p16 and anal neoplasia.
Research type
Research Study
Full title
Risk factors for anal squamous intraepithelial lesions and p16 expression in anal samples.
IRAS ID
234869
Contact name
Mayura Nathan
Contact email
Sponsor organisation
Homerton University Hospital
Duration of Study in the UK
0 years, 9 months, 31 days
Research summary
p16 is currently the only recommended biomarker for anogenital precancerous lesions' histological grading, including anal and perianal intraepithelial neoplasia (AIN and PAIN). One of the major indications for using it is in cases of AIN2/PAIN2. This is important not only for grading but also for therapeutic decisions; AIN2 p16 negative lesions are downgraded to low-grade lesions, are not treated and AIN2 p16 positive, therefore high-grade lesions, are normally ablated.
There are several risk factors recognised for anal precancerous lesions, namely HIV-positivity, men who have sex with men (MSM), previous history of genital neoplasia, smoking,and pharmacologically induced immunosuppression. Information on how this risk factor for precancerous lesions can affect p16 expression on anal and perianal samples are lacking.
This study is a retrospective analysis of the Homerton Anal Neoplasia Service (HANS) medical records from January 2014 until June 2017, including all the AIN2/PAIN2 samples in which p16 was performed. The aim is to evaluate the relationship, if any, of risk factors for anal and perianal precancerous lesions and p16 expression.REC name
West Midlands - Solihull Research Ethics Committee
REC reference
17/WM/0376
Date of REC Opinion
12 Oct 2017
REC opinion
Favourable Opinion