Human Papillomavirus, Palatine TonsilNCT02841631
Investigation Into the Infectivity Levels of Human Papilloma Virus (HPV) in Tonsillar Tissue
An observational study of Human Papillomavirus, Palatine Tonsil, run by University of Derby at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Human Papillomavirus, Palatine Tonsil
- What is being tested?
- HPV status and typing of tissue
- How many people
- 300 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jul 2018to Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing a routine tonsillectomy operation for non-cancerous reasons at the hospital will be recruited for this study.
Who may be able to join
- 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.
Who cannot join
- Patients unable to give informed consent
- If the tonsillectomy is carried out to diagnose cancer
- Patient chooses to decline recruitment into the study
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Royal Derby Hospital
Derby, Derbyshire, DE22 3NE
Raguwinder S Sahota, MBChB MRCS DoHNS MD FRCS (ORL), 01332592094, rss37@le.ac.uk
Elizabeth Marsh, phD, 01332592094, E.Marsh@derby.ac.uk
About this study
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.
Read the 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.
- Conditions
- Human Papillomavirus, Palatine Tonsil
- Being tested
- HPV status and typing of tissue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPV status and typing of tissueGenetic
HPV status and typing of tissue
| Study group | Role | What they receive |
|---|---|---|
| Post-Tonsillectomy | Subjects undergoing tonsillectomy for non-cancer reasons including operations for: recurrent tonsillitis, asymmetric tonsils, snoring surgery or obstructive sleep apnoea. Receives: Genetic: HPV status and typing of tissue |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 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.
Measured: 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.
Measured: over the 3 years of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2016 (estimated)
- Study start1 Jul 2018
- Primary completionJul 2020 (estimated)
- Study completionOct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Papillomavirus, Palatine TonsilStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Derby
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raguwinder Sahota, University of Derby
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02841631
- Sponsor's protocol ID
- IRAS 194857
- Status last verified
- May 2019
- First submitted
- 15 Jul 2016
- Last updated
- 3 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation Into the Infectivity Levels of Human Papilloma Virus (HPV) in Tonsillar Tissue
- ClinicalTrials.gov ID
- NCT02841631
- Acronym / sponsor ID
- IRAS 194857
- Conditions
- Human Papillomavirus, Palatine Tonsil
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of DerbyUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- Jul 2020 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 22 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Post-Tonsillectomy | – | Genetic: HPV status and typing of tissueSubjects undergoing tonsillectomy for non-cancer reasons including operations for: recurrent tonsillitis, asymmetric tonsils, snoring surgery or obstructive sleep apnoea. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing a routine tonsillectomy operation for non-cancerous reasons at the hospital will be recruited for this study.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- Patients unable to give informed consent
- If the tonsillectomy is carried out to diagnose cancer
- Patient chooses to decline recruitment into the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HPV status and typing of tissueHPV status and typing of tissue | Genetic | Post-Tonsillectomy |
Primary outcome
Rate of oral and tonsillar HPV infection in patients undergoing tonsillectomies and to investigate any links with lifestyle.
Time frame: over the 3 years of the study
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.
3 secondary outcomes
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.
Time frame: 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.
Time frame: 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.
Time frame: over the 3 years of the study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Human Papillomavirus, Palatine Tonsil, run by University of Derby at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of oral and tonsillar HPV infection in patients undergoing tonsillectomies and to investigate any links with lifestyle. (time frame: over the 3 years of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2019.