HPV Prevalence in the Mouth and Oropharynx of the Tonsillectomy Population

Chronic Tonsillitis Clinical Trial

— Oromouth  

Official title:

HPV Prevalence in the Mouth and Oropharynx of the Tonsillectomy Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01330147
• Other study ID #: RG12-208
• Secondary ID: 12344
• Status: Completed
• Phase: N/A
• First received: April 1, 2011
• Last updated: May 16, 2017
• Start date: March 2013
• Est. completion date: September 28, 2015

Study information

• Verified date: May 2017
• Source: University of Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 937
• Est. completion date: September 28, 2015
• Est. primary completion date: September 28, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Tonsillitis
• Tonsillitis

Locations

Country	Name	City	State
United Kingdom	Birmingham Children Hospital	Birmingham
United Kingdom	Birmingham City Hospital	Birmingham
United Kingdom	Heartlands Hospital	Birmingham
United Kingdom	University Hospital Birmingham	Birmingham	West Midlands
United Kingdom	University Hospitals Coventry & Warwickshire Trust	Coventry	England
United Kingdom	Kidderminster Hospital	Kidderminster
United Kingdom	New Cross Hospital	Wolverhampton
United Kingdom	Worcestershire Royal Hospital	Worcester

Sponsors (2)

Lead Sponsor	Collaborator
University of Birmingham	GlaxoSmithKline

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of HPV in tonsils and in oral scrape sample	Presence of HPV result	36 months
Secondary	HPV vaccination status	vaccination received yes/no and the type of vaccination description	36 months