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临床试验/NCT06169605
NCT06169605招募中不适用

Assessment of the Effect of Tumor Thickness and Site on Level IV Cervical Lymph Nodes in Squamous Cell Carcinoma of the Tongue and Floor of the Mouth: A Case Series Study

Cairo University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
20
试验地点
1
主要终点
Number of affected level IV cervical lymph nodes

研究概览

简要总结

Regarding oral cavity cancer, the high incidence of neck metastasis along with its impact on survival and prognosis are in favor of elective neck dissection. Moreover, occult metastases could develop at lower levels in the neck (levels IV-V) Regarding the tongue, the rate of skip (occult) metastasis involving unremoved level IV cervical lymph nodes in squamous cell carcinoma of the tongue ranges from 0 % - 11.4 %. However, no data is available or a correlation between the risk of level IV involvement and the affection of specific tongue subsites or a certain cutoff value of tumor thickness.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
15 Years 至 60 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with squamous cell carcinoma of the tongue and floor of the mouth.
  • Age group: from 15 to 60 years old
  • No sex predilection

排除标准

  • Patients with recurrent squamous cell carcinoma of the tongue and floor of the mouth.
  • Irradiated patients or those taking chemotherapy.

结局指标

主要结局

Number of affected level IV cervical lymph nodes

时间窗: One week : submitted immediately after surgery

In each case the specimen will be assessed for level IV lymph nodes affection

tumor thickness in mellimeters

时间窗: one week: specimens are submitted immediately after surgery

histological assessment of tumor thickness of the resected tumor and assessment of level IV lymph nodes

次要结局

  • affected tongue site in relation to level IV cervical lymph nodes(One week)

研究者

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

Mohamed Shawky

Assistant lecturer

Cairo University

研究点 (1)

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