Anal Cancer Clinical Trial
— HPV-SAVEOfficial title:
A Randomized Controlled, Open-label Trial Examining the Efficacy, Safety, and Tolerability of Ablative Therapies for High-grade Anal Dysplasia Versus Observation Alone in HIV-positive Men Who Have Sex With Men (MSM)
NCT number | NCT02503111 |
Other study ID # | CTN 292B |
Secondary ID | |
Status | Terminated |
Phase | N/A |
First received | |
Last updated | |
Start date | November 2015 |
Est. completion date | April 14, 2022 |
Verified date | June 2022 |
Source | University Health Network, Toronto |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Human papillomavirus (HPV) is the most common sexually transmitted infection worldwide. Infection by certain high-risk oncogenic types of HPV (HR-HPV) is the major cause of several cancers in men, notably squamous cell carcinoma (SCC) of the anal canal. Rates of anal infection with these HR-HPV strains and the resultant high-grade anal dysplasia and anal cancer are much higher in men who have sex with men (MSM) than in the general population. Co-infection with human immunodeficiency virus (HIV) further amplifies this burden, making the rates of anal SCC in HIV-positive MSM higher than the historic rates of cervical cancer prior to the adoption of routine cervical cytology screening. Despite these alarming statistics, there are no established protocols for optimal screening and treatment of anal HPV and cancer precursors, nor has there been any widespread rollout of organized screening programs anywhere in Canada. Further, not only does HPV directly cause significant disease in these men, but there is growing epidemiologic evidence that HPV infection may enhance sexual transmission of HIV. These significant knowledge gaps translate into fundamental deficiencies in care for HIV-positive MSM. The HPV Screening and Vaccine Evaluation in MSM (HPV-SAVE) study team will recruit a large group of MSM from various Ontario and Vancouver clinics, in order to carry out a number of different studies. The HPV-SAVE team brings together community and internationally-recognized experts in HPV and HIV disease and mucosal immunology, to better define the optimal approaches for primary and secondary prevention and treatment of HPV-associated anal disease among HIV-positive MSM, and to explore biological mechanistic evidence regarding the potential role of HPV as a co-factor for HIV transmission. This will yield critical information which can lead to improvement in the health of MSM, and will provide a foundation on which to build further, large-scale screening and treatment trials on a national level. The primary aim of the current study is to systematically compare ablative therapy versus intensive observation alone (also known as 'watchful waiting') in outcomes relating to high-grade anal dysplasia.
Status | Terminated |
Enrollment | 71 |
Est. completion date | April 14, 2022 |
Est. primary completion date | November 1, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Males, aged =18 years at baseline; - Identify as a man who has sex with a men (MSM); - HIV-positive; laboratory documentation of HIV-1 infection; - For those on combination antiretroviral therapy (cART), the participant must be on a stable regimen; - An ability to give informed consent; - An ability to attend clinic for follow-up, including possible HRA and biopsy; - AIN-2 or -3 found on biopsy of anal canal lesion(s); - Willingness to be randomized to undergo ablative therapy or active surveillance. Exclusion Criteria: - Current or prior history of cancer of the anogenital regions (e.g. penile, anal, or rectal).; - Previous treatment of high grade dysplasia; |
Country | Name | City | State |
---|---|---|---|
Canada | Ottawa Hospital Research Institute | Ottawa | Ontario |
Canada | University Health Network - Toronto General Hospital | Toronto | Ontario |
Canada | BC Centre for Disease Control | Vancouver | British Columbia |
Canada | University of British Columbia | Vancouver | British Columbia |
Lead Sponsor | Collaborator |
---|---|
University Health Network, Toronto | Canadian Institutes of Health Research (CIHR), CIHR Canadian HIV Trials Network, Merck Sharp & Dohme LLC, Ontario HIV Treatment Network |
Canada,
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* Note: There are 22 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Anal dysplasia treatment on a per-patient basis | Histologic resolution of high-grade AIN after treatment completion, with ablative therapies or surveillance alone. Resolution of high-grade AIN will be defined as histologic diagnosis of AIN-1 or normal at the post treatment HRA. | Participants will be followed after post-treatment completion, an expected average of 6 months | |
Secondary | Resolution of high-grade AIN at 3 and 6 months after randomization, on a per-lesion basis | Resolution of high-grade AIN after treatment on a per-lesion basis. Histologic resolution of high-grade AIN after treatment completion, with ablative therapies or surveillance alone. Resolution of high-grade AIN will be defined as histologic diagnosis of AIN-1 or normal at the post treatment HRA. | Participants will be followed after post-treatment completion, an expected average of 6 months | |
Secondary | Recurrence rates of high-grade AIN | Recurrence rates of high-grade AIN following ablative therapy on a per lesion basis. | Participants will be followed post-treatment completion, at 12, 24 and 36 months after randomization | |
Secondary | Number of participants with adverse events | Number of participants assessed on safety, tolerability and acceptability of the different intervention arms and the different treatments in the ablative therapies arms. Evaluation of adverse events and questionnaire-assessed acceptability by intervention arms and ablative treatment type. | Participants will be followed after post-treatment completion, an expected average of 36 months | |
Secondary | Acceptability of treatment | Questionnaire-assessed acceptability by intervention arm | Within 6 months of randomization |
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