Clinical trial NCT01330147: HPV Prevalence in the Mouth and Oropharynx of the Tonsillectomy Population
Official title: HPV Prevalence in the Mouth and Oropharynx of the Tonsillectomy Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Tonsillitis
Keywords: HPV
oral cancer
oropharyngeal cancer
tonsillectomy
Lead sponsor: University of Birmingham
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2011-04-06
Enrollment: 937
Sex: ALL
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

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

Primary outcomes:
measure: Occurrence of HPV in tonsils and in oral scrape sample
timeFrame: 36 months
Secondary outcomes:
measure: HPV vaccination status
timeFrame: 36 months
Other outcomes:
Locations:
city: Coventry
country: United Kingdom
facility: University Hospitals Coventry & Warwickshire Trust
state: England
city: Birmingham
country: United Kingdom
facility: University Hospital Birmingham
state: West Midlands
city: Birmingham
country: United Kingdom
facility: Birmingham City Hospital
city: Birmingham
country: United Kingdom
facility: Birmingham Children Hospital
city: Birmingham
country: United Kingdom
facility: Heartlands Hospital
city: Kidderminster
country: United Kingdom
facility: Kidderminster Hospital
city: Wolverhampton
country: United Kingdom
facility: New Cross Hospital
city: Worcester
country: United Kingdom
facility: Worcestershire Royal Hospital
Study officials:
affiliation: The University of Birmingham
name: Hisham Mehanna, Prof
role: PRINCIPAL_INVESTIGATOR
References: