HPV Prevalence in the Mouth and Oropharynx of the Tonsillectomy Population (Oromouth)
This study is currently recruiting participants.
(see Contacts and Locations)
Verified July 2015 by University of Birmingham
Sponsor:
University of Birmingham
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
University of Birmingham
ClinicalTrials.gov Identifier:
NCT01330147
First received: April 1, 2011
Last updated: July 9, 2015
Last verified: July 2015
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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 cost effectiveness 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 Tonsillectomy Population |
Resource links provided by NLM:
Further study details as provided by University of Birmingham:
Primary Outcome Measures:
- Occurrence of HPV in tonsils and in oral scrape sample [ Time Frame: 36 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- HPV vaccination status [ Time Frame: 36 months ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Oral rinse, Oral Mucosal Trasudate, Urine, Whole Blood, Nail brushings, Mouth brush biopsies (scrapes) and Tonsillectomy specimens
| Estimated Enrollment: | 925 |
| Study Start Date: | March 2013 |
| Estimated Study Completion Date: | November 2015 |
| Estimated Primary Completion Date: | November 2015 (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, oropharyngeal brushings and a tonsillectomy will be performed and all the samples will be processed for evidence of HPV infection.
Eligibility| Ages Eligible for Study: | up to 65 Years (Child, Adult) |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01330147
Please refer to this study by its ClinicalTrials.gov identifier: NCT01330147
Contacts
| Contact: Hisham Mehanna, Prof | +441214146547 | h.mehanna@bham.ac.uk | |
| Contact: Anjola Awofisoye, Msc | +441214149021 | a.awofisoye@bham.ac.uk |
Locations
| United Kingdom | |
| University Hospitals Coventry & Warwickshire Trust | Recruiting |
| Coventry, England, United Kingdom, CV2 2DX | |
| Contact: Rachael O'Beney 02476 965248 Rachael.O'Beney@uhcw.nhs.uk | |
| Principal Investigator: Rejali Darius | |
| University Hospital Birmingham | Recruiting |
| Birmingham, West Midlands, United Kingdom, B15 2GW | |
| Contact: June Jones 0121 414 9276 June.Jones@uhb.nhs.uk | |
| Birmingham City Hospital | Recruiting |
| Birmingham, United Kingdom, B18 7QH | |
| Contact: Brian Gammon 0121 507 3621 brian.gammon@nhs.net | |
| Principal Investigator: Uday Kale | |
| Birmingham Children Hospital | Recruiting |
| Birmingham, United Kingdom, B4 6NH | |
| Contact: Gemma Grosvenor 01213339155 Gemma.Grosvenor@bch.nhs.uk | |
| Principal Investigator: Annlouise McDermott | |
| Heartlands Hospital | Recruiting |
| Birmingham, United Kingdom, B9 5SS | |
| Contact: Semsem Abdulle +441214243262 semsem.abdulle@heartofengland.nhs.uk | |
| Principal Investigator: Shahram Anari | |
| Kidderminster Hospital | Recruiting |
| Kidderminster, United Kingdom, DY11 6RJ | |
| Contact: Kim McDonalds 01905 760825 kim.macdonald2@nhs.net | |
| Principal Investigator: Chris Ayshford | |
| New Cross Hospital | Recruiting |
| Wolverhampton, United Kingdom, WV10 0QP | |
| Contact: Naz Begum 01902 307999 nazbegum@nhs.net | |
| Principal Investigator: Catherine Spinou | |
| Worcestershire Royal Hospital | Recruiting |
| Worcester, United Kingdom, WR5 1DD | |
| Contact: Kim McDonalds 01905 760825 kim.macdonald2@nhs.net | |
| Principal Investigator: Chris Ayshford | |
Sponsors and Collaborators
University of Birmingham
GlaxoSmithKline
Investigators
| Principal Investigator: | Hisham Mehanna, Prof | The University of Birmingham |
More Information
| Responsible Party: | University of Birmingham |
| ClinicalTrials.gov Identifier: | NCT01330147 History of Changes |
| Other Study ID Numbers: | RG12-208 12344 |
| Study First Received: | April 1, 2011 |
| Last Updated: | July 9, 2015 |
| Health Authority: | United Kingdom: National Health Service |
Keywords provided by University of Birmingham:
|
HPV oral cancer oropharyngeal cancer tonsillectomy |
Additional relevant MeSH terms:
|
Tonsillitis Pharyngitis Pharyngeal Diseases Stomatognathic Diseases |
Respiratory Tract Infections Respiratory Tract Diseases Otorhinolaryngologic Diseases |
ClinicalTrials.gov processed this record on September 28, 2016