Hepatitis C Virus Detection in Oral Squamous Cell Carcinoma
1 other identifier
observational
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Sep 2017
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 3, 2017
CompletedFirst Posted
Study publicly available on registry
April 12, 2017
CompletedStudy Start
First participant enrolled
September 6, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 7, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 15, 2018
CompletedFebruary 5, 2020
February 1, 2020
5 months
April 3, 2017
February 1, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hep C cAg by Immunohistochemistry
Hepatitis C core antigen by immunohistochemical analysis
5 years
Study Arms (2)
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.
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.
Interventions
Histological diagnosis of H\&E stained sections will be performed according to WHO guidelines by 2 independent pathologists.
Eligibility Criteria
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
You may qualify if:
- 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.
You may not qualify if:
- subjects with missing information on age or sex will be excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Kasr ALini Hospital
Giza, Cairo Governorate, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nora Ali, Msc
Assistant Lecturer at Oral and Maxillofacial pathology
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- assistant lecturer, Oral and Maxillofacial pathology
Study Record Dates
First Submitted
April 3, 2017
First Posted
April 12, 2017
Study Start
September 6, 2017
Primary Completion
February 7, 2018
Study Completion
September 15, 2018
Last Updated
February 5, 2020
Record last verified: 2020-02