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临床试验/NCT03554967
NCT03554967已完成不适用

Toluidine Blue Versus Frozen Sections for Assessment of Tumor Margins in Oral Squamous Cell Carcinoma

Cairo University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年7月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Diagnostic accuracy of toluidine blue VS frozen section for tumor margin assessment.

研究概览

简要总结

The purpose of this study is to test the accuracy of toluidine blue in the assessment of intraoperative tumor margin after excision of oral squamous cell carcinoma(OSCC)in comparison to H&E stain on frozen section.

详细描述

The incidence of oral cancer remains high, it is ranked to be the sixth most common cancer worldwide, oral squamous cell carcinoma represent more than 90% of all oral malignances.

Standard treatment for oral squamous cell carcinoma is surgical resection with free margin. Negative margin status is an important for control local recurrence and improve outcome in squamous cell carcinoma of the head and neck. Hematoxylin and Eosin (H&E) Frozen section biopsy is useful tool for intraoperative assessment of resected margins and control of local recurrence, allowing for additional resection intraoperatively in case of positive margins. However in the least developed countries with limited resource, the frozen section is not available in a majority of centers, in addition to that if present in developed countries, it somewhat considered time and cost consumer.

Toluidine blue(TB) is metachromatic stain, easily available, economical, with high affinity for DNA and RNA. It is rapidly uptaken by malignant epithelium which contain quantitatively more nucleic acid than normal tissue. It has been widely used as screening tool for malignant and premalignant lesion.

The purpose of this study is to test the accuracy of toluidine blue in the assessment of intraoperative tumor margin after excision of oral squamous cell carcinoma(OSCC)in comparison to H&E stain on frozen section.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Other

入排标准

性别
All
接受健康志愿者

入选标准

  • Patient with biopsy-proven primary oral squamous cell carcinoma undergoing primary excision.

排除标准

  • Patients with prior history of head and neck malignancy
  • Patients with non-squamous cell carcinoma.
  • Patients with previously undergone treatment (surgery and/or radio-/ chemotherapy) for the current oral squamous cell carcinoma.

结局指标

主要结局

Diagnostic accuracy of toluidine blue VS frozen section for tumor margin assessment.

时间窗: tumor margin will be assessed intraoperatively

The diagnostic accuracy will be assessed by comparing the results of each technique with the final routine histopathological results.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hana'a Hezam Ghaleb Algadi

principal investigator

Cairo University

研究点 (1)

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