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

Recruiting now · Not applicable

Conditions studied: Vulvar Cancer, Cervical Cancer, Vulvar Dysplasia, Cervical Dysplasia, Anal Cancer, Anal Dysplasia, HPV-Related Anal Squamous Cell Carcinoma

In brief

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.

Key facts

Study ID

NCT03061435

Run by

Dr. Danielle Vicus

People needed

110

Starts

2021-02-01

Expected to finish

2026-01-01

Last updated by the study team

2025-05-16

Who can join

Age: 40 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Women age ≥ 40
• Previous diagnosis of VIN 2/3 or vulvar

You may not qualify if…

• 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 is running

• Odette Cancer Centre — Toronto, Ontario, Canada (enrolling)

Full record on ClinicalTrials.gov

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