Trial record 17 of 46 for:    Open Studies | tonsillectomy

Human Papilloma Virus (HPV) Prevalence in the Mouth and Oropharynx of the General Population (Oromouth)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2011 by University Hospitals Coventry and Warwickshire NHS Trust
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
University Hospitals Coventry and Warwickshire NHS Trust
ClinicalTrials.gov Identifier:
NCT01330147
First received: April 1, 2011
Last updated: April 5, 2011
Last verified: March 2011
  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 costeffectiveness 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 General Population

Resource links provided by NLM:


Further study details as provided by University Hospitals Coventry and Warwickshire NHS Trust:

Primary Outcome Measures:
  • Occurrence of HPV in tonsils and in oral scrape sample [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • HPV vaccination status [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Saliva, Urine, Whole Blood, Mouth brush biopsies (scrapes) and tonsillectomy specimens


Estimated Enrollment: 1250
Study Start Date: August 2011
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2014 (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, oral mucosal scrappings and a tonsillectomy will be performed and all the samples will be processed for evidence of HPV infection.

  Eligibility

Ages Eligible for Study:   1 Year to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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 55 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, PhD +44 - 2476965244 hishammehanna@aol.com
Contact: Rehan Kazi, PhD +44 - 2476965249 rehan.kazi@uhcw.nhs.uk

Locations
United Kingdom
University Hospitals Coventry Not yet recruiting
Coventry, England, United Kingdom, CV2 2DX
Principal Investigator: Hisham Mehanna, PhD         
Sub-Investigator: Rehan Kazi, PhD         
Sponsors and Collaborators
University Hospitals Coventry and Warwickshire NHS Trust
GlaxoSmithKline
Investigators
Principal Investigator: Hisham Mehanna, FRCS, PhD University Hospitals Coventry and Warwickshire NHS Trust
  More Information

No publications provided

Responsible Party: Ms. Sylvia Taylor, GSK Biologicals
ClinicalTrials.gov Identifier: NCT01330147     History of Changes
Other Study ID Numbers: HM086011
Study First Received: April 1, 2011
Last Updated: April 5, 2011
Health Authority: United Kingdom: National Health Service

Keywords provided by University Hospitals Coventry and Warwickshire NHS Trust:
HPV
oral cancer
oropharyngeal cancer
tonsillectomy

Additional relevant MeSH terms:
Tonsillitis
Chronic Disease
Pharyngitis
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on July 28, 2014