Hepatitis C Virus Detection in Oral Squamous Cell Carcinoma

NCT ID: NCT03109457

Last Updated: 2020-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-09-06

Study Completion Date

2018-09-15

Brief Summary

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

Detailed Description

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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).

Conditions

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Hepatitis C

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

oral squamous cell carcinoma

Intervention Type OTHER

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

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.

oral squamous cell carcinoma

Intervention Type OTHER

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

Interventions

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oral squamous cell carcinoma

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

Intervention Type OTHER

Other Intervention Names

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OSCC

Eligibility Criteria

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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.

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Exclusion Criteria

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

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Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Noura Kamal Aly

assistant lecturer, Oral and Maxillofacial pathology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nora Ali, Msc

Role: PRINCIPAL_INVESTIGATOR

Assistant Lecturer at Oral and Maxillofacial pathology

Locations

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Kasr ALini Hospital

Giza, Cairo Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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CEBD-CU-2017-04-01

Identifier Type: -

Identifier Source: org_study_id

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