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临床试验/NCT03109457
NCT03109457已完成不适用

Hepatitis C Virus Detection in Oral Squamous Cell Carcinoma. (Retrospective-cohort Study)

Cairo University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2017年9月6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
40
试验地点
1
主要终点
Hep C cAg by Immunohistochemistry

研究概览

简要总结

Compare Hepatiis C Virus (HCV) detection between oral squamous cell carcinoma (OSCC) and normal tissues, to determine the possible relationship between HCV and OSCC.

详细描述

Patient / Population: Paraffin embedded tissue samples of OSCC. Indicator: OSCC patients Control: Normal patients Formalin fixed paraffin embedded specimens from blocks retrieved from the archives of the Oral and Maxillofacial Pathology Department, Faculty of dentistry, Kasr Alini hospital setting from January 2014 till February 2018. All clinical and histopathological data from medical reports, will be reviewed and data will be collected regarding age, sex, tumor location, history of smoking and alcohol consumption, nodal status, tumor recurrences and histological classification of the patients. The specimens will be obtained from 2 groups:-

  1. OSCC specimens. Histological diagnosis of H&E stained sections will be performed according to World health organisation (WHO) guidelines by 2 independent pathologists.
  2. Normal oral mucosa specimens (control).

outcome: I) Immunohistochemical detection of Hepatitis C core antigen (Hep C cAg) : sc-58144, santa cruz biotechnology, USA) a mouse monoclonal antibody raised against Hepatitis C virus will be purchased and used for immunohistochemical staining. Staining procedure using an automated system Ventana Benchmark. The four µm thick paraffin embedded tissue sections will be deparaffinized in three changes of xylene then microwaved for antigen retrieval. The slides will be incubated with primary antibody overnight in the humidity chamber at room temperature. Then, the slides will be incubated with secondary antibody. The peroxidase activity will be made visible with diaminobenzidine. Finally, counterstaining will be obtained using Mayer's hematoxylin.

The immunostained sections will be examined using analyzer computer system (Germany).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Presence of sufficient paraffin-embedded tumor material;
  • Presence of oral cavity cancer (including oral tongue, floor of mouth, gingiva, lips, buccal mucosa)
  • Absence of recurrent head and neck cancer
  • Absence of previous oncologic therapy;
  • Histological-proven squamous cell carcinoma.

排除标准

  • subjects with missing information on age or sex will be excluded.

结局指标

主要结局

Hep C cAg by Immunohistochemistry

时间窗: 5 years

Hepatitis C core antigen by immunohistochemical analysis

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

Noura Kamal Aly

assistant lecturer, Oral and Maxillofacial pathology

Cairo University

研究点 (1)

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