NCT02852343已完成不适用
Etude de Concordance Entre la Technique OSNA et Les Techniques Classiques Pour la Recherche de métastases Ganglionnaires Des Cancers Des VADS
Rennes University Hospital1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2015年1月5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
- 26
- 试验地点
- 1
- 主要终点
- number of CK19 mRNA copies/µL of diluted lymph node lysate
研究概览
简要总结
The investigators main objective is to show that OSNA technique is as accurate as pathological analysis (frozen section / HE staining and immunochemistry) to detect occult lymph node metastasis (micro and macrometastasis).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patient > 18 years old
- •Head and neck squamous cell carcinoma diagnosed by biopsy
- •N0 classification (N0: no lymph node invasion on clinical and radiological examination).
- •Neck dissection or sentinel lymph node biopsy required to treat the patient
- •ECOG 1,2 or 3
- •Patient's consent
排除标准
- •Patient previously treated by radiotherapy or surgery for head and neck neoplasm.
- •Contraindication or patient unwillingness to undergo surgical treatment
- •Incapacitated adults
结局指标
主要结局
number of CK19 mRNA copies/µL of diluted lymph node lysate
时间窗: through study completion, an average of 1 year
次要结局
未报告次要终点
研究者
研究点 (1)
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