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

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
University of Birmingham
ClinicalTrials.gov Identifier:
NCT01330147
First received: April 1, 2011
Last updated: May 16, 2017
Last verified: May 2017
  Purpose
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.

Condition
Chronic Tonsillitis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: HPV Prevalence in the Mouth and Oropharynx of the Tonsillectomy Population

Resource links provided by NLM:


Further study details as provided by University of Birmingham:

Primary Outcome Measures:
  • Occurrence of HPV in tonsils and in oral scrape sample [ Time Frame: 36 months ]
    Presence of HPV result


Secondary Outcome Measures:
  • HPV vaccination status [ Time Frame: 36 months ]
    vaccination received yes/no and the type of vaccination description


Biospecimen Retention:   Samples With DNA
Oral rinse, Oral Mucosal Trasudate, Urine, Whole Blood, Nail brushings, Mouth brush biopsies (scrapes) and Tonsillectomy specimens

Enrollment: 937
Study Start Date: March 2013
Study Completion Date: September 28, 2015
Primary Completion Date: September 28, 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Tonsillectomy
Subjects undergoing tonsillectomy for non-cancer reasons including operations for: recurrent tonsillitis, asymmetric tonsils, snoring surgery or obstructive sleep apnoea.

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.
  Eligibility

Ages Eligible for Study:   up to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01330147

Locations
United Kingdom
University Hospitals Coventry & Warwickshire Trust
Coventry, England, United Kingdom, CV2 2DX
University Hospital Birmingham
Birmingham, West Midlands, United Kingdom, B15 2GW
Birmingham City Hospital
Birmingham, United Kingdom, B18 7QH
Birmingham Children Hospital
Birmingham, United Kingdom, B4 6NH
Heartlands Hospital
Birmingham, United Kingdom, B9 5SS
Kidderminster Hospital
Kidderminster, United Kingdom, DY11 6RJ
New Cross Hospital
Wolverhampton, United Kingdom, WV10 0QP
Worcestershire Royal Hospital
Worcester, United Kingdom, WR5 1DD
Sponsors and Collaborators
University of Birmingham
GlaxoSmithKline
Investigators
Principal Investigator: Hisham Mehanna, Prof The University of Birmingham
  More Information

Responsible Party: University of Birmingham
ClinicalTrials.gov Identifier: NCT01330147     History of Changes
Other Study ID Numbers: RG12-208
12344 ( Other Identifier: NIHR )
Study First Received: April 1, 2011
Last Updated: May 16, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by University of Birmingham:
HPV
oral cancer
oropharyngeal cancer
tonsillectomy

Additional relevant MeSH terms:
Tonsillitis
Pharyngitis
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on August 18, 2017