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Completed

NCT Number: NCT01330147

HPV Prevalence in the Mouth and Oropharynx of the Tonsillectomy Population

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.

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Key information

Conditions

Chronic Tonsillitis Head and Neck Neoplasms Mouth Diseases Mouth Neoplasms Neoplasms Neoplasms by Site Oropharyngeal Neoplasms Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pharyngeal Diseases Pharyngeal Neoplasms Stomatognathic Diseases

Age range

Up to 65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospitals Coventry & Warwickshire Trust, Coventry, England, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Occurrence of HPV in tonsils and in oral scrape sample

    Time frame: 36 months

    Presence of HPV result

Secondary outcomes

  1. HPV vaccination status

    Time frame: 36 months

    vaccination received yes/no and the type of vaccination description

Sponsors and collaborators

Lead sponsor

University of Birmingham

Other

Collaborators

  • GlaxoSmithKline

Registry information

Acronym: Oromouth

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Apr 6, 2011
Registry last updated
May 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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