Actively Recruiting
Screening for Anal Cancer in Women With High-grade Vulvar Dysplasia or Vulvar Cancer.
Led by Dr. Danielle Vicus · Updated on 2025-05-16
110
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying anal cancer screening in women over 40 who have high-grade vulvar dysplasia or vulvar cancer. Many women develop HPV infections, which can lead to lesions and cancers in the cervix, vulva, or anus. While cervical cancer screening is common, there is currently no routine screening for anal cancer in these women. This multi-center study aims to determine how common abnormal anal cells and HPV are in this group, which could support new screening guidelines. All participants will have an anal Pap smear test. About 75% of women with a normal anal Pap will finish the study without further tests. The remaining 25% with normal Pap results and all women with abnormal Pap results will have a high-resolution anoscopy (HRA) exam to closely check the anal area and possibly receive biopsies or treatment as needed. Participants will be monitored for up to one year to measure the presence of abnormal anal cells, high-risk HPV DNA, and anal intraepithelial neoplasia. Researchers will assess how these factors relate to one another. The study involves tests like anal Pap smears and HRA exams to detect early signs of anal cancer and HPV infections, with follow-up care as required.
CONDITIONS
Brief Title
Screening for Anal Cancer in Women With High-grade Vulvar Dysplasia or Vulvar Cancer.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women age 60 40
- Previous diagnosis of VIN 2/3 or vulvar cancer
You will not qualify if you...
- Women with a previous diagnosis of cancer other than 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Odette Cancer Centre
Toronto, Ontario, Canada, M4N 3M5
Actively Recruiting
Research Team
N
Nithla Mohanathas, BSc
A
Anika Mohan, BSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
SCREENING
Number of Arms
3
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