Human Papillomavirus, Palatine Tonsil Clinical Trial
Official title:
Investigation Into the Infectivity Levels of Human Papilloma Virus (HPV) in Tonsillar Tissue
| NCT number | NCT02841631 |
| Other study ID # | IRAS 194857 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | July 1, 2018 |
| Est. completion date | October 2020 |
| Verified date | May 2019 |
| Source | University of Derby |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Recruiting |
| Enrollment | 300 |
| Est. completion date | October 2020 |
| Est. primary completion date | July 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | Royal Derby Hospital | Derby | Derbyshire |
| Lead Sponsor | Collaborator |
|---|---|
| University of Derby |
United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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 | |
| Secondary | 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 | |
| Secondary | 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 |