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.

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Trial Summary

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Trial Protocol

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