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Evaluation of Cytology and HPV Testing for Anal Pre-cancer

Evaluation of cytology and HPV testing for testing for anal intraepithelial neoplasia in high-risk populations in the UK

InfectiousDiseases (co-adopted by Surgery)
Portfolio Eligibility
Automatically eligible
ISRCTN 69055668
MREC N° 12/NW/0204
UKCRN ID 12823
Research Summary
Anal cancer, like cervical cancer, involves infection with the human papilloma virus (HPV). Anal cancer is generally uncommon, but there are some people at increased risk. These include people whose immune system is impaired, for example because they have HIV infection, or have had a transplant and are taking drugs which suppress immunity, and men who have sex with men. It may be worthwhile offering such 'high risk' people testing for anal cancer; this would involve a liquid based cytology test for precancerous abnormal cell changes similar to that now used for NHS cervical screening, and possibly a test for high risk HPV. Liquid based cytology, because it filters off impurities, offers the ability to obtain a clear sample of cells from the anus. We do not yet have all the information needed to decide whether testing for anal cancer with the available technologies would be useful. This study is designed to make an initial evaluation of the utility of these tests; to test how easy it would be to recruit the at risk population; to find out what patients feel about screening; and to obtain up to date information for the UK on the numbers of people likely to have an abnormal test result at each stage of the testing process. This initial study involves 1000 people and 4 high risk groups will be tested: HIV positive men who have sex with men; HIV negative men and women who have anal intercourse; kidney transplant patients; and HPV positive women with a history of genital warts/abnormal cytology. Patients will be offered anal cytology and HPV tests, with further tests, including biopsy sampling of anal tissue for diagnosis, for those with abnormal cytology and/or positive HPV tests and, for comparison, for some with normal cytology and negative HPV tests. Those found to have abnormal cells would be offered treatment.
Study Type Interventional
Design Type Not specified, Screening
Disease(s) Infectious diseases and microbiology
All Surgery
Phase N/A
Current Status Closed - in follow-up
Closure Date 12/31/2014
Global Sample Size 600
Global Recruitment to Date
Geographical Scope Single Centre
Lead Country England
Main Inclusion Criteria
HIV positive men, HIV positive men and women who have anal intercourse attending NHS genitourinary medicine (GUM) clinics
Men who have sex with men (MSM), recruited through GUM clinics and specialist general practices
Immunosuppressed transplant recipients (men and women) attending transplant follow-up clinics.
Main Exclusion Criteria
Patients with prior history of anal neoplasia.
Chief Investigator(s)
Prof Henry Kitchener
Further details, please contact
Prof Henry Kitchener

Institute of Cardiovascular Sciences (University of Manchester)

Oxford Road
Greater Manchester
M13 9PL

Tel: 0161 27664616421
Funder(s) National Health Service Cancer Screening Programme
Sponsor(s) Central Manchester University Hospitals NHS Trust (CMFT)
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