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

Official Title

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

Summary:

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-centre 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.

Trial Description

Primary Outcome:

  • Prevalence of abnormal anal cytology and hrHPV DNA in women with VIN 2/3 or vulvar cancer
Secondary Outcome:
  • Prevalence of AIN in women with VIN 2/3 or vulvar cancer
  • Assess t he correlation between abnormal anal cytology, hrHPV DNA, and AIN

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society