临床试验/NCT01626638

NCT01626638已完成不适用

Clinical Evaluation of Confocal Microscopy in Head and Neck Cancer

Gustave Roussy, Cancer Campus, Grand Paris3 个研究点分布在 1 个国家目标入组 44 人开始时间: 2013年2月1日最近更新: 2021年2月18日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: Gustave Roussy, Cancer Campus, Grand Paris
入组人数: 44
试验地点: 3
主要终点: Diagnostic correlation between confocal micro endoscopy and conventional histology

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The primary objective is to validate the diagnostic correlation between the intraoperative microendoscopic images and the conventional histological analysis on biopsy and/or surgical specimens on patients with epidermoid carcinoma.

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

•Patients with malignant and pre-malignant pharyngo laryngeal tumors in whom direct laryngoscopy was performed under general anesthesia with biopsies for diagnostic or endoscopic removal
•> 18 years
•signed ICF

排除标准

•Persons deprived of liberty
•Patients with history of allergy to patent blue
•Pregnant women or breastfeeding women

结局指标

主要结局

Diagnostic correlation between confocal micro endoscopy and conventional histology

时间窗: at an average of 18 months

次要结局

Histological diagnostic with confocal micro endoscopy (MEC) VS conventional histological analysis(At the time of the biopsy)

研究者

发起方

Gustave Roussy, Cancer Campus, Grand Paris

申办方类型

Other

责任方

Sponsor

研究点 (3)

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