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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2015 by University of Birmingham
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
University of Birmingham
ClinicalTrials.gov Identifier:
NCT01330147
First received: April 1, 2011
Last updated: July 9, 2015
Last verified: July 2015
  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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • HPV vaccination status [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Oral rinse, Oral Mucosal Trasudate, Urine, Whole Blood, Nail brushings, Mouth brush biopsies (scrapes) and Tonsillectomy specimens


Estimated Enrollment: 925
Study Start Date: March 2013
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 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
Genders Eligible for Study:   Both
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

Contacts
Contact: Hisham Mehanna, Prof +441214146547 h.mehanna@bham.ac.uk
Contact: Anjola Awofisoye, Msc +441214149021 a.awofisoye@bham.ac.uk

Locations
United Kingdom
University Hospitals Coventry & Warwickshire Trust Recruiting
Coventry, England, United Kingdom, CV2 2DX
Contact: Rachael O'Beney    02476 965248    Rachael.O'Beney@uhcw.nhs.uk   
Principal Investigator: Rejali Darius         
University Hospital Birmingham Recruiting
Birmingham, West Midlands, United Kingdom, B15 2GW
Contact: June Jones    0121 414 9276    June.Jones@uhb.nhs.uk   
Birmingham Children Hospital Recruiting
Birmingham, United Kingdom, B4 6NH
Contact: Gemma Grosvenor    01213339155    Gemma.Grosvenor@bch.nhs.uk   
Principal Investigator: Annlouise McDermott         
Birmingham City Hospital Recruiting
Birmingham, United Kingdom, B18 7QH
Contact: Brian Gammon    0121 507 3621    brian.gammon@nhs.net   
Principal Investigator: Uday Kale         
Heartlands Hospital Recruiting
Birmingham, United Kingdom, B9 5SS
Contact: Semsem Abdulle    +441214243262    semsem.abdulle@heartofengland.nhs.uk   
Principal Investigator: Shahram Anari         
Kidderminster Hospital Recruiting
Kidderminster, United Kingdom, DY11 6RJ
Contact: Kim McDonalds    01905 760825    kim.macdonald2@nhs.net   
Principal Investigator: Chris Ayshford         
New Cross Hospital Recruiting
Wolverhampton, United Kingdom, WV10 0QP
Contact: Naz Begum    01902 307999    nazbegum@nhs.net   
Principal Investigator: Catherine Spinou         
Worcestershire Royal Hospital Recruiting
Worcester, United Kingdom, WR5 1DD
Contact: Kim McDonalds    01905 760825    kim.macdonald2@nhs.net   
Principal Investigator: Chris Ayshford         
Sponsors and Collaborators
University of Birmingham
GlaxoSmithKline
Investigators
Principal Investigator: Hisham Mehanna, Prof The University of Birmingham
  More Information

No publications provided

Responsible Party: University of Birmingham
ClinicalTrials.gov Identifier: NCT01330147     History of Changes
Other Study ID Numbers: RG12-208, 12344
Study First Received: April 1, 2011
Last Updated: July 9, 2015
Health Authority: United Kingdom: National Health Service

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

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

ClinicalTrials.gov processed this record on August 02, 2015