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

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.

Study Overview

• Status: Unknown
• Conditions: Human Papillomavirus, Palatine Tonsil
• Intervention / Treatment: Genetic: HPV status and typing of tissue

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 Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

Study Locations

• United Kingdom
  • Derbyshire
    • Derby, Derbyshire, United Kingdom, DE22 3NE
      • Recruiting
      • Royal Derby Hospital
      • Contact: Raguwinder S Sahota, MBChB MRCS DoHNS MD FRCS (ORL); Phone Number: 01332592094; Email: rss37@le.ac.uk
      • Contact: Elizabeth Marsh, phD; Phone Number: 01332592094; Email: E.Marsh@derby.ac.uk
      • Principal Investigator: Raguwinder S Sahota, MBChB MRCS DoHNS MD FRCS (ORL)
      • Sub-Investigator: Elizabeth Marsh, PhD
      • Sub-Investigator: Gillian Knight, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing a routine tonsillectomy operation for non-cancerous reasons at the hospital will be recruited for this study.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of oral and tonsillar HPV infection in patients undergoing tonsillectomies and to investigate any links with lifestyle.	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.	over the 3 years of the study

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	over the 3 years of the study
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.	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.	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.	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

Collaborators and Investigators

• Sponsor: University of Derby

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2018
• Primary Completion (Anticipated): July 1, 2020
• Study Completion (Anticipated): October 1, 2020

Study Registration Dates

• First Submitted: July 15, 2016
• First Submitted That Met QC Criteria: July 21, 2016
• First Posted (Estimate): July 22, 2016

Study Record Updates

• Last Update Posted (Actual): May 3, 2019
• Last Update Submitted That Met QC Criteria: May 1, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Squamous Cell; Papilloma
• Other Study ID Numbers: IRAS 194857

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED