HPV Prevalence in the Mouth and Oropharynx of the Tonsillectomy Population (Oromouth)

University of Birmingham

Status: Completed

Conditions: Chronic Tonsillitis

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01330147

12344 (Other Identifier)

RG12-208

Details and patient eligibility

About

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.

Full 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.

Enrollment: 937 patients

Sex: All

Ages: Under 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

937 participants in 1 patient group

Tonsillectomy

Description:

Subjects undergoing tonsillectomy for non-cancer reasons including operations for: recurrent tonsillitis, asymmetric tonsils, snoring surgery or obstructive sleep apnoea.