LOPAC Laser Ablation versus Observation to Prevent Anal Cancer v.1.0
Research type
Research Study
Full title
A randomised controlled trial to study the effectiveness of Laser Ablation versus Observation to Prevent Anal Cancer in men who have sex with men with human immunodeficiency virus infection who have high-grade anal intraepithelial neoplasia (AIN 2 and/or AIN 3) disease (The LOPAC Trial)
IRAS ID
167040
Contact name
Jennifer Child
Contact email
Sponsor organisation
Homerton University Hospital NHS Foundation Trust
Duration of Study in the UK
6 years, 0 months, 0 days
Research summary
Anal cancer is a growing problem the UK. It disproportionately affects HIV-positive men who have sex with other men (MSM). Almost 90% of anal cancers are caused by the human papillomavirus (HPV). HPV infection in a weakened immune system can lead to abnormal cell changes in and around the anus, which are graded as anal intraepithelial neoplasia (AIN 1, AIN 2 and AIN 3), with AIN 2 and AIN 3 considered to be high-grade AIN disease. These changes are called precancers, but it is not known how many, and over what time period, will turn into cancer. Many doctors and scientists think these abnormal cells need to be treated, as is done in women for cervical precancer to prevent cancer. However, currently there is no proven treatment for anal precancer that will prevent anal cancer.
The main aim of the study is to assess whether laser treatment is effective in preventing anal cancer in HIV-positive MSM identified to have high-grade AIN disease. About 3,500 HIV-positive MSM will be recruited into the trial from four to five HIV units across London and screened for anal precancer. We estimate that between 25% and 30% of those screened will have precancerous changes. 660 participants with high-grade AIN disease (of the 3,500 enrolled participants) will be randomly assigned into two study arms: 330 patients in group 1 will be treated with laser, and patients in group 2 will have active surveillance (no treatment). All patients will be followed up every six months with a standard examination, consisting of high-resolution anoscopy (HRA), a digital rectal examination (DRE) and biopsy of persistent or new AIN 2 and/or AIN 3 or other areas suspected of cancer. Recruitment into the study will last 36 months and the total duration of the trial is 72 months.
REC name
London - London Bridge Research Ethics Committee
REC reference
15/LO/0942
Date of REC Opinion
2 Jul 2015
REC opinion
Further Information Favourable Opinion