At a glance
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ANCHOR Study: Anal Cancer/HSIL Outcomes Research Study
In Brief
A Phase 3 clinical trial evaluating imiquimod, fluorouracil, and 5 other interventions for Anal Cancer and 3 related conditions. Completed, enrolled 4,446 participants across 25 sites in 2 countries.
Detailed Summary
The randomized phase of the trial compared topical or ablative treatment with active monitoring in preventing anal cancer in patients with human immunodeficiency virus (HIV) and high-grade squamous intraepithelial lesions (HSIL). Anal HSIL is tissue in the anal canal that has been damaged by infection with human papillomavirus (HPV) and is at risk for turning into anal cancer. The ANCHOR Data Safety Monitoring Board (DSMB) determined that the primary study endpoint was completed, based on the data and statistical analysis presented to them on 07SEP2021. In the post-randomization phase of this trial, all enrolled participants are offered treatment for HSIL and/or follow-up, at the participant's choice.
Study Details
Timeline
Interventions
Applied topically
Applied topically
Undergo infrared coagulation
Undergo hyfrecation/electrocautery therapy
Undergo laser therapy
Undergo active monitoring (High Resolution Anoscopy \[HRA\]) with biopsies
Correlative studies