NCT07127614尚未招募不适用
The Relationship Between Primary Tumor Depth of Invasion and Neck Lymph Nodes Management in T1T2N0 Oral Cavity Squamous Cell Carcinomas
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Diagnostic accuracy
研究概览
简要总结
To evaluate the diagnostic accuracy of preoperative MRI in the determination of the primary tumor depth of invasion (DOI) as a predictor factor in neck lymph nodes management in T1T2N0 oral cavity squamous cell carcinomas as compared to the pathological depth of invasion
详细描述
A diagnostic accuracy study comparing preoperative MRI scans to pathological examination of the resected oral squamous cell carcinoma with lymph nodes to determine the depth of invasion.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with biopsy-proven oral squamous cell carcinoma with the edition T1or T2 N0 based on TNM staging by the American Joint Cancer Center AJCC 8th edition
- •The primary tumor has a depth of invasion (DOI) greater than 4 mm
- •Clinical N0 status confirmed by reasonable parameters includes computed tomography CT, MRI, -Ultrasonography,( US fine needle aspiration in suspected lymph nodes )
- •The primary tumor must be reliably resected to a clear margin without the need for entry of the neck for reconstruction
排除标准
- •Patients with T3T4 OCSCC
- •Proven or suspected positive neck node
- •Patient with distant metastasis
- •Patient with gross injury to the neck that precludes proper surgical dissection.
- •Patient with a history of radiotherapy to the neck
- •Recurrent cases of OCSCC or recurrent node disease
- •Patient with previous neck node biopsy or previous neck dissection
- •Patient with a medical condition or performance that interferes with the surgical intervention as judged by the specialist physician
结局指标
主要结局
Diagnostic accuracy
时间窗: immediately after the surgery
determination of the diagnostic accuracy of MRI in determining the depth of invasion compared to the pathological depth of invasion
次要结局
未报告次要终点
研究者
Islam Mohamed Mohamed Ali
Assistant Lecturer
Al-Azhar University
研究点 (1)
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