordance Smear-Biopsy
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- the correlation between the two sampling methods
研究概览
简要总结
Multicentre prospective study of concordance between two tissue sampling modes (smear / biopsy), which applies the same diagnostic method (PCR).
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
- •Presents a suspicious lesion of the amygdala region
- •Have a biopsy of the oropharynx planned in the operating room.
排除标准
- •Pregnant Patient.
- •Against anesthetic or surgical indication for endoscopy of the upper aerodigestive tract.
研究组 & 干预措施
patient with suspected lesions of the tonsillar region
Other
patients will have a tonsil biopsy and a smear
干预措施: Tonsil Biopsy (Procedure)
patient with suspected lesions of the tonsillar region
Other
patients will have a tonsil biopsy and a smear
干预措施: Smear (Procedure)
结局指标
主要结局
the correlation between the two sampling methods
时间窗: 1 month
the correlation between the two sampling methods (smear and biopsy), defined by the probability of positive correlation and the negative concordance probability.
次要结局
- the overall agreement(1 month)
- rate of concordance for the detection of HPV between biopsy and smear(1 month)
研究者
研究点 (2)
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