Actively Recruiting

Phase Not Applicable
Age: 40Years +
FEMALE
Healthy Volunteers
NCT03061435

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

256 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Almost half of all women will develop an HPV infection in their lifetime. While most infections are naturally asymptomatic or cleared by the immune system, some persist and can lead to the development of cervical, vulvar, or anal lesions and eventually cancer. Screening regimens for these lesions are currently only in place for the cervix through regular Pap tests. These Pap tests usually involve an examination of the vulva -however, no screening procedures exist for anal cancer for women. Several studies have suggested that women with existing gynecological lesions are more likely to develop anal lesions and anal cancer. Here the investigators propose a multi-center study which seeks to screen for and treat anal cancer in women over the age of 40 with vulvar lesions and a stable immune system. The investigators will achieve this through performing anal Pap smears on eligible women and conducting High Resolution Anoscopy (HRA) and appropriate treatment procedures on those with abnormal anal cells. With enough evidence, there may be an indication to establish regular anal cancer screening measures in this potentially underserved population. Hypothesis: The investigators hypothesize that at least 40% of women with vulvar cancer or VIN2/3 will have abnormal anal cytology. 35% of the population will be hrHPV DNA positive and 11% will additionally have AIN2/3. This prospective study may lay the groundwork for routine anal screening regimens in Ontario and help shift health policy to treat this population.

CONDITIONS

Official Title

Screening for Anal Cancer in Women With High-grade Vulvar Dysplasia or Vulvar Cancer.

Who Can Participate

Age: 40Years +
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Women age 40 or older
  • Previous diagnosis of vulvar intraepithelial neoplasia 2 or 3 (VIN 2/3) or vulvar cancer
Not Eligible

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

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3
+1

Trial Site Locations

Total: 1 location

1

Odette Cancer Centre

Toronto, Ontario, Canada, M4N 3M5

Actively Recruiting

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Research Team

N

Nithla Mohanathas, BSc

CONTACT

A

Anika Mohan, BSc

CONTACT

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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