SEPAC
Research type
Research Study
Full title
Screening and Early Detection to Prevent Anal Cancer; development of a biomarker screening tool
IRAS ID
264882
Contact name
RJC Gilson
Contact email
Sponsor organisation
University College London
Clinicaltrials.gov Identifier
Z6364106/2019/08/96, UCL Data Protection Registration number
Duration of Study in the UK
2 years, 4 months, 1 days
Research summary
This is a screening and early detection study to prevent anal cancer among HIV-positive men-who-have-sex-with-men aged 40 years or older.
The highest risk group for anal cancer is HIV-positive men-who-have-sex-with-men (MSM) with an estimated incidence of 70–130/100,000. This is 2 to 4 times the rate of cervical cancer in the UK at the time that the cervical screening was introduced in the 1980s.
Unlike cervical disease, there is no national screening programme for anal cancer. However, the pathogenesis of anal cancer has similarities to cervical cancer including the association with human papillomavirus (HPV) infection (>80% are HPV16 positive) and a pre-cancer phase characterised by anal intraepithelial neoplasia (AIN). The gold-standard test for AIN is high-resolution anoscopy (HRA) and biopsy, analogous to cervical colposcopy, requiring specific training. HRA as primary screening has never been implemented; it is burdensome for patients, expensive and difficult to resource.
This study aims to develop and evaluate a primary screening tool for anal pre-cancer that would allow the identification and treatment of early disease, thus reduce the morbidity and mortality associated with anal cancer. We will recruit 1000 HIV-positive MSM aged 40 years or older from five participating HIV clinics across England. All participants will undergo HRA and have samples taken for biomarker analysis.
The objective of the study is to determine the sensitivity and specificity of a panel of biomarkers to detect high grade AIN lesions in an at-risk population. The screening tool developed as part of this study will facilitate natural history studies and enable controlled trials of early treatment to be conducted. It will also be essential for any subsequent screening and management pathway for the prevention of anal cancer in at-risk populations.
REC name
London - Westminster Research Ethics Committee
REC reference
19/LO/1735
Date of REC Opinion
20 Dec 2019
REC opinion
Further Information Favourable Opinion