NCT00534612Unknown早期 1 期
Accuracy of Fine Needle Aspiration Biopsy in the Pre-Operative Diagnosis of Malignancy in Patients With Parotid Gland Masses
National Institute of Cancerología2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2003年1月1日最近更新:
适应症
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Diagnosis of malignancy
研究概览
简要总结
Liberal use of fine needle aspiration biopsy of parotid gland masses is controversial. All information regarding this procedure has been retrospective. Our objective is to evaluate prospectively the diagnostic accuracy of the test, alone and when associated to clinical and/or radiologic data.
详细描述
This is a prospective diagnostic test study. Inclusion criteria are all consecutive patients with parotid gland masses referred for treatment at our center, from January 2003 to December 2007.
The gold standard for the diagnosis of malignancy is the surgical pathology report of the parotidectomy specimen.
Cytologist and pathologist will be blind. Diagnostic accuracy is determinded by Bayesian analysis.
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
- Double (Investigator, Outcomes Assessor)
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
- •Consecutive patients with parotid gland masses
排除标准
- 未提供
结局指标
主要结局
Diagnosis of malignancy
时间窗: three years
次要结局
- Specific histopathologic diagnosis(three years)
研究者
研究点 (2)
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