A trial to establish whether laser treatment of anal precancer prevents development of anal cancer in HIV-positive men who have sex with me

Not Applicable

• Conditions: Topic: Cancer; Subtopic: Colorectal Cancer; Disease: Anus; Cancer; Colorectal Cancer

• Registration Number: ISRCTN14067023
• Lead Sponsor: Homerton Hospital Anal Neoplasia Service (HANS)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-07-15
• Last Update Posted: 17 June 2019
• Study Completion: 2021-09-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: Male
• Target Recruitment: 3500

Inclusion Criteria

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

Exclusion Criteria

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of anal cancer in treatment arm compared to observation arm through the trial period; Timepoint(s): Over course of trial = 72 months