Investigation Into the Infectivity Levels of Human Papilloma Virus (HPV) in Tonsillar Tissue

NCT ID: NCT02841631

Last Updated: 2019-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-01

Study Completion Date

2020-10-31

Brief Summary

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Human Papilloma Virus (HPV) has been shown to be a cause of Head \& Neck Squamous Cell Carcinoma (HNSCC) and the majority of current studies focus on what is happening in patients with a HPV HNSCC. But there is limited investigation into HPV infection in the oropharynx of patients who do not have HNSCC. The current incidence of oral HPV infection is not known in the general population locally and there is also limited information on what particular localities within the mouth that patients' harbour HPV infection what strains are present and if there are any differences in viral load.

Therefore the aim of this project is to investigate within patients that undergo tonsillectomies the rate of HPV infection in tonsils to determine the amount of HPV present within the community.

Detailed Description

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Patients are having no additional invasive testing than is all ready being carried out for their care pertaining to their tonsillar tissue. Patients are routinely swabbed pre-operative for evidence of MRSA, this trial would add an extra swabbing procedure for the mouth.

The ethical implications are related to the tissue which is being tested for a virus that can be implicated in head and neck squamous cancer. These patients would not normally be aware of HPV infection and this would raise an new health burden in these patient who are likely to be fit and well. The research team would be suitable to counsel patients from any worries related to HPV infection.

Conditions

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Human Papillomavirus, Palatine Tonsil

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Post-Tonsillectomy

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

HPV status and typing of tissue

Intervention Type GENETIC

HPV status and typing of tissue

Interventions

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HPV status and typing of tissue

HPV status and typing of tissue

Intervention Type GENETIC

Eligibility Criteria

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Inclusion Criteria

* All patients undergoing routine tonsillectomies who can provide consent to participate over the age of 18 years old would eligible to enter the study. They would all ready be listed for a tonsillectomy after being seen by an ENT surgeon.

Exclusion Criteria

* Patients unable to give informed consent
* If the tonsillectomy is carried out to diagnose cancer
* Patient chooses to decline recruitment into the study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Derby

OTHER

Sponsor Role lead

Responsible Party

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Raguwinder Sahota

Associate Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Royal Derby Hospital

Derby, Derbyshire, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Facility Contacts

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Raguwinder S Sahota, MBChB MRCS DoHNS MD FRCS (ORL)

Role: primary

01332592094

Elizabeth Marsh, phD

Role: backup

01332592094

Other Identifiers

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IRAS 194857

Identifier Type: -

Identifier Source: org_study_id

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