RecruitingNot ApplicableNCT03061435

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


Sponsor

Dr. Danielle Vicus

Enrollment

110 participants

Start Date

Feb 1, 2021

Study Type

INTERVENTIONAL

Conditions

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-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.


Eligibility

Sex: FEMALEMin Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This study screens women who have had high-grade vulvar precancer (a condition called VIN 2/3) or vulvar cancer for signs of anal cancer — since both conditions are driven by the same virus (HPV, human papillomavirus) and tend to occur together, meaning women with one are at higher risk for the other. **You may be eligible if...** - You are a woman aged 40 or older - You have a prior diagnosis of high-grade vulvar intraepithelial neoplasia (VIN 2/3) or vulvar cancer - You are willing to undergo anal cancer screening as part of this study **You may NOT be eligible if...** - You have been previously diagnosed with any other cancer (except basal cell skin cancer, cervical cancer, or vulvar cancer) - You are HIV positive - You are currently taking medications that suppress your immune system (immunosuppressants) - You have previously had a hysterectomy (surgical removal of the uterus) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREScreening anal Pap smear - No high-resolution anoscopy

75% of patients with negative cytology on their anal Pap smear will not receive high-resolution anoscopy

PROCEDUREScreening anal Pap smear - High-resolution anoscopy

25% of patients with negative cytology on their anal Pap smear will receive high-resolution anoscopy. All patients with positive (abnormal) cytology on their anal Pap smear will receive high-resolution anoscopy.


Locations(1)

Odette Cancer Centre

Toronto, Ontario, Canada

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NCT03061435


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