HPV Prevalence in the Mouth and Oropharynx of the Tonsillectomy Population

Completed

• Conditions: Chronic Tonsillitis

• Registration Number: NCT01330147
• Lead Sponsor: University of Birmingham

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.

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.

Study Timeline

• Study First Submitted: 2011-04-01
• Study First Submitted QC: 2011-04-05
• Study First Posted: 2011-04-06
• Study Start: 2013-03
• Primary Completion: 2015-09-28
• Study Completion: 2015-09-28
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-16
• Last Update Posted: 2017-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 937

Inclusion Criteria

1. Subjects undergoing tonsillectomy for non cancer reasons including operations for: recurrent tonsillitis, asymmetric tonsils, snoring surgery or obstructive sleep apnoea
2. Age - 0 to 65 years
3. Subject or legal guardian has given informed written consent

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Exclusion Criteria

1. Subjects undergoing adenoidectomy alone with no tonsillectomy
2. 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
3. Learning disability preventing an adult over 16 years old from giving their own consent

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Occurrence of HPV in tonsils and in oral scrape sample	36 months	Presence of HPV result

Secondary Outcome Measures

Name	Time	Method
HPV vaccination status	36 months	vaccination received yes/no and the type of vaccination description

Trial Locations

Locations (8)

New Cross Hospital; 🇬🇧 Wolverhampton, United Kingdom

Heartlands Hospital; 🇬🇧 Birmingham, United Kingdom

Birmingham Children Hospital; 🇬🇧 Birmingham, United Kingdom

Worcestershire Royal Hospital; 🇬🇧 Worcester, United Kingdom

University Hospital Birmingham; 🇬🇧 Birmingham, West Midlands, United Kingdom

University Hospitals Coventry & Warwickshire Trust; 🇬🇧 Coventry, England, United Kingdom

Birmingham City Hospital; 🇬🇧 Birmingham, United Kingdom

Kidderminster Hospital; 🇬🇧 Kidderminster, United Kingdom