HPV Prevalence in the Mouth and Oropharynx of the Tonsillectomy Population (Oromouth)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01330147 |
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Recruitment Status
:
Completed
First Posted
: April 6, 2011
Last Update Posted
: May 18, 2017
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Sponsor:
University of Birmingham
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
University of Birmingham
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Brief Summary:
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 cost effectiveness of prophylactic vaccination and screening programmes.
| Condition or disease |
|---|
| Chronic Tonsillitis |
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, oropharyngeal brushings and a tonsillectomy will be performed and all the samples will be processed for evidence of HPV infection.
| Study Type : | Observational |
| Actual Enrollment : | 937 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | HPV Prevalence in the Mouth and Oropharynx of the Tonsillectomy Population |
| Study Start Date : | March 2013 |
| Actual Primary Completion Date : | September 28, 2015 |
| Actual Study Completion Date : | September 28, 2015 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Tonsillitis
U.S. FDA Resources
| Group/Cohort |
|---|
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Tonsillectomy
Subjects undergoing tonsillectomy for non-cancer reasons including operations for: recurrent tonsillitis, asymmetric tonsils, snoring surgery or obstructive sleep apnoea.
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Primary Outcome Measures
:
- Occurrence of HPV in tonsils and in oral scrape sample [ Time Frame: 36 months ]Presence of HPV result
Secondary Outcome Measures
:
- HPV vaccination status [ Time Frame: 36 months ]vaccination received yes/no and the type of vaccination description
Biospecimen Retention: Samples With DNA
Oral rinse, Oral Mucosal Trasudate, Urine, Whole Blood, Nail brushings, Mouth brush biopsies (scrapes) and Tonsillectomy specimens
Information from the National Library of Medicine
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| Ages Eligible for Study: | up to 65 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| 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 65 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01330147
Locations
| United Kingdom | |
| University Hospitals Coventry & Warwickshire Trust | |
| Coventry, England, United Kingdom, CV2 2DX | |
| University Hospital Birmingham | |
| Birmingham, West Midlands, United Kingdom, B15 2GW | |
| Birmingham City Hospital | |
| Birmingham, United Kingdom, B18 7QH | |
| Birmingham Children Hospital | |
| Birmingham, United Kingdom, B4 6NH | |
| Heartlands Hospital | |
| Birmingham, United Kingdom, B9 5SS | |
| Kidderminster Hospital | |
| Kidderminster, United Kingdom, DY11 6RJ | |
| New Cross Hospital | |
| Wolverhampton, United Kingdom, WV10 0QP | |
| Worcestershire Royal Hospital | |
| Worcester, United Kingdom, WR5 1DD | |
Sponsors and Collaborators
University of Birmingham
GlaxoSmithKline
Investigators
| Principal Investigator: | Hisham Mehanna, Prof | The University of Birmingham |
| Responsible Party: | University of Birmingham |
| ClinicalTrials.gov Identifier: | NCT01330147 History of Changes |
| Other Study ID Numbers: |
RG12-208 12344 ( Other Identifier: NIHR ) |
| First Posted: | April 6, 2011 Key Record Dates |
| Last Update Posted: | May 18, 2017 |
| Last Verified: | May 2017 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
Keywords provided by University of Birmingham:
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HPV oral cancer oropharyngeal cancer tonsillectomy |
Additional relevant MeSH terms:
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Tonsillitis Pharyngitis Pharyngeal Diseases Stomatognathic Diseases |
Respiratory Tract Infections Respiratory Tract Diseases Otorhinolaryngologic Diseases |