Hepatitis CNCT03109457
Hepatitis C Virus Detection in Oral Squamous Cell Carcinoma
An observational study of Hepatitis C, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hepatitis C
- What is being tested?
- oral squamous cell carcinoma
- Type of treatment
- Pill or oral medicine
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 6 Sep 2017to 15 Sep 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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.
- -
Who cannot join
- subjects with missing information on age or sex will be excluded.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hepatitis C Virus Detection in Oral Squamous Cell Carcinoma. (Retrospective-cohort Study)
Compare Hepatiis C Virus (HCV) detection between oral squamous cell carcinoma (OSCC) and normal tissues, to determine the possible relationship between HCV and OSCC.
Read the 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:-
- 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).
- Conditions
- Hepatitis C
- Being tested
- oral squamous cell carcinoma
- Keywords
- Hepatitis C Virus, Oral squamous cell carcinoma
- Medical subject headings
- Hepatitis C, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral squamous cell carcinomaOther
Also called OSCC
Histological diagnosis of H\&E stained sections will be performed according to WHO guidelines by 2 independent pathologists.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: oral squamous cell carcinoma | |
| 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. Receives: Other: oral squamous cell carcinoma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hep C cAg by Immunohistochemistry
Hepatitis C core antigen by immunohistochemical analysis
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2017
- Study start6 Sep 2017
- Primary completion7 Feb 2018
- Study completion15 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noura Kamal Aly, Cairo University
- Investigators
- Nora Ali, Msc, Principal investigator, Assistant Lecturer at Oral and Maxillofacial pathology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03109457
- Sponsor's protocol ID
- CEBD-CU-2017-04-01
- Status last verified
- Feb 2020
- First submitted
- 3 Apr 2017
- Last updated
- 5 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hepatitis C Virus Detection in Oral Squamous Cell Carcinoma. (Retrospective-cohort Study)
- ClinicalTrials.gov ID
- NCT03109457
- Acronym / sponsor ID
- CEBD-CU-2017-04-01
- Conditions
- Hepatitis C
- Keywords
- Hepatitis C Virus, Oral squamous cell carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 6 Sep 2017 (actual)
- Primary completion
- 7 Feb 2018 (actual)
- Study completion
- 15 Sep 2018 (actual)
- First posted
- 12 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral squamous cell carcinoma | – | Other: oral squamous cell carcinomaSections (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 | – | Other: oral squamous cell carcinomaSections (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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (2 listed)
- subjects with missing information on age or sex will be excluded.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oral squamous cell carcinomaAlso: OSCCHistological diagnosis of H\&E stained sections will be performed according to WHO guidelines by 2 independent pathologists. | Other | Control, Oral squamous cell carcinoma |
Primary outcome
Hep C cAg by Immunohistochemistry
Time frame: 5 years
Hepatitis C core antigen by immunohistochemical analysis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
Related trials for Hepatitis C
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Not yet recruiting
Clinical Study to Evaluate the Performance of the INSTI® HCV Antibody Test for CLIA-Waived Use
HCV Infection
Not yet recruiting
Study to Evaluate the Performance of the INSTI® HCV Antibody Test for Point-of-Care Use in Individuals at Risk for HCV Infection or Presenting With Signs or Symptoms of HCV Infection
HCV Infection
RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
Chronic Liver Disease and Cirrhosis, Liver Cancer
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nora Ali, Msc principal investigator
Assistant Lecturer at Oral and Maxillofacial pathology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis C, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hep C cAg by Immunohistochemistry (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2020.