Clinical trial NCT03061435: 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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Vulvar Cancer
Cervical Cancer
Vulvar Dysplasia
Cervical Dysplasia
Anal Cancer
Anal Dysplasia
HPV-Related Anal Squamous Cell Carcinoma
Keywords: Vulvar Cancer
Cervical Cancer
Vulvar Dysplasia
Cervical Dysplasia
Anal Cancer
Anal Dysplasia
HPV
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2017-02-23
Enrollment: 110
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.


Eligibility criteria: 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

Primary outcomes:
measure: Prevalence of abnormal anal cytology and hrHPV DNA in women with VIN 2/3 or vulvar cancer
timeFrame: 6 months to 1 year
Secondary outcomes:
measure: Prevalence of AIN in women with VIN 2/3 or vulvar cancer
timeFrame: 6 months to 1 year
measure: Assess t he correlation between abnormal anal cytology, hrHPV DNA, and AIN
timeFrame: 6 months to 1 year
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Odette Cancer Centre
state: Ontario
Study officials:
affiliation: Odette Cancer Centre
name: Danielle Vicus, MD
role: PRINCIPAL_INVESTIGATOR
References: