HPV Prevalence in the Mouth and Oropharynx of the Tonsillectomy Population
Oromouth
2 other identifiers
observational
937
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2013
Typical duration for all trials
8 active sites
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 1, 2011
CompletedFirst Posted
Study publicly available on registry
April 6, 2011
CompletedStudy Start
First participant enrolled
March 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 28, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 28, 2015
CompletedMay 18, 2017
May 1, 2017
2.6 years
April 1, 2011
May 16, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Occurrence of HPV in tonsils and in oral scrape sample
Presence of HPV result
36 months
Secondary Outcomes (1)
HPV vaccination status
36 months
Study Arms (1)
Tonsillectomy
Subjects undergoing tonsillectomy for non-cancer reasons including operations for: recurrent tonsillitis, asymmetric tonsils, snoring surgery or obstructive sleep apnoea.
Eligibility Criteria
Patients undergoing a tonsillectomy operation for non-cancerous reasons at the hospital will be recruited for this study.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Birminghamlead
- GlaxoSmithKlinecollaborator
Study Sites (8)
University Hospitals Coventry & Warwickshire Trust
Coventry, England, CV2 2DX, United Kingdom
University Hospital Birmingham
Birmingham, West Midlands, B15 2GW, United Kingdom
Birmingham City Hospital
Birmingham, B18 7QH, United Kingdom
Birmingham Children Hospital
Birmingham, B4 6NH, United Kingdom
Heartlands Hospital
Birmingham, B9 5SS, United Kingdom
Kidderminster Hospital
Kidderminster, DY11 6RJ, United Kingdom
New Cross Hospital
Wolverhampton, WV10 0QP, United Kingdom
Worcestershire Royal Hospital
Worcester, WR5 1DD, United Kingdom
Biospecimen
Oral rinse, Oral Mucosal Trasudate, Urine, Whole Blood, Nail brushings, Mouth brush biopsies (scrapes) and Tonsillectomy specimens
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hisham Mehanna, Prof
The University of Birmingham
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 1, 2011
First Posted
April 6, 2011
Study Start
March 1, 2013
Primary Completion
September 28, 2015
Study Completion
September 28, 2015
Last Updated
May 18, 2017
Record last verified: 2017-05