Topic: Cancer
Conditions
Interventions
The treatment being tested is laser ablation. This involves burning the skin/other similar lining using laser where anal precancer was identified and involves a local burn. Patients in the treatment
Study Entry : Single Randomisation only
Sponsors
Homerton Hospital Anal Neoplasia Service (HANS)
Eligibility
Sex/Gender
Male
Inclusion criteria
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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of anal cancer in treatment arm compared to observation arm through the trial period; Timepoint(s): Over course of trial = 72 months | — |
Secondary
| Measure | Time frame |
|---|---|
| For all enrolled participants: 1. The rates of AIN 2 and/or AIN 3 detected in the population enrolled into the study.; Timepoint(s): Over the course of trial = 72 months 2. Risk factors for AIN 2 and/or AIN 3 and knowledge about HPV and anal cancer in participants with AIN2 and/or AIN3, compared to those who screened negative for AIN2 and/or AIN3 disease.; Timepoint(s): Over the course of the trial = 72 months For all randomised participants: 3. Proportion of clearance/regression/progression of high-grade AIN lesions in the treatment arm, compared to the observation arm.; Timepoint(s): Over the course of the trial = 72 months 4. Incidence of metachronous (new) lesions and the rate of recurrence of high-grade AIN disease after clearance in the treatment arm, compared to the observation arm.; Timepoint(s): Over the course of the trial = 72 months 5. Difference, if any, by quadrants of high-grade AIN disease in the treatment arm, compared to the observation arm as measured by the proportion of disease clearance/regression/progression.; Timepoint(s): Over the course of the trial = 72 months 6. Number of treatment episodes/treatment duration needed to clear high-grade AIN lesions, by quadrants of disease in the treatment arm. ; Timepoint(s): Over the course of the trial = 72 months 7. Proportion free of high-risk HPV types in the treatment arm, compared to the observation arm, at the end of the study. ; Timepoint(s): At end of trial = at 72 months 8. Incidence of anal cancer in the treatment arm compared to the observation arm stratified by HPV 16 detection. ; Timepoint(s): Over the course of the trial = 72 months 9. Health-related quality of life, as measured by Area Under the Curve for EQ-5D, in the treatment c compared to the observation arm at each visit post-randomisation. ; Timepoint(s): Over the course | — |
Countries
United Kingdom
Contacts
Public ContactJennifer Child
Outcome results
None listed