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Hepatitis C Virus Detection in Oral Squamous Cell Carcinoma

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ClinicalTrials.gov Identifier: NCT03109457
Recruitment Status : Not yet recruiting
First Posted : April 12, 2017
Last Update Posted : April 13, 2017
Sponsor:
Information provided by (Responsible Party):
Noura Kamal Aly, Cairo University

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

Condition or disease Intervention/treatment
Hepatitis C Other: oral squamous cell carcinoma

Detailed Description:

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).


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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Hepatitis C Virus Detection in Oral Squamous Cell Carcinoma. (Retrospective-cohort Study)
Estimated Study Start Date : September 2017
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Oral squamous cell carcinoma

Sections (4-5 microns thick) will be cut for the immunohistochemical procedure, from each paraffin block and placed on positively charged (Opti-plus) slides by the technicians in the Oral and Maxillofacial laboratory setting.

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.

Other: oral squamous cell carcinoma
Histological diagnosis of H&E stained sections will be performed according to WHO guidelines by 2 independent pathologists.
Other Name: OSCC

Control

Sections (4-5 microns thick) will be cut for the immunohistochemical procedure, from each paraffin block and placed on positively charged (Opti-plus) slides by the technicians in the Oral and Maxillofacial laboratory setting.

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.

Other: oral squamous cell carcinoma
Histological diagnosis of H&E stained sections will be performed according to WHO guidelines by 2 independent pathologists.
Other Name: OSCC




Primary Outcome Measures :
  1. Hep C cAg by Immunohistochemistry [ Time Frame: 5 years ]
    Hepatitis C core antigen by immunohistochemical analysis



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
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
Criteria

Inclusion Criteria:

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

    Exclusion Criteria:

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


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Responsible Party: Noura Kamal Aly, assistant lecturer, Oral and Maxillofacial pathology, Cairo University
ClinicalTrials.gov Identifier: NCT03109457     History of Changes
Other Study ID Numbers: CEBD-CU-2017-04-01
First Posted: April 12, 2017    Key Record Dates
Last Update Posted: April 13, 2017
Last Verified: April 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Noura Kamal Aly, Cairo University:
Hepatitis C Virus
Oral squamous cell carcinoma

Additional relevant MeSH terms:
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Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Viral, Human
Carcinoma
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Neoplasms, Squamous Cell
Flaviviridae Infections