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临床试验/NCT03837613
NCT03837613Unknown不适用

Prognostic Value of Tumor Thickness of Buccal Mucosa Squamous Cell Carcinoma on the Incidence of Nodal Metastasis in the Neck: A Cohort Study

Mohamed Ghorab1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年2月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
20
试验地点
1
主要终点
Cervical nodal metastasis

研究概览

简要总结

Does the tumor thickness value of buccal squamous cell carcinomas, predict cervical nodal metastasis in clinically and radio-graphical neck negative (N0) thus sparing such patients unnecessary surgical procedures and it's associated morbidities? The aim of the study is to evaluate the prognostic value of tumor thickness cut off 4 mm in predicting cervical nodal metastases in a population of Egyptian patients presenting with Buccal Squamous Cell Carcinoma. The hypothesis is that patients with tumor thickness less than 4 mm will present with significantly less cervical nodal metastasis.

详细描述

Patients will be recruited from the outpatient clinics of Al Monofia university hospital, Cairo University Hospital and National Cancer Institute. Patients who fits the inclusion criteria and are motivated and consent to enter the study will be included. Patient recruitment will continue until the target sample size is reached.

Patients data will be collected including personal data, medical history, family history, and classification of the tumor according to the TNM classification system. Patients will be assessed preoperatively with a transcutaneous high frequency probe ultrasound to measure the maximal tumor thickness in millimeters using a 10MHz superficial probe and the lymph nodes in the neck region. In addition to clinical examination and palpation of the neck lymph nodes. Patients will then undergo tumor resection surgery with adequate safety margins under GA with nasotracheal intubation. Selective neck dissection will then be performed. The specimens will be submitted for histopathological examination.

Patients will receive standard post operative care based on the recommendation of the oncologist. Adjunct chemo or radiotherapy will be administered when deemed necessary. Wound care and dressings will be administered as needed.

Patients will be categorized into two groups based on the tumor thickness (exposure).

For the primary outcome, the data source will be the measurement of tumor depth based on Berslow method as discussed in the review of literature, obtained from ultrasonography and recorded in millimeters.Tumor width recorded in (mm) will also be obtained from the ultrasonography as it may be a source of confounders. Further, histological grade of the lesion will also be recorded.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Egyptian patients with BSCC (T all N0) not previously operated or treated with adjunctive therapy. They should present with no clinical signs of neck lymph nodes involvement.

排除标准

  • Patients with lesions secondary to another primary site.
  • Patients previously removed a primary oral surgery tumor in another site
  • Patients with clinical or radiographic evidence of cervical nodal metastases

结局指标

主要结局

Cervical nodal metastasis

时间窗: one week after the surgery

Number of patients with positive cervical nodal metastasis

次要结局

  • Tumor thickness(one week after the surgery)

研究者

发起方
Mohamed Ghorab
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Mohamed Ghorab

Principal Investigator

Cairo University

研究点 (1)

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