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

  • days left to enroll
  • participants needed
  • sponsor
    Dr. Danielle Vicus
Updated on 1 March 2022
cancer screening
screening procedures
hpv vaccine
anal intraepithelial neoplasia 2
vulvar dysplasia
anal pap smear
pap smears
pap smear
human papilloma virus vaccine
hpv infection
PAP test
Accepts healthy volunteers


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.

Condition Vulvar Cancer, Cervical Cancer, Vulvar Dysplasia, Cervical Dysplasia, Anal Cancer, Anal Dysplasia, HPV-Related Anal Squamous Cell Carcinoma
Treatment Screening anal Pap smear - No high-resolution anoscopy, Screening anal Pap smear - High-resolution anoscopy
Clinical Study IdentifierNCT03061435
SponsorDr. Danielle Vicus
Last Modified on1 March 2022


Yes No Not Sure

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
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