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

NCT02841631 | Unknown DMC

• 1 other identifier: IRAS 194857
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Human Papillomavirus, Palatine Tonsil

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

• 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

• 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

Study Arms (1)

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

Interventions

HPV status and typing of tissue GENETIC

HPV status and typing of tissue

Post-Tonsillectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Derby: lead

Study Sites (1)

Royal Derby Hospital

Derby, Derbyshire, DE22 3NE, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Oral rinse and Tonsillectomy specimens

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Lecturer

Study Record Dates

• First Submitted: July 15, 2016
• First Posted: July 22, 2016
• Study Start: July 1, 2018
• Primary Completion: July 1, 2020
• Study Completion: October 1, 2020
• Last Updated: May 3, 2019

Record last verified: 2019-05

Locations

GB (1)