Chronic TonsillitisOromouthNCT01330147
HPV Prevalence in the Mouth and Oropharynx of the Tonsillectomy Population
An observational study of Chronic Tonsillitis, run by University of Birmingham at 8 sites in United Kingdom.
Trial summary
The principal aim of this study is to provide vital current data on the prevalence, distribution and natural history of Human Papilloma Virus (HPV) infection in the mouth. This data is an essential requirement for the assessment, development and evaluation of cost effectiveness of prophylactic vaccination and… Read more about this study
- Who is it for?
- Ages Up to 65 years
- Conditions the study is for
- Chronic Tonsillitis
- How many people
- 937 participants
- Where
- 8 sitesUnited Kingdom
- Study dates
- Mar 2013to 28 Sep 2015
- 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 Up to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients undergoing a tonsillectomy operation for non-cancerous reasons at the hospital will be recruited for this study.
Who may be able to join
- Subjects undergoing tonsillectomy for non cancer reasons including operations for: recurrent tonsillitis, asymmetric tonsils, snoring surgery or obstructive sleep apnoea
- Age - 0 to 65 years
- Subject or legal guardian has given informed written consent
Who cannot join
- Subjects undergoing adenoidectomy alone with no tonsillectomy
- Subjects with previous oropharyngeal cancer or oral cancer, or any other head and neck cancer such as nasopharyngeal or laryngeal cancer that is currently undergoing or has previously been diagnosed or treated
- Learning disability preventing an adult over 16 years old from giving their own consent
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United Kingdom8 sites
University Hospital Birmingham
Birmingham, West Midlands, B15 2GW
Birmingham City Hospital
Birmingham, B18 7QH
Birmingham Children Hospital
Birmingham, B4 6NH
Heartlands Hospital
Birmingham, B9 5SS
University Hospitals Coventry & Warwickshire Trust
Coventry, England, CV2 2DX
Kidderminster Hospital
Kidderminster, DY11 6RJ
New Cross Hospital
Wolverhampton, WV10 0QP
Worcestershire Royal Hospital
Worcester, WR5 1DD
About this study
The principal aim of this study is to provide vital current data on the prevalence, distribution and natural history of Human Papilloma Virus (HPV) infection in the mouth. This data is an essential requirement for the assessment, development and evaluation of cost effectiveness of prophylactic vaccination and screening programmes.
Read the detailed description
Patients undergoing a tonsillectomy operation for non-cancerous reasons will be recruited for this study. They will be asked to complete two questionnaires (study and sexual practices), provide saliva, urine and a blood sample. Following anaesthesia, oropharyngeal brushings and a tonsillectomy will be performed and all the samples will be processed for evidence of HPV infection.
- Conditions
- Chronic Tonsillitis
- Keywords
- HPV, oral cancer, oropharyngeal cancer, tonsillectomy
- Medical subject headings
- Mouth Neoplasms, Oropharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Tonsillectomy | Subjects undergoing tonsillectomy for non-cancer reasons including operations for: recurrent tonsillitis, asymmetric tonsils, snoring surgery or obstructive sleep apnoea. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of HPV in tonsils and in oral scrape sample
Presence of HPV result
Measured: 36 months
Secondary outcomes (1)
HPV vaccination status
vaccination received yes/no and the type of vaccination description
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2011 (estimated)
- Study startMar 2013
- Primary completion28 Sep 2015
- Study completion28 Sep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic TonsillitisStudies 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
- 937 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- Hisham Mehanna, Prof, Principal investigator, The University of Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01330147
- Sponsor's protocol ID
- RG12-208
- Other IDs
- 12344
- Acronym
- Oromouth
- Status last verified
- May 2017
- First submitted
- 1 Apr 2011
- Last updated
- 18 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HPV Prevalence in the Mouth and Oropharynx of the Tonsillectomy Population
- ClinicalTrials.gov ID
- NCT01330147
- Acronym / sponsor ID
- Oromouth / RG12-208
- Conditions
- Chronic Tonsillitis
- Keywords
- HPV, oral cancer, oropharyngeal cancer, tonsillectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 937 participants (actual)
- Lead sponsor
- University of BirminghamUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Mar 2013
- Primary completion
- 28 Sep 2015 (actual)
- Study completion
- 28 Sep 2015 (actual)
- First posted
- 6 Apr 2011 (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.
The principal aim of this study is to provide vital current data on the prevalence, distribution and natural history of Human Papilloma Virus (HPV) infection in the mouth. This data is an essential requirement for the assessment, development and evaluation of cost effectiveness of prophylactic vaccination and screening programmes.
Detailed description
Patients undergoing a tonsillectomy operation for non-cancerous reasons will be recruited for this study. They will be asked to complete two questionnaires (study and sexual practices), provide saliva, urine and a blood sample. Following anaesthesia, oropharyngeal brushings and a tonsillectomy will be performed and all the samples will be processed for evidence of HPV infection.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tonsillectomy | – | –Subjects undergoing tonsillectomy for non-cancer reasons including operations for: recurrent tonsillitis, asymmetric tonsils, snoring surgery or obstructive sleep apnoea. |
Who may qualify
- Ages
- Up to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoing a tonsillectomy operation for non-cancerous reasons at the hospital will be recruited for this study.
Key inclusion criteria (3 listed)
- Subjects undergoing tonsillectomy for non cancer reasons including operations for: recurrent tonsillitis, asymmetric tonsils, snoring surgery or obstructive sleep apnoea
- Age - 0 to 65 years
- Subject or legal guardian has given informed written consent
Key exclusion criteria (3 listed)
- Subjects undergoing adenoidectomy alone with no tonsillectomy
- Subjects with previous oropharyngeal cancer or oral cancer, or any other head and neck cancer such as nasopharyngeal or laryngeal cancer that is currently undergoing or has previously been diagnosed or treated
- Learning disability preventing an adult over 16 years old from giving their own consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Occurrence of HPV in tonsils and in oral scrape sample
Time frame: 36 months
Presence of HPV result
1 secondary outcome
HPV vaccination status
Time frame: 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Chronic Tonsillitis
Not yet recruiting
Recovery From Tonsil Surgery.
Recurrent Tonsillitis, Chronic Tonsillitis
Active, not recruitingObservational study
A Comparative Study of Monopolar Versus Bipolar Electrocautery Post Tonsillectomy Outcomes.
Chronic Tonsillitis
Active, not recruiting
Intracapsular Tonsillectomy in Adults
Tonsil Disease, Tonsillitis
Recruiting
The Effect of Systemic Nonsteroidal Anti-inflammatory Drugs (NSAIDs) Vs Intraoperative Infiltration of Steroids in Tonsillar Bed Following Tonsillectomy on Post Tonsillectomy Pain.
Tonsillitis Chronic, Tonsillitis Recurrent
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.
Hisham Mehanna, Prof principal investigator
The University of Birmingham
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Tonsillitis, run by University of Birmingham at 8 sites 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 3 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: finished, as of the sponsor's last update on 18 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of HPV in tonsils and in oral scrape sample (time frame: 36 months). 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 18 May 2017.