OROMOUTH: HPV prevalance in the mouth and oropharynx of the tonsillectomy

 Chief Investigator:
 Prof Hisham Mehanna
 Sponsor:  University of Birmingham
 Funder:  GlaxoSmithKline
Disease Site:   Head and Neck
 Trial Type:   Non-IMP Study
 Status:  Closed
 UKCRN Study ID (if applicable):  N/A
 ISRCTN Referance Number:  N/A
 Open to New Sites?  Yes
 Recruitment Start Date: 15-Mar-2013
 Recruitment End Date: 28-Sep-2015
 CRCTU Trial Management Team:  Late Phase Trial Management Team- B
 Trial Email Address:  oromouth@trials.bham.ac.uk

Oromouth is sample collection study involving HPV detection in the tonsil histology, finger tips/nail brushings, oropharyngeal scrape samples, oral fluid, urine and serum samples. The Oromouth study aims to provide current data on the prevalence, distribution and natural history of HPV infection in the mouth, which are essential requirements for the assessment, development and evaluation of cost-effectiveness of prophylactic vaccination and screening programmes.

Oromouth closed to recruitment September 2015 having recruited 937 patients (including adults, adolescents and children) from 8 centres around the UK. Preliminary analysis showed that oral HPV is common in tonsillectomy patients. The baseline prevalence of oral HPV from our preliminary results in UK adults is 14.1%. In children the oral HPV prevalence is 2.4%. Significant associated risk factors include alcohol consumption, history of previous smoking, previous sexually transmitted infection and abnormal cervical smear. The preliminary results have been presented at numerous meetings.

Please note that the trials team cannot give individual’s clinical advice. Patients and their families should contact their treating physician to discuss trials for which they may be eligible.

Trial Summary

Trial Protocol

Please Note:
Clinical trial protocols are complex technical documents which should only be used for the treatment of subjects taking part in the trial. Patients who are interested in taking part in the trial are advised to talk to their health care professional.
Investigators please ensure you have R&D approval for this specific version of the protocol before using as a reference. 

Summary of Trial Results

A list of published abstracts is below:
Epidemiology and natural history of oral and oropharyngeal human papilloma virus infection in a UK multicentre cohort study – OROMOUTH. European Congress on Head and Neck Oncology (ECHNO) Liverpool UK, April 2014. Oral and Poster Presentation.
The impact of tonsillectomy on the natural history of oral human papilloma virus infection in healthy individuals: data from the UK OROMOUTH cohort. American HAED AND Neck Society (AHNS) 9th International Conference on Head and Neck Cancer, Seattle USA, 19 July 2016. Oral Presentation