Human Papilloma Virus (HPV) Prevalence in the Mouth and Oropharynx of the General Population (Oromouth)
This study is not yet open for participant recruitment.
Verified March 2011 by University Hospitals Coventry and Warwickshire NHS Trust
Sponsor:
University Hospitals Coventry and Warwickshire NHS Trust
Collaborator:
GlaxoSmithKline
Information provided by:
University Hospitals Coventry and Warwickshire NHS Trust
ClinicalTrials.gov Identifier:
NCT01330147
First received: April 1, 2011
Last updated: April 5, 2011
Last verified: March 2011
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Purpose
The principal aim of this study is to provide vital current data on the prevalence, distribution and natural history of Human Papilloma Virus (HPV) infection in the mouth. This data is an essential requirement for the assessment, development and evaluation of costeffectiveness of prophylactic vaccination and screening programmes.
| Condition |
|---|
|
Chronic Tonsillitis |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | HPV Prevalence in the Mouth and Oropharynx of the General Population |
Resource links provided by NLM:
Further study details as provided by University Hospitals Coventry and Warwickshire NHS Trust:
Primary Outcome Measures:
- Occurrence of HPV in tonsils and in oral scrape sample [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- HPV vaccination status [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Saliva, Urine, Whole Blood, Mouth brush biopsies (scrapes) and tonsillectomy specimens
| Estimated Enrollment: | 1250 |
| Study Start Date: | August 2011 |
| Estimated Study Completion Date: | July 2015 |
| Estimated Primary Completion Date: | July 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Tonsillectomy
Subjects undergoing tonsillectomy for non-cancer reasons including operations for: recurrent tonsillitis, asymmetric tonsils, snoring surgery or obstructive sleep apnoea.
|
Detailed Description:
Patients undergoing a tonsillectomy operation for non-cancerous reasons will be recruited for this study. They will be asked to complete two questionnaires (study and sexual practices), provide saliva, urine and a blood sample. Following anaesthesia, oral mucosal scrappings and a tonsillectomy will be performed and all the samples will be processed for evidence of HPV infection.
Eligibility| Ages Eligible for Study: | 1 Year to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients undergoing a tonsillectomy operation for non-cancerous reasons at the hospital will be recruited for this study.
Criteria
Inclusion Criteria:
- Subjects undergoing tonsillectomy for non cancer reasons including operations for: recurrent tonsillitis, asymmetric tonsils, snoring surgery or obstructive sleep apnoea
- Age - 0 to 55 years
- Subject or legal guardian has given informed written consent
Exclusion Criteria:
- Subjects undergoing adenoidectomy alone with no tonsillectomy
- Subjects with previous oropharyngeal cancer or oral cancer, or any other head and neck cancer such as nasopharyngeal or laryngeal cancer that is currently undergoing or has previously been diagnosed or treated
- Learning disability preventing an adult over 16 years old from giving their own consent
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01330147
Contacts
| Contact: Hisham Mehanna, PhD | +44 - 2476965244 | hishammehanna@aol.com |
| Contact: Rehan Kazi, PhD | +44 - 2476965249 | rehan.kazi@uhcw.nhs.uk |
Locations
| United Kingdom | |
| University Hospitals Coventry | Not yet recruiting |
| Coventry, England, United Kingdom, CV2 2DX | |
| Principal Investigator: Hisham Mehanna, PhD | |
| Sub-Investigator: Rehan Kazi, PhD | |
Sponsors and Collaborators
University Hospitals Coventry and Warwickshire NHS Trust
GlaxoSmithKline
Investigators
| Principal Investigator: | Hisham Mehanna, FRCS, PhD | University Hospitals Coventry and Warwickshire NHS Trust |
More Information
No publications provided
| Responsible Party: | Ms. Sylvia Taylor, GSK Biologicals |
| ClinicalTrials.gov Identifier: | NCT01330147 History of Changes |
| Other Study ID Numbers: | HM086011 |
| Study First Received: | April 1, 2011 |
| Last Updated: | April 5, 2011 |
| Health Authority: | United Kingdom: National Health Service |
Keywords provided by University Hospitals Coventry and Warwickshire NHS Trust:
|
HPV oral cancer oropharyngeal cancer tonsillectomy |
Additional relevant MeSH terms:
|
Tonsillitis Chronic Disease Pharyngitis Pharyngeal Diseases Stomatognathic Diseases |
Respiratory Tract Infections Respiratory Tract Diseases Otorhinolaryngologic Diseases Disease Attributes Pathologic Processes |
ClinicalTrials.gov processed this record on May 19, 2013