NCT01198119终止2 期
Excision Limits of Oral Cavity Tumor by NARROW BAND IMAGING (NBI): Feasibility Trial
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Reliability for detection of subclinical lesions
研究概览
简要总结
This study evaluates the feasibility of the NBI technique in the detection of early cancer lesions.
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
- •Primitive epidermoid cancer of the oral cavity, proved by histology, not treated previously, patient having a surgery
- •No previous surgery for this cancer
- •Age > 18 years
- •Patient affiliated to health insurance
- •Consent signed by the patient
排除标准
- •Metastatic or recurrent disease
- •Health care impossibilities for geographic, social, psychic reasons
研究组 & 干预措施
Patient with oral cavity cancer
Experimental
Patient treated by surgery for the oral cavity cancer
干预措施: Location of the suspected lesions (Device)
Patient with oral cavity cancer
Experimental
Patient treated by surgery for the oral cavity cancer
干预措施: Biopsy (Procedure)
Patient with oral cavity cancer
Experimental
Patient treated by surgery for the oral cavity cancer
干预措施: Lesion excision/Surgery (Procedure)
结局指标
主要结局
Reliability for detection of subclinical lesions
时间窗: baseline
Concordance between the histological data and the lesions detected by the NBI technique
次要结局
- Excision limits quality criteria(baseline)
- Detection of suspect lesions(baseline)
研究者
研究点 (1)
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