Clinical trial NCT02841631: Investigation Into the Infectivity Levels of Human Papilloma Virus (HPV) in Tonsillar Tissue
Official title: Investigation Into the Infectivity Levels of Human Papilloma Virus (HPV) in Tonsillar Tissue
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Human Papillomavirus, Palatine Tonsil
Lead sponsor: University of Derby
Sponsor class: OTHER
First posted: 2016-07-22
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of oral and tonsillar HPV infection in patients undergoing tonsillectomies and to investigate any links with lifestyle.
timeFrame: over the 3 years of the study
Secondary outcomes:
measure: 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.
timeFrame: over the 3 years of the study
measure: 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.
timeFrame: over the 3 years of the study
measure: 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.
timeFrame: over the 3 years of the study
Other outcomes:
Locations:
city: Derby
country: United Kingdom
facility: Royal Derby Hospital
state: Derbyshire
Study officials:
References: