Screening Tools for Anal Cancer Study (STACS)
Research type
Research Study
Full title
Screening Tools for Anal Cancer Study(STACS)
IRAS ID
144861
Contact name
Karly Louie
Contact email
Duration of Study in the UK
1 years, 2 months, 31 days
Research summary
Anal cancer is a growing burden in the UK and elsewhere, alarmingly higher among human immunodeficiency virus (HIV)-positive men who have sex with men (MSM). Unfortunately, highly active antiretroviral therapy (HAART) has not reduced the incidence of anal cancer in HIV-positives and their risk of anal intraepithelial neoplasia (AIN) has increased at least three-fold from the pre-HAART era in the UK. Unlike cervical screening where the benefits of screening to prevent cervical cancer are well-established, the benefits of anal screening to prevent anal cancer are unknown. The proposed feasibility study will provide primary data on the comparative diagnostic performance of anal cytology, HPV DNA and DNA methylation to detect high-grade AIN or greater (=HGAIN) and to identify the best swab test for anal cytology specimen collection.
180 HIV-positive MSM who have been referred for anal screening and attending an outpatient specialist clinic for AIN will be recruited. Participants will be asked to provide an additional cytology sample with a Dacron swab aside from the routine cytology sample normally taken with a Flocked swab. The participants will also complete a questionnaire about their lifestyle and sexual behaviours. As part of routine practice care, all participants will undergo high resolution anoscopy (HRA) and biopsies will be taken if any suspicious lesions are identified. Anal cytology and histology will be determined. Routine clinical data for cytology and histology results will be extracted from the patient’s medical records. Residual cytology specimens will be tested for cellularity, human papillomavirus (HPV)-positivity and DNA methylation. Histology specimens will also be tested for DNA methylation.
Results from this exploratory study will inform on the design of a large screening trial to evaluate the efficacy of anal screening to detect =HGAIN in HIV-positive MSM.
REC name
London - London Bridge Research Ethics Committee
REC reference
14/LO/1952
Date of REC Opinion
12 Feb 2015
REC opinion
Further Information Favourable Opinion