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

May 16, 2017 updated by: University of Birmingham
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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

937

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Birmingham, United Kingdom, B18 7QH
        • Birmingham City Hospital
      • Birmingham, United Kingdom, B9 5SS
        • Heartlands Hospital
      • Birmingham, United Kingdom, B4 6NH
        • Birmingham Children Hospital
      • Kidderminster, United Kingdom, DY11 6RJ
        • Kidderminster Hospital
      • Wolverhampton, United Kingdom, WV10 0QP
        • New Cross Hospital
      • Worcester, United Kingdom, WR5 1DD
        • Worcestershire Royal Hospital
    • England
      • Coventry, England, United Kingdom, CV2 2DX
        • University Hospitals Coventry & Warwickshire Trust
    • West Midlands
      • Birmingham, West Midlands, United Kingdom, B15 2GW
        • University Hospital Birmingham

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Birmingham

Collaborators

GlaxoSmithKline

Investigators

  • Principal Investigator: Hisham Mehanna, Prof, The University of Birmingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

September 28, 2015

Study Completion (Actual)

September 28, 2015

Study Registration Dates

First Submitted

April 1, 2011

First Submitted That Met QC Criteria

April 5, 2011

First Posted (Estimate)

April 6, 2011

Study Record Updates

Last Update Posted (Actual)

May 18, 2017

Last Update Submitted That Met QC Criteria

May 16, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RG12-208
  • 12344 (Other Identifier: NIHR)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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