Screening for anal cancer in women with vulvar lesions
Official title: Screening for Anal Cancer in Women With High-grade Vulvar Dysplasia or Vulvar Cancer.
Run by Sunnybrook Health Sciences Centre · NCT03061435 · Data updated 2026-11-12
This study is testing if screening for anal cancer with Pap smears can help women over 40 who have vulvar lesions catch any problems early and improve their health.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 40 Years and up |
| Sex | Women only |
| Enrollment | 110 (estimated) |
| Sponsor | Sunnybrook Health Sciences Centre Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Status | Recruiting |
| Started | February 1, 2021 |
| Main results expected | August 1, 2025 |
| Study ends | January 1, 2026 |
| Registry record updated | May 16, 2025 |
| Trial ID | NCT03061435 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are women aged 40 and older with a previous diagnosis of high-grade vulvar dysplasia or vulvar cancer.
✕Probably not a fit
Patients who have a history of other cancers (except for basal cell carcinoma), are HIV positive, or are on immunosuppressant medications may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to screen women over the age of 40 who have high-grade vulvar dysplasia or vulvar cancer for anal cancer, which currently lacks established screening protocols. Participants will undergo anal Pap smears and, if abnormalities are detected, high-resolution anoscopy for further evaluation and treatment. The study is based on the premise that women with gynecological lesions are at increased risk for anal lesions and cancer. By identifying and treating anal cancer early, the study seeks to improve patient outcomes.
Why it matters
Potential benefit: If successful, this study could lead to early detection and treatment of anal cancer in women at high risk, potentially improving survival rates.
How similar studies have gone: While screening for anal cancer in this specific population is novel, previous studies have indicated a higher risk of anal lesions in women with gynecological cancers, suggesting potential for success.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women age ≥ 40 * Previous diagnosis of VIN 2/3 or vulvar Exclusion Criteria: * Women with a previous diagnosis of cancer aside from basal cell carcinoma of the skin, cervical cancer, or vulvar cancer * Women who are HIV positive * Women currently taking immunosuppressant medication * Women who have had a previous hysterectomy
Where it's running
-
Odette Cancer Centre
Toronto, Ontario, Canada Recruiting
Study contacts
- Principal investigator: Danielle Vicus, MD — Odette Cancer Centre
- Study coordinator: Nithla Mohanathas, BSc
- Email: nithla.mohanathas@sunnybrook.ca
- Phone: 4164805000
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.