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Clinical Trials/NCT03061435
NCT03061435RecruitingNot Applicable

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

Dr. Danielle Vicus2 sites in 1 country110 target enrollmentStarted: February 1, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
110
Locations
2
Primary Endpoint
Prevalence of abnormal anal cytology and hrHPV DNA in women with VIN 2/3 or vulvar cancer

Study Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Screening
Masking
None

Eligibility Criteria

Ages
40 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

Prevalence of abnormal anal cytology and hrHPV DNA in women with VIN 2/3 or vulvar cancer

Time Frame: 6 months to 1 year

Secondary Outcomes

  • Assess t he correlation between abnormal anal cytology, hrHPV DNA, and AIN(6 months to 1 year)
  • Prevalence of AIN in women with VIN 2/3 or vulvar cancer(6 months to 1 year)

Investigators

Sponsor
Dr. Danielle Vicus
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Dr. Danielle Vicus

Dr. Danielle Vicus, MD, MSc, FRCSC

Sunnybrook Health Sciences Centre

Study Sites (2)

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