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

• Conditions: Human Papillomavirus, Palatine Tonsil
• Interventions: Genetic: HPV status and typing of tissue

• Registration Number: NCT02841631
• Lead Sponsor: University of Derby

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2016-07-15
• Study First Submitted QC: 2016-07-21
• Study First Posted: 2016-07-22
• Study Start: 2018-07-01
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-01
• Last Update Posted: 2019-05-03
• Primary Completion: 2020-07
• Study Completion: 2020-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Post-Tonsillectomy	HPV status and typing of tissue	Subjects undergoing tonsillectomy for non-cancer reasons including operations for: recurrent tonsillitis, asymmetric tonsils, snoring surgery or obstructive sleep apnoea.

Primary Outcome Measures

Name	Time	Method
Rate of oral and tonsillar HPV infection in patients undergoing tonsillectomies and to investigate any links with lifestyle.	over the 3 years of the study	The aim of this project is to examine the rate of oral and tonsillar HPV infection in patients undergoing tonsillectomies and to investigate any links with lifestyle.

Secondary Outcome Measures

Name	Time	Method
Quantification and typing via quantitative PCR of detectable HPV infection from saliva and tonsillar samples to investigate any differences between samples from the same patient and also different patients.	over the 3 years of the study	Quantification and typing of detectable HPV infection from saliva and tonsillar samples to investigate any differences between samples from the same patient and also different patients.
Examination of viral load and also expression levels of the HPV viral oncogenes (E6 and E7) from infected tissue to investigate any differences in protein expression between different patients.	over the 3 years of the study	Examination of viral load and also expression levels of the HPV viral oncogenes, E6 and E7, from infected tissue to investigate any differences in protein expression between different patients.
Validation of a reproducible oral HPV screening method to detect HPV from saliva samples and also tonsillar tissue to investigate rates of oral HPV infection.	over the 3 years of the study	Validation of a reproducible oral HPV screening method to detect HPV from saliva samples and also tonsillar tissue to investigate rates of oral HPV infection. The investigators will be using quantitative PCR to detect the strains of HPV and the viral load.

Trial Locations

Locations (1)

Royal Derby Hospital; 🇬🇧 Derby, Derbyshire, United Kingdom