Plain-English translation of NCT03061435 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
This study doesn't follow the usual testing phases — it may be an observational study or a different type of research.
This research study is testing whether women with vulvar lesions or vulvar cancer should be screened for anal cancer. Researchers will perform a simple anal swab test (similar to a Pap smear for the cervix) on eligible women to look for abnormal cells. If abnormal cells are found, participants may have a follow-up procedure called high-resolution anoscopy to get a better look at the tissue and provide treatment if needed.
Right now, doctors screen women for cervical cancer regularly, but there is no routine screening for anal cancer — even though women with vulvar lesions appear to have a higher risk of developing it. This study aims to gather evidence about whether screening these women could help catch anal cancer earlier and potentially save lives.
You likely qualify if…
You likely don't qualify if…
If you enroll, you will receive an anal Pap smear (a quick swab test similar to cervical screening). Most participants will complete the study after this single test. However, some participants may be randomly selected for an additional visit to a high-resolution anoscopy clinic, where doctors use a special magnifying scope to examine the anal tissue more closely. If your swab test shows abnormal cells, you will be referred to the high-resolution anoscopy clinic for further evaluation and possible treatment.
AI-generated summary from trial data · Jun 30, 2026 · Not medical advice
Canada
Sponsor
Dr. Danielle Vicus
Enrollment target
~110 participants
Started
February 2021
Primary completion
August 2025
This trial's estimated completion date has passed — the record may not be fully up to date.
Age range
40 Years and older
Sex
Female only
Last updated on clinicaltrials.gov in May 2025.
Reach out to the team running this trial. Response times vary — some teams are faster than others.
Central contact
Nithla Mohanathas, BSc
Odette Cancer Centre
Tell us you're interested and we'll help connect you with the research team. We'll walk you through what to expect first — no email needed to get started.