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Actively Recruiting

Phase Not Applicable
Age: 40Years +
FEMALE
Healthy Volunteers
ID03061435

Screening for Anal Cancer in Women Aged 40 and Older 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

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.

Research Team

N

Nithla Mohanathas, BSc

A

Anika Mohan, BSc

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