HPV Prevalence in the Mouth and Oropharynx of the Tonsillectomy Population

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01330147

Acronym

Oromouth

Enrollment

937

Registered

2011-04-06

Start date

2013-03-31

Completion date

2015-09-28

Last updated

2017-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Tonsillitis

Keywords

HPV, oral cancer, oropharyngeal cancer, tonsillectomy

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 65 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Occurrence of HPV in tonsils and in oral scrape sample	36 months	Presence of HPV result

Secondary

Measure	Time frame	Description
HPV vaccination status	36 months	vaccination received yes/no and the type of vaccination description

Countries

United Kingdom

Outcome results