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

Homerton Hospital Anal Neoplasia Service (HANS)0 sites3,500 target enrollmentJuly 15, 2015

Overview

No summary available.

Registry

who.int

Start Date

July 15, 2015

End Date

September 30, 2021

Last Updated

6 years ago

Study Type

Interventional

Sex

Male

Sponsor

Homerton Hospital Anal Neoplasia Service (HANS)

•1\. HIV\-positive men who have sex with men (MSM) over 18 years of age (HIV status confirmed by patient’s HIV unit)
•2\. CD4 cell count of 350cells/µl or greater within twelve months of randomisation; if CD4 count is less than 350cells/µl the patient must be on highly active antiretroviral treatment for at least three months, confirmed by patient’s HIV unit
•3\. Not currently enrolled in any other intervention study about AIN or anal cancer
•4\. Willing to attend Homerton University Hospital NHS Foundation Trust for all treatment and follow up appointments if allocated to treatment arm of the study
•5\. Physical and mental capacity to give informed consent
•6\. Necessary level of verbal and/or reading comprehension of English to give informed consent
•Only patients with histologically proven AIN2 and/or AIN 3 disease within the previous four months will be eligible for randomisation for the second part of the trial

•1\. Previous laser or other ablative treatment for AIN/warts in both the anal and perianal regions (cryotherapy if NOT an exclusion critera; if they previously had ablative treatment for external AIN disease/warts and now present with untreated anal canal disease they will be eligible; and similarly, if they had previous anal canal ablative treatment for AIN disease/warts and now present with untreated external disease, they will be eligible to participate in the trial)
•2\. Any other topical or surgical treatment for AIN 2 and/or AIN 3 or anal/perianal warts in the previous six months
•3\. Previous or current diagnosis of anal cancer or under investigation for anal cancer
•4\. Unable or unwilling to attend treatment and followup visits at the Homerton hospital (if randomised to treatment arm) or follow up visits at their recruiting site (if randomised to observation arm)