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

University of Derby

Status: Unknown

Conditions: Human Papillomavirus, Palatine Tonsil

Treatments: Genetic: HPV status and typing of tissue

Study type: Observational

Funder types: Other

Identifiers

NCT02841631

IRAS 194857

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

300 participants in 1 patient group

Post-Tonsillectomy

Description:

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

Treatment:

Genetic: HPV status and typing of tissue