Interest of Cytological Screening for Early Diagnosis of Precancerous or Cancerous Lesions of Oral Cavity by Transepithelial Brushing in Liquid-based
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Diagnostic validity of lesion (Bethesda system, 2001)
研究概览
简要总结
Prospective study of diagnosis validation of a cytological technique. 200 patients with oral cavity cancerous and precancerous lesions will be enrolled.
A cytological sample of the lesion will be performed by transepithelial brushing ( Orcellex® Rovers brush) in cytology liquid-based technology (methode ThinPrep 2000 (Hologic®)). A microscopic double blind reading will be performed. A biopsy sampling will be carried out in accordance with current strategy of screening. The brushing diagnosis quality will be compared to the biopsy which is the gold standard.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •one or several cancerous or pre-cancerous lesions of oral cavity newly diagnosed or detected during a follow-up visit
排除标准
- •pregnant or lactating women
- •patients under juridical protection
结局指标
主要结局
Diagnostic validity of lesion (Bethesda system, 2001)
时间窗: baseline
Diagnostic validity (specificity and sensibility, the classification of lesions is performed according Bethesda system, 2001 and the reference is the histology of biopsy of lesion
次要结局
- Reproducibility intra and inter observers (coefficient of kappa de cohen)(Baseline)
- Diagnostic validity - predictive value (positive and negative)(baseline)
- Feasibility of cytology(Baseline)