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Completed

NCT Number: NCT03109457

Hepatitis C Virus Detection in Oral Squamous Cell Carcinoma

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

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Key information

About this study

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:-

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

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Exclusion criteria

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

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Treatment and study plan

oral squamous cell carcinoma

Other

Histological diagnosis of H&E stained sections will be performed according to WHO guidelines by 2 independent pathologists.

Other names: OSCC

Primary outcomes

  1. Hep C cAg by Immunohistochemistry

    Time frame: 5 years

    Hepatitis C core antigen by immunohistochemical analysis

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 12, 2017
Registry last updated
Feb 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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